BSD Medical Corp.
(Amex: BSM) reported today that the follow-up reviews of the presentation
of results from a 340 patient randomized Phase III clinical trial testing
the benefit of adding hyperthermia therapy to chemotherapy were both
positive and enthusiastic at the American Society of Clinical Oncology
(ASCO) conference, concluding in Chicago, Illinois. This year's ASCO was
attended by over 30,000 participants who specialize in clinical oncology.
In his review of the study, quoted by the ASCO Daily News, Dr. Fredrick C.
Eilber of UCLA called the "collaborative study 'impressive' and considers
it a 'tremendous effort' to find better treatment options for a disease
that is often fatal with local recurrence."
Several phase III clinical studies have shown significantly better
results in treating certain cancers when hyperthermia therapy was added to
radiation therapy, as compared to radiation treatments alone. Rolf D.
Issels, MD PhD, who presented the results of this new study at ASCO,
underscored the importance of this new study by explaining, "This is the
first randomized phase III clinical trial ever conducted on the use of
regional hyperthermia therapy in combination with standard chemotherapy. It
showed an approximate doubling of disease-free survival and local
progression-free survival for high risk soft tissue sarcoma patients when
hyperthermia therapy was added to chemotherapy, as compared to the results
for patients treated with chemotherapy alone."
While presenting the results of the study, Dr. Issels used a slide
showing a patient being treated with a BSD-2000 by BSD Medical Corp. to
accompany his statement: "The take-home message is that precise targeting
of regional hyperthermia can now be routinely applied to patients with
locally-advanced, high-grade soft tissue sarcoma." Results of the study
were formally presented at ASCO June 4 and were summarized again June 5 in
a general session of meeting highlights by Robert G. Maki, MD PhD, of
Memorial Sloan-Kettering Cancer Center.
The use of precision-focused mild heating of cancer (hyperthermia
therapy) during chemotherapy treatments opens cancer cells to better
absorption of chemotherapy drugs by improving blood flow as well as by
other biological mechanisms of action. Hyperthermia therapy also kills
cancer cells directly and can be used to improve chemical reactions of some
chemotherapy drugs.
This clinical study was sponsored by both the EORTC (European
Organization for Research and Treatment of Cancer) and ESHO (European
Society for Hyperthermic Oncology). Professor Rolf Issels, MD PhD of the
Klinikum Grosshadern Medical Center at the University of Munich, Munich,
Germany was principal investigator and presenter of the study results. The
study is listed by the National Cancer Institute as NCI number NCT00003052.
This clinical trial was supported by German Cancer Aid and the Association
of German Research Centers.
All hyperthermia treatments performed in the study were conducted using
BSD-2000 hyperthermia systems developed and produced by BSD Medical Corp.
The BSD-2000 hyperthermia therapy system non-invasively delivers precision
focused hyperthermia therapy to cancerous tumors, including tumors located
deep in the body.
About BSD Medical
BSD Medical Corp. is a leading developer of systems used to deliver
therapies involving precision-focused heat for the treatment of cancer. The
objective of the company is to deliver a complete solution in thermal
treatments for cancer, as provided by precision-focused microwave heating,
to support radiation oncologists, interventional radiologists, medical
oncologists and surgeons in providing more effective procedures and
treatments. For further information visit BSD Medical's website at
BSDMedical or BSD's patient website at
treatwithheat.
Statements contained in this press release that are not historical
facts are forward-looking statements, as defined in the Private Securities
Litigation Reform Act of 1995. All forward-looking statements are subject
to risks and uncertainties detailed in the Company's filings with the
Securities and Exchange Commission.
BSD Medical Corp.
BSDMedical
вторник, 31 мая 2011 г.
понедельник, 30 мая 2011 г.
Scientists Honored With 'Excellence In Clinical Research Award'
Mary Tyler Moore, the Juvenile Diabetes Research Foundation's International Chairman, and her husband S. Robert Levine, M.D., will present the fifth annual Excellence In Clinical Research Award to a group of pioneering researchers for their work in regenerating beta cells -- which are destroyed in type 1 diabetes -- as a way to delay the onset of type 1 diabetes. The award will be presented at JDRF's annual conference in St. Louis.
The award recipients are Stephen J. Brand, M.D., Ph.D., who co-founded Waratah Pharmaceuticals to further the development of beta cell regeneration; Tony Cruz, Ph.D., Chief Executive Officer and a founder of Toronto-based Transition Therapeutics, which merged with Waratah Pharmaceuticals; and Alex Rabinovitch, M.D., a Professor of Medicine, co-director of the Muttart Diabetes Research & Training Centre at the University of Alberta in Edmonton, and a member of the Scientific Advisory Board at Transition Therapeutics, Inc.
This year's recipients are being acknowledged for developing and testing beta cell regeneration therapy initially in preclinical research and now in the clinic. In early preclinical studies, these researchers discovered a combination of hormones that proved to be effective at regenerating the insulin producing beta cells that are lost when people develop type 1 diabetes. These researchers are investigating ways to stimulate the existing beta cells left in diabetes patients to regenerate by applying combination therapies. If combined with therapies that block the autoimmune attack, a treatment that spurs beta cell regeneration could potentially lead to a cure for type 1 diabetes.
"Robert and I are pleased to recognize this group of dedicated and accomplished scientists for their groundbreaking work and the impact they have made on advancing our cure goal of beta cell regeneration," said Mary Tyler Moore, who has been living with type 1 diabetes for nearly 40 years.
Stephen J. Brand, M.D., Ph.D., received his first JDRF research grant in the late 1980s to study the possible role of a growth factor called gastrin in pancreatic development and beta cell regeneration. In the 1990s, Dr. Brand and colleagues added another growth factor, EGF, to gastrin to develop a beta cell regenerative therapy, and in 2000 started a small biotech firm (Waratah Pharmaceuticals Corp.) to continue its development. In 2002, the firm merged with Transition Therapeutics, and Dr. Brand teamed with Dr. Alex Rabinovitch and two other colleagues to develop this new combination regenerative therapeutic called E1-I.N.T, which moved rapidly into human clinical trials and produced promising results. JDRF funding is now accelerating a second-generation version of this drug into Phase II clinical trials. Dr. Brand received his M.D. and Ph.D. from the University of Western Australia.
Tony Cruz, Ph.D., a scientist and entrepreneur, is one of the founders of Transition Therapeutics and Chief Executive Officer since its inception in July 1998. At Transition, Dr. Cruz has quickly advanced multiple products into clinical development, including combination therapies for beta cell regeneration. Previously, Dr. Cruz co-founded Angiotech Pharmaceuticals Inc, in Canada. He has been a senior scientist at Mt. Sinai Hospital in Toronto since 1995, was founder, CEO and President of the Canadian Arthritis Network, is the author of over 150 scientific publications, and has served as a consultant for biotechnology companies and investment firms. Dr. Cruz received his B.Sc. and Ph.D. in Chemistry and Biochemistry from the University of Toronto.
Alex Rabinovitch, M.D., is Professor of Medicine and co-director of the Muttart Diabetes Research & Training Centre at the University of Alberta, Edmonton. His work has advanced potential treatments for type 1 diabetes, including the use of growth factor peptides to regenerate islet cells leading to the development of and clinical trials for new compounds to induce beta cell regeneration. A JDRF-funded researcher for many years, Dr. Rabinovitch has received many awards and served on many professional committees and offices, including, since 2005, the role of co-Principal Investigator in the NIH''s Immune Tolerance Network. He has served on the Scientific Advisory Board of Transition Therapeutics since 2003.
The award, presented each year at the JDRF's annual conference, is named for JDRF International Chairman Mary Tyler Moore and S. Robert Levine M.D. in honor of their longtime extraordinary efforts and commitment to JDRF's mission to find a cure for diabetes and its complications through the support of research.
JDRF was founded in 1970 by the parents of children with type 1 diabetes - a disease that strikes children, adolescents, and adults suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1 billion to diabetes research worldwide. More than 85 percent of JDRF's expenditures directly support research and research-related education. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research. For more information please visit jdrf/
For additional information on Transition Therapeutics, please visit transitiontherapeutics/
Contact: Brenda Cheung
Juvenile Diabetes Research Foundation International
The award recipients are Stephen J. Brand, M.D., Ph.D., who co-founded Waratah Pharmaceuticals to further the development of beta cell regeneration; Tony Cruz, Ph.D., Chief Executive Officer and a founder of Toronto-based Transition Therapeutics, which merged with Waratah Pharmaceuticals; and Alex Rabinovitch, M.D., a Professor of Medicine, co-director of the Muttart Diabetes Research & Training Centre at the University of Alberta in Edmonton, and a member of the Scientific Advisory Board at Transition Therapeutics, Inc.
This year's recipients are being acknowledged for developing and testing beta cell regeneration therapy initially in preclinical research and now in the clinic. In early preclinical studies, these researchers discovered a combination of hormones that proved to be effective at regenerating the insulin producing beta cells that are lost when people develop type 1 diabetes. These researchers are investigating ways to stimulate the existing beta cells left in diabetes patients to regenerate by applying combination therapies. If combined with therapies that block the autoimmune attack, a treatment that spurs beta cell regeneration could potentially lead to a cure for type 1 diabetes.
"Robert and I are pleased to recognize this group of dedicated and accomplished scientists for their groundbreaking work and the impact they have made on advancing our cure goal of beta cell regeneration," said Mary Tyler Moore, who has been living with type 1 diabetes for nearly 40 years.
Stephen J. Brand, M.D., Ph.D., received his first JDRF research grant in the late 1980s to study the possible role of a growth factor called gastrin in pancreatic development and beta cell regeneration. In the 1990s, Dr. Brand and colleagues added another growth factor, EGF, to gastrin to develop a beta cell regenerative therapy, and in 2000 started a small biotech firm (Waratah Pharmaceuticals Corp.) to continue its development. In 2002, the firm merged with Transition Therapeutics, and Dr. Brand teamed with Dr. Alex Rabinovitch and two other colleagues to develop this new combination regenerative therapeutic called E1-I.N.T, which moved rapidly into human clinical trials and produced promising results. JDRF funding is now accelerating a second-generation version of this drug into Phase II clinical trials. Dr. Brand received his M.D. and Ph.D. from the University of Western Australia.
Tony Cruz, Ph.D., a scientist and entrepreneur, is one of the founders of Transition Therapeutics and Chief Executive Officer since its inception in July 1998. At Transition, Dr. Cruz has quickly advanced multiple products into clinical development, including combination therapies for beta cell regeneration. Previously, Dr. Cruz co-founded Angiotech Pharmaceuticals Inc, in Canada. He has been a senior scientist at Mt. Sinai Hospital in Toronto since 1995, was founder, CEO and President of the Canadian Arthritis Network, is the author of over 150 scientific publications, and has served as a consultant for biotechnology companies and investment firms. Dr. Cruz received his B.Sc. and Ph.D. in Chemistry and Biochemistry from the University of Toronto.
Alex Rabinovitch, M.D., is Professor of Medicine and co-director of the Muttart Diabetes Research & Training Centre at the University of Alberta, Edmonton. His work has advanced potential treatments for type 1 diabetes, including the use of growth factor peptides to regenerate islet cells leading to the development of and clinical trials for new compounds to induce beta cell regeneration. A JDRF-funded researcher for many years, Dr. Rabinovitch has received many awards and served on many professional committees and offices, including, since 2005, the role of co-Principal Investigator in the NIH''s Immune Tolerance Network. He has served on the Scientific Advisory Board of Transition Therapeutics since 2003.
The award, presented each year at the JDRF's annual conference, is named for JDRF International Chairman Mary Tyler Moore and S. Robert Levine M.D. in honor of their longtime extraordinary efforts and commitment to JDRF's mission to find a cure for diabetes and its complications through the support of research.
JDRF was founded in 1970 by the parents of children with type 1 diabetes - a disease that strikes children, adolescents, and adults suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1 billion to diabetes research worldwide. More than 85 percent of JDRF's expenditures directly support research and research-related education. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research. For more information please visit jdrf/
For additional information on Transition Therapeutics, please visit transitiontherapeutics/
Contact: Brenda Cheung
Juvenile Diabetes Research Foundation International
воскресенье, 29 мая 2011 г.
QRxPharma Initiates Second Pivotal Phase 3 Study Of MoxDuo(TM)IR Dual-Opioid(TM) For NDA Submission
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone. This two-arm study will compare the effectiveness and safety of a flexible MoxDuo™IR dose regimen to a fixed low dose for managing moderate to severe pain in patients who have undergone total knee replacement surgery. The Company expects to complete dosing in Q3 2010 in preparation for filing a New Drug Application (NDA) with the US Food and Drug Administration in Q4 2010. MoxDuo™IR targets the acute pain market, a $2.5 billion segment of over $7 billion spent annually on prescription opioids in the US.
"In support of our Phase 3 program, clinical trials conducted to date have consistently demonstrated MoxDuo™IR achieves as good or better pain relief with fewer incidences of moderate-severe side effects than morphine, oxycodone or Percocet®. Based on these data, we are optimistic about the competitive advantages of MoxDuo," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "With the initiation of the Company's second pivotal trial for MoxDuo™IR, we are one step closer to definitively proving the value of our Dual-Opioid™ product to potential partners, prescribers and patients."
In 2009, an open-label pilot study demonstrated improved analgesia of flexible dose MoxDuo™IR (individual doses up to 24mg morphine/16mg oxycodone) compared to fixed, low dose MoxDuo™IR (3mg morphine/2mg oxycodone) in patients with moderate to severe pain following total knee replacement surgery. Based on these results, low dose MoxDuo™IR was selected as the control for this pivotal trial.
Study 009, a randomised, double blind trial, is targeted to enroll 140 patients (70 per study Arm) at 8 US clinical research sites. Initially, all post-operative patients will receive intravenous patient controlled analgesia (PCA) morphine until the day following knee replacement surgery. At such time, PCA morphine dosing will be stopped. When pain becomes moderate to severe [based on the 10-point Numerical Pain Rating Scale (NPRS)], patients will then be randomised in equal numbers to receive either a flexible regimen of MoxDuo™IR (Arm 1) or the low dose control (Arm 2).
For patients assigned to the flexible dose regimen (Arm 1), the initial dose will be based on the Company's proprietary algorithm (developed in the prior open label study) that converts PCA morphine to oral morphine equivalents of MoxDuo™ IR. All Arm 1 patients will start on at least 12mg/8mg (morphine/oxycodone); patients in Arm 2 will receive a loading dose of 6mg/4mg followed by 3mg/2mg regardless of their initial PCA dosing regimen. All patients will be dosed every four to six hours over a 48-hour period.
The primary endpoint for evaluating the efficacy of flexible dose versus low dose is the difference from baseline in pain intensity scores for each treatment group over the 48-hour treatment period [Sum of Pain Intensity Differences over 48 hours (SPID(48)) calculated using the 10-point NPRS]. Secondary endpoints include: (1) efficacy relating to the time to onset of analgesia and global assessment of effect (i.e. total pain relief) as well as amount of supplemental analgesia used throughout the treatment period; and (2) safety as measured by incidence and intensity of opioid-related adverse effects.
To date, more than 500 patients experiencing pain following different surgical procedures (bunionectomy and total knee replacement) as well as non-surgical patients with chronic pain have received MoxDuo™IR. Study results consistently demonstrate MoxDuo™IR's greater overall tolerability allowing the doctors and patients to achieve as good or better pain relief with substantially fewer incidences of nausea, vomiting, constipation, dizziness, and hypotension. For example, at equal analgesic doses the frequency of moderate to severe adverse events was 50% to 75% lower among patients on MoxDuo™IR than those receiving morphine, oxycodone or Percocet® (oxycodone plus acetaminophen).
In December, 2009, QRxPharma announced the initiation of its first Pivotal Phase 3 (combination rule) study in bunionectomy patients to demonstrate that MoxDuo™IR provides superior analgesia compared to its component doses of morphine and oxycodone. According to the FDA, once these two pivotal studies are completed, no additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval. QRxPharma expects to complete its Phase 3 program in Q3 2010 and file its NDA for MoxDuo™IR by the end of year 2010.
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement. These statements are based on plans, estimates and projections as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events.
By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company's proposed products.
About QRxPharma
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain management and central nervous system (CNS) disorders. Based on a business strategy to expand the clinical utility and commercial value of marketed and/or existing compounds, QRxPharma's product portfolio includes both late and early stage clinical drug candidates with well-defined paths to regulatory approval and sales. The Company intends to directly commercialise its products in the US and seek strategic partnerships for worldwide markets.
QRxPharma's lead compound, MoxDuo™IR (Q8003IR), is in Phase 3 clinical development and has successfully completed multiple comparative studies evaluating its efficacy and safety against equianalgesic doses of morphine, oxycodone and Percocet® for the treatment of acute pain. Study results consistently demonstrate MoxDuo™IR's greater overall tolerability, achieving as good or better pain relief with substantially fewer incidences of moderate to severe side effects. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics.
"In support of our Phase 3 program, clinical trials conducted to date have consistently demonstrated MoxDuo™IR achieves as good or better pain relief with fewer incidences of moderate-severe side effects than morphine, oxycodone or Percocet®. Based on these data, we are optimistic about the competitive advantages of MoxDuo," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "With the initiation of the Company's second pivotal trial for MoxDuo™IR, we are one step closer to definitively proving the value of our Dual-Opioid™ product to potential partners, prescribers and patients."
In 2009, an open-label pilot study demonstrated improved analgesia of flexible dose MoxDuo™IR (individual doses up to 24mg morphine/16mg oxycodone) compared to fixed, low dose MoxDuo™IR (3mg morphine/2mg oxycodone) in patients with moderate to severe pain following total knee replacement surgery. Based on these results, low dose MoxDuo™IR was selected as the control for this pivotal trial.
Study 009, a randomised, double blind trial, is targeted to enroll 140 patients (70 per study Arm) at 8 US clinical research sites. Initially, all post-operative patients will receive intravenous patient controlled analgesia (PCA) morphine until the day following knee replacement surgery. At such time, PCA morphine dosing will be stopped. When pain becomes moderate to severe [based on the 10-point Numerical Pain Rating Scale (NPRS)], patients will then be randomised in equal numbers to receive either a flexible regimen of MoxDuo™IR (Arm 1) or the low dose control (Arm 2).
For patients assigned to the flexible dose regimen (Arm 1), the initial dose will be based on the Company's proprietary algorithm (developed in the prior open label study) that converts PCA morphine to oral morphine equivalents of MoxDuo™ IR. All Arm 1 patients will start on at least 12mg/8mg (morphine/oxycodone); patients in Arm 2 will receive a loading dose of 6mg/4mg followed by 3mg/2mg regardless of their initial PCA dosing regimen. All patients will be dosed every four to six hours over a 48-hour period.
The primary endpoint for evaluating the efficacy of flexible dose versus low dose is the difference from baseline in pain intensity scores for each treatment group over the 48-hour treatment period [Sum of Pain Intensity Differences over 48 hours (SPID(48)) calculated using the 10-point NPRS]. Secondary endpoints include: (1) efficacy relating to the time to onset of analgesia and global assessment of effect (i.e. total pain relief) as well as amount of supplemental analgesia used throughout the treatment period; and (2) safety as measured by incidence and intensity of opioid-related adverse effects.
To date, more than 500 patients experiencing pain following different surgical procedures (bunionectomy and total knee replacement) as well as non-surgical patients with chronic pain have received MoxDuo™IR. Study results consistently demonstrate MoxDuo™IR's greater overall tolerability allowing the doctors and patients to achieve as good or better pain relief with substantially fewer incidences of nausea, vomiting, constipation, dizziness, and hypotension. For example, at equal analgesic doses the frequency of moderate to severe adverse events was 50% to 75% lower among patients on MoxDuo™IR than those receiving morphine, oxycodone or Percocet® (oxycodone plus acetaminophen).
In December, 2009, QRxPharma announced the initiation of its first Pivotal Phase 3 (combination rule) study in bunionectomy patients to demonstrate that MoxDuo™IR provides superior analgesia compared to its component doses of morphine and oxycodone. According to the FDA, once these two pivotal studies are completed, no additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval. QRxPharma expects to complete its Phase 3 program in Q3 2010 and file its NDA for MoxDuo™IR by the end of year 2010.
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement. These statements are based on plans, estimates and projections as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events.
By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company's proposed products.
About QRxPharma
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain management and central nervous system (CNS) disorders. Based on a business strategy to expand the clinical utility and commercial value of marketed and/or existing compounds, QRxPharma's product portfolio includes both late and early stage clinical drug candidates with well-defined paths to regulatory approval and sales. The Company intends to directly commercialise its products in the US and seek strategic partnerships for worldwide markets.
QRxPharma's lead compound, MoxDuo™IR (Q8003IR), is in Phase 3 clinical development and has successfully completed multiple comparative studies evaluating its efficacy and safety against equianalgesic doses of morphine, oxycodone and Percocet® for the treatment of acute pain. Study results consistently demonstrate MoxDuo™IR's greater overall tolerability, achieving as good or better pain relief with substantially fewer incidences of moderate to severe side effects. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics.
суббота, 28 мая 2011 г.
Neurogen Commences Phase II Clinical Trial In Chronic Insomnia Patients
Neurogen Corporation
(Nasdaq: NRGN) today announced that it has commenced a Phase II clinical
trial in chronic insomnia patients with the Company's insomnia agent,
NG2-73. The study will measure reduction in time to onset of persistent
sleep and sleep maintenance across a range of doses and formulations during
two weeks of treatment. NG2-73 selectively modulates receptors of the
gamma-aminobutyric acid (GABA) neurotransmitter system and is one of
several unpartnered compounds in Neurogen's portfolio.
The Phase II clinical trial is a randomized, double-blind,
placebo-controlled, multi-center, parallel group study designed to
determine the efficacy and safety of five different dose and formulation
profiles of NG2-73 compared to placebo. The primary endpoint will be the
time it takes to fall asleep as defined by Latency to Persistent Sleep
(LPS). Sleep maintenance will be explored in several secondary endpoints.
At least 240 chronic insomniacs, aged up to 64 years, are expected to
receive study drug or placebo for 14 days. Polysomnography will be used to
measure various sleep parameters.
The study will test doses and formulations of NG2-73 which are expected
to span the therapeutic range. Doses to be tested include sustained release
formulations. The exposure/response relationships will also be examined and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilized to
facilitate dose and formulation optimization.
William H. Koster, President and CEO, said, "We are building on the
positive and highly significant results of our Phase II transient insomnia
study, where NG2-73 demonstrated dramatic improvement over placebo for LPS.
We now will seek to confirm the robust LPS response in chronic insomniacs
and begin to assess sleep maintenance, since insomniacs may suffer from
sleep initiation, sleep maintenance issues or both.
"Our target product profile for NG2-73 is a drug that provides quick
onset and reduces wake time through the night, with patients awakening
feeling refreshed and with no hangover effects. In order to expand and
intensify our knowledge of doses and formulations of NG2-73 for duration of
action, we plan to launch an additional concurrent study in insomniacs
later this year."
About Neurogen's Insomnia Program
Neurogen previously announced results from Phase II human testing in
transient insomnia for NG2-73. The primary endpoint of the study measured
the efficacy of NG2-73 in reducing time to onset of persistent sleep in a
well established clinical model of transient insomnia in healthy adults. In
the multi-center, 369 subject study, NG2-73 was shown to significantly
reduce time to onset of persistent sleep versus placebo at all doses
tested. NG2-73 was well-tolerated at all doses, with no drug-related
serious adverse events or drug-related premature subject withdrawals.
Prescription drugs dominating the insomnia market work by modulating
the GABA-A system of neurotransmitters. GABA is a chemical naturally
released in certain parts of the brain in order to inhibit brain activity.
Preclinical studies suggest that NG2-73 is pharmacologically distinct from
currently marketed insomnia agents, as well as those in development. These
studies with NG2-73 compared to the other GABA hypnotic agents that are
potent agonists at multiple receptor subtypes, indicate that NG2-73 may
provide the benefit of sleep with a reduction in next day side effects.
Webcast
Neurogen will host a conference call and webcast to discuss this
announcement at 11:00 a.m. ET today, October 30, 2006. The webcast will be
available in the Investor Relations section of neurogen and
will be archived on the website until December 31, 2006. A replay of the
call will be available after 1:00 pm ET today and accessible through the
close of business November 20, 2006. To replay the conference call, dial
888-286-8010, or for international callers, 617-801-6888, and use the pass
code: 43091770.
About Neurogen Corporation
Neurogen Corporation is a drug discovery and development company
focusing on small molecule drugs to improve the lives of patients suffering
from disorders with significant unmet medical need, including insomnia,
pain, depression, and obesity. Neurogen has generated a portfolio of
compelling new drug candidates through its Accelerated Intelligent Drug
Discovery (AIDD(TM)) system, its expertise in cellular functional assays,
and its depth in medicinal chemistry. Neurogen conducts its research and
development independently and, when advantageous, collaborates with
world-class pharmaceutical companies.
Safe Harbor Statement
The information in this press release contains certain forward-looking
statements, made pursuant to applicable securities laws, that involve risks
and uncertainties as detailed from time to time in Neurogen's SEC filings,
including its most recent 10-K. Such forward-looking statements relate to
events or developments that we expect or anticipate will occur in the
future and include, but are not limited to, statements that are not
historical facts relating to the timing and occurrence of anticipated
clinical trials, and potential collaborations or extensions of existing
collaborations. Actual results may differ materially from such
forward-looking statements as a result of various factors, including, but
not limited to, risks associated with the inherent uncertainty of drug
research and development, difficulties or delays in development, testing,
regulatory approval, production and marketing of any of the Company's drug
candidates, adverse side effects or inadequate therapeutic efficacy or
pharmacokinetic properties of the Company's drug candidates or other
properties of drug candidates which could make them unattractive for
commercialization, advancement of competitive products, dependence on
corporate partners, the Company's ability to retain key employees,
sufficiency of cash to fund the Company's planned operations and patent,
product liability and third party reimbursement risks associated with the
pharmaceutical industry. For such statements, Neurogen claims the
protection of applicable laws. Future results may also differ from
previously reported results. For example, positive results or safety and
tolerability in one clinical study provides no assurance that this will be
true in future studies. Neurogen disclaims any intent and does not assume
any obligation to update these forward-looking statements, other than as
may be required under applicable law.
Neurogen Corporation
neurogen
(Nasdaq: NRGN) today announced that it has commenced a Phase II clinical
trial in chronic insomnia patients with the Company's insomnia agent,
NG2-73. The study will measure reduction in time to onset of persistent
sleep and sleep maintenance across a range of doses and formulations during
two weeks of treatment. NG2-73 selectively modulates receptors of the
gamma-aminobutyric acid (GABA) neurotransmitter system and is one of
several unpartnered compounds in Neurogen's portfolio.
The Phase II clinical trial is a randomized, double-blind,
placebo-controlled, multi-center, parallel group study designed to
determine the efficacy and safety of five different dose and formulation
profiles of NG2-73 compared to placebo. The primary endpoint will be the
time it takes to fall asleep as defined by Latency to Persistent Sleep
(LPS). Sleep maintenance will be explored in several secondary endpoints.
At least 240 chronic insomniacs, aged up to 64 years, are expected to
receive study drug or placebo for 14 days. Polysomnography will be used to
measure various sleep parameters.
The study will test doses and formulations of NG2-73 which are expected
to span the therapeutic range. Doses to be tested include sustained release
formulations. The exposure/response relationships will also be examined and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilized to
facilitate dose and formulation optimization.
William H. Koster, President and CEO, said, "We are building on the
positive and highly significant results of our Phase II transient insomnia
study, where NG2-73 demonstrated dramatic improvement over placebo for LPS.
We now will seek to confirm the robust LPS response in chronic insomniacs
and begin to assess sleep maintenance, since insomniacs may suffer from
sleep initiation, sleep maintenance issues or both.
"Our target product profile for NG2-73 is a drug that provides quick
onset and reduces wake time through the night, with patients awakening
feeling refreshed and with no hangover effects. In order to expand and
intensify our knowledge of doses and formulations of NG2-73 for duration of
action, we plan to launch an additional concurrent study in insomniacs
later this year."
About Neurogen's Insomnia Program
Neurogen previously announced results from Phase II human testing in
transient insomnia for NG2-73. The primary endpoint of the study measured
the efficacy of NG2-73 in reducing time to onset of persistent sleep in a
well established clinical model of transient insomnia in healthy adults. In
the multi-center, 369 subject study, NG2-73 was shown to significantly
reduce time to onset of persistent sleep versus placebo at all doses
tested. NG2-73 was well-tolerated at all doses, with no drug-related
serious adverse events or drug-related premature subject withdrawals.
Prescription drugs dominating the insomnia market work by modulating
the GABA-A system of neurotransmitters. GABA is a chemical naturally
released in certain parts of the brain in order to inhibit brain activity.
Preclinical studies suggest that NG2-73 is pharmacologically distinct from
currently marketed insomnia agents, as well as those in development. These
studies with NG2-73 compared to the other GABA hypnotic agents that are
potent agonists at multiple receptor subtypes, indicate that NG2-73 may
provide the benefit of sleep with a reduction in next day side effects.
Webcast
Neurogen will host a conference call and webcast to discuss this
announcement at 11:00 a.m. ET today, October 30, 2006. The webcast will be
available in the Investor Relations section of neurogen and
will be archived on the website until December 31, 2006. A replay of the
call will be available after 1:00 pm ET today and accessible through the
close of business November 20, 2006. To replay the conference call, dial
888-286-8010, or for international callers, 617-801-6888, and use the pass
code: 43091770.
About Neurogen Corporation
Neurogen Corporation is a drug discovery and development company
focusing on small molecule drugs to improve the lives of patients suffering
from disorders with significant unmet medical need, including insomnia,
pain, depression, and obesity. Neurogen has generated a portfolio of
compelling new drug candidates through its Accelerated Intelligent Drug
Discovery (AIDD(TM)) system, its expertise in cellular functional assays,
and its depth in medicinal chemistry. Neurogen conducts its research and
development independently and, when advantageous, collaborates with
world-class pharmaceutical companies.
Safe Harbor Statement
The information in this press release contains certain forward-looking
statements, made pursuant to applicable securities laws, that involve risks
and uncertainties as detailed from time to time in Neurogen's SEC filings,
including its most recent 10-K. Such forward-looking statements relate to
events or developments that we expect or anticipate will occur in the
future and include, but are not limited to, statements that are not
historical facts relating to the timing and occurrence of anticipated
clinical trials, and potential collaborations or extensions of existing
collaborations. Actual results may differ materially from such
forward-looking statements as a result of various factors, including, but
not limited to, risks associated with the inherent uncertainty of drug
research and development, difficulties or delays in development, testing,
regulatory approval, production and marketing of any of the Company's drug
candidates, adverse side effects or inadequate therapeutic efficacy or
pharmacokinetic properties of the Company's drug candidates or other
properties of drug candidates which could make them unattractive for
commercialization, advancement of competitive products, dependence on
corporate partners, the Company's ability to retain key employees,
sufficiency of cash to fund the Company's planned operations and patent,
product liability and third party reimbursement risks associated with the
pharmaceutical industry. For such statements, Neurogen claims the
protection of applicable laws. Future results may also differ from
previously reported results. For example, positive results or safety and
tolerability in one clinical study provides no assurance that this will be
true in future studies. Neurogen disclaims any intent and does not assume
any obligation to update these forward-looking statements, other than as
may be required under applicable law.
Neurogen Corporation
neurogen
пятница, 27 мая 2011 г.
Local Doctors Trial The Coil To Prevent Womb Cancer, UK
New research in Yorkhill Hospital and Glasgow Royal Infirmary is investigating whether a form of the contraceptive coil can stop women from developing womb cancer.
The Cancer Research UK funded clinical trial - named POET* - is examining whether an intra uterine system (IUS) or coil, that releases a hormone, can prevent cancer of the lining of the womb - endometrial cancer - in high-risk patients.
This particular type of coil, traditionally used for birth control, is inserted into the womb to release the hormone progestagen. One effect of this hormone is to reduce the thickness of the wall of the womb. It is this feature that scientists believe could be the key to reducing the rate of endometrial cancer in women who are at an inherited risk of the disease.
These women who have an inherited a condition called HNPCC** or Lynch syndrome, will be eligible for the trial.
Endometrial cancer is the fifth most common cancer in women in the UK, with most cases being diagnosed after the menopause. While two per cent of British women will develop endometrial cancer, the rate rises to 60 per cent for those women with HNPCC.
Scientists are now recruiting local women from around the Glasgow area aged between 35 and 65, who have HNPCC, to take part in the trial. This is part of a UK-wide trial that aims to recruit 220 women in all and will run for four years.
Each woman on the trial will undergo an examination including an ultrasound scan and biopsy of the womb. If these results are normal then the women will be randomly divided into two groups. One group will receive yearly monitoring, and the other group will receive yearly monitoring and be fitted with a coil called the Mirena IUS.
An annual ultrasound will be carried out in all the women to check for any signs of cancer and a questionnaire will be used to analyse the psychological effects of monitoring and the acceptability of the coil.
Dr Victoria Murday, local researcher at the Yorkhill Hospital, said: "We are uncertain how effective it is to screen for endometrial cancer in women at increased risk of the disease, so prevention is the key.
"Earlier research has provided evidence that Mirena IUS may reduce the risk of endometrial cancer, and we hope that this study can show that it has this effect for women at high risk, who otherwise might opt for hysterectomy."
The research is a collaboration between Queen Mary's University of London, St George's University of London and Cancer Research UK.
Kate Law, Cancer Research UK's clinical trials director, said: "It's vital that we continue to research prevention techniques like the one we are trialing in this study. We need to learn if we can offer those women at high risk of womb cancer more options to help prevent the disease."
For more information about this trial please visit either the POET website or the Cancerhelp UK website. Alternatively, call our specialist nurses on 020 7061 8355.
Notes
*POET - Prevention Of Endometrial Tumours
**Hereditary nonpolyposis colon cancer (HNPCC) is an inherited condition associated with an increased risk for a variety of cancers, especially bowel cancer. This condition is also sometimes called Lynch syndrome. Other than bowel cancer, womb cancer is the most common cancer linked with this syndrome.
Out of every 100 women who carry the HNPCC gene fault, approximately 60 will develop womb cancer at some point in their lives. In this group of women, womb cancer does tend to start at a younger age than in the general population, which can make it more difficult to diagnose because it is more likely to present before the menopause when irregular bleeding may not be noticed.
About 1 in 6 womb cancers in women with the HNPCC gene fault are diagnosed before age 40. If womb cancers in these women can be picked up at an early stage by screening, it is hoped that they have a better chance of being cured, but the effectiveness of screening (by ultrasound or biopsies of the lining of the womb) is still uncertain.
Cancer of the uterus is commonly referred to as 'womb cancer' or 'endometrial cancer'. Each year there are over 6,400 new cases.
Progestagen is a synthetic version of the hormone progesterone.
Centres taking part in this trial: Princess Anne Hospital, Southampton; St George's Hospital, London; Elizabeth Garrett Anderson Hospital, UCL, London; Southend University Hospital, Southend; Basildon University Hospital, Basildon; Addenbrookes Hospital, Cambridge; City Hospital, Birmingham; Liverpool Women's Hospital, Liverpool; St Mary's Hospital, Manchester; Queen Elizabeth Hospital, Gateshead; Yorkhill Hospital/Royal Glasgow Hospital, Glasgow; Belfast City Hospital, Belfast.
Anyone affected by cancer can contact Cancer Research UK's cancer information nurses on 0808 800 4040 (freephone) or visit the charity's patient information website cancerhelp.uk.
About Cancer Research UK
- Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.
- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.
- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.
- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.
- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.
Cancer Research UK
View drug information on Mirena.
The Cancer Research UK funded clinical trial - named POET* - is examining whether an intra uterine system (IUS) or coil, that releases a hormone, can prevent cancer of the lining of the womb - endometrial cancer - in high-risk patients.
This particular type of coil, traditionally used for birth control, is inserted into the womb to release the hormone progestagen. One effect of this hormone is to reduce the thickness of the wall of the womb. It is this feature that scientists believe could be the key to reducing the rate of endometrial cancer in women who are at an inherited risk of the disease.
These women who have an inherited a condition called HNPCC** or Lynch syndrome, will be eligible for the trial.
Endometrial cancer is the fifth most common cancer in women in the UK, with most cases being diagnosed after the menopause. While two per cent of British women will develop endometrial cancer, the rate rises to 60 per cent for those women with HNPCC.
Scientists are now recruiting local women from around the Glasgow area aged between 35 and 65, who have HNPCC, to take part in the trial. This is part of a UK-wide trial that aims to recruit 220 women in all and will run for four years.
Each woman on the trial will undergo an examination including an ultrasound scan and biopsy of the womb. If these results are normal then the women will be randomly divided into two groups. One group will receive yearly monitoring, and the other group will receive yearly monitoring and be fitted with a coil called the Mirena IUS.
An annual ultrasound will be carried out in all the women to check for any signs of cancer and a questionnaire will be used to analyse the psychological effects of monitoring and the acceptability of the coil.
Dr Victoria Murday, local researcher at the Yorkhill Hospital, said: "We are uncertain how effective it is to screen for endometrial cancer in women at increased risk of the disease, so prevention is the key.
"Earlier research has provided evidence that Mirena IUS may reduce the risk of endometrial cancer, and we hope that this study can show that it has this effect for women at high risk, who otherwise might opt for hysterectomy."
The research is a collaboration between Queen Mary's University of London, St George's University of London and Cancer Research UK.
Kate Law, Cancer Research UK's clinical trials director, said: "It's vital that we continue to research prevention techniques like the one we are trialing in this study. We need to learn if we can offer those women at high risk of womb cancer more options to help prevent the disease."
For more information about this trial please visit either the POET website or the Cancerhelp UK website. Alternatively, call our specialist nurses on 020 7061 8355.
Notes
*POET - Prevention Of Endometrial Tumours
**Hereditary nonpolyposis colon cancer (HNPCC) is an inherited condition associated with an increased risk for a variety of cancers, especially bowel cancer. This condition is also sometimes called Lynch syndrome. Other than bowel cancer, womb cancer is the most common cancer linked with this syndrome.
Out of every 100 women who carry the HNPCC gene fault, approximately 60 will develop womb cancer at some point in their lives. In this group of women, womb cancer does tend to start at a younger age than in the general population, which can make it more difficult to diagnose because it is more likely to present before the menopause when irregular bleeding may not be noticed.
About 1 in 6 womb cancers in women with the HNPCC gene fault are diagnosed before age 40. If womb cancers in these women can be picked up at an early stage by screening, it is hoped that they have a better chance of being cured, but the effectiveness of screening (by ultrasound or biopsies of the lining of the womb) is still uncertain.
Cancer of the uterus is commonly referred to as 'womb cancer' or 'endometrial cancer'. Each year there are over 6,400 new cases.
Progestagen is a synthetic version of the hormone progesterone.
Centres taking part in this trial: Princess Anne Hospital, Southampton; St George's Hospital, London; Elizabeth Garrett Anderson Hospital, UCL, London; Southend University Hospital, Southend; Basildon University Hospital, Basildon; Addenbrookes Hospital, Cambridge; City Hospital, Birmingham; Liverpool Women's Hospital, Liverpool; St Mary's Hospital, Manchester; Queen Elizabeth Hospital, Gateshead; Yorkhill Hospital/Royal Glasgow Hospital, Glasgow; Belfast City Hospital, Belfast.
Anyone affected by cancer can contact Cancer Research UK's cancer information nurses on 0808 800 4040 (freephone) or visit the charity's patient information website cancerhelp.uk.
About Cancer Research UK
- Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.
- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.
- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.
- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.
- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.
Cancer Research UK
View drug information on Mirena.
четверг, 26 мая 2011 г.
OctoPlus Proves Efficacy Of OP-145 In Phase II Ear Infection Study
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the drug delivery and development company, announces today that efficacy of OP-145, a novel therapy for the treatment of chronic middle ear infection (otitis media), was demonstrated in an interim analysis of the Phase II study. As a result, OctoPlus will close the study because its goal has been achieved.
An independent Data and Safety Monitoring Board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. This interim analysis shows that treatment with OP-145 is safe and effective, with statistically significant improvement of otoscopic scores. As a result, the DSMB advised OctoPlus to close the study because clinical endpoints were achieved. OctoPlus will follow the recommendation of the Board and close the study at this stage. Complete and final study results are expected to be available by the end of 2008.
Based on these positive results, OctoPlus will proceed with preparations for further development of OP-145 and continue to find commercial partners. In November 2006, OctoPlus granted Green Cross Corporation, a leading pharmaceutical company in the Republic of Korea, an exclusive license to develop and market OP-145 for the Korean market.
The double-blind Phase II clinical trial was started in 2006 and comprises a randomised placebo-controlled study in a maximum of 52 patients suffering from chronic suppurative otitis media, with the option to end the study if interim results were statistically significant. The clinical endpoints of the study were safety and efficacy measured by improvement of otoscopic scores. The interim evaluation was executed as planned in the study protocol, and is based on data from 30 patients, which represents more than half of the planned total patient study group.
"We are very pleased to have obtained proof of efficacy for OP-145," said Joost Holthuis, CEO of OctoPlus. "This further builds the product profile of OP-145 as a new approach in the treatment of infections and puts us in an excellent position to secure a global commercial partner for this product."
About OP-145
OP-145 is a novel peptide product that offers potential benefits to patients with chronic otitis media that do not respond to currently available antibiotics. In addition to chronic middle ear infection, OP-145 shows potential for other indications such as sinusitis and chronic bronchitis.
About OctoPlus
OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled-release versions of known protein therapeutics, other drugs, and vaccines.
Our pipeline consists of 5 products in pre-clinical and clinical development. Our lead product is Locteron, a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical studies. Furthermore, our pipeline comprises a product candidate for the treatment of chronic middle ear infection, which has completed Phase II clinical proof of concept testing, a pre-clinical GLP-1 analogue product candidate for the treatment of diabetes and two pre-clinical-stage single-shot vaccines.
In addition, OctoPlus is a European leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult to formulate active pharmaceutical ingredients. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website octoplus.nl.
This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
OctoPlus
An independent Data and Safety Monitoring Board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. This interim analysis shows that treatment with OP-145 is safe and effective, with statistically significant improvement of otoscopic scores. As a result, the DSMB advised OctoPlus to close the study because clinical endpoints were achieved. OctoPlus will follow the recommendation of the Board and close the study at this stage. Complete and final study results are expected to be available by the end of 2008.
Based on these positive results, OctoPlus will proceed with preparations for further development of OP-145 and continue to find commercial partners. In November 2006, OctoPlus granted Green Cross Corporation, a leading pharmaceutical company in the Republic of Korea, an exclusive license to develop and market OP-145 for the Korean market.
The double-blind Phase II clinical trial was started in 2006 and comprises a randomised placebo-controlled study in a maximum of 52 patients suffering from chronic suppurative otitis media, with the option to end the study if interim results were statistically significant. The clinical endpoints of the study were safety and efficacy measured by improvement of otoscopic scores. The interim evaluation was executed as planned in the study protocol, and is based on data from 30 patients, which represents more than half of the planned total patient study group.
"We are very pleased to have obtained proof of efficacy for OP-145," said Joost Holthuis, CEO of OctoPlus. "This further builds the product profile of OP-145 as a new approach in the treatment of infections and puts us in an excellent position to secure a global commercial partner for this product."
About OP-145
OP-145 is a novel peptide product that offers potential benefits to patients with chronic otitis media that do not respond to currently available antibiotics. In addition to chronic middle ear infection, OP-145 shows potential for other indications such as sinusitis and chronic bronchitis.
About OctoPlus
OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled-release versions of known protein therapeutics, other drugs, and vaccines.
Our pipeline consists of 5 products in pre-clinical and clinical development. Our lead product is Locteron, a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical studies. Furthermore, our pipeline comprises a product candidate for the treatment of chronic middle ear infection, which has completed Phase II clinical proof of concept testing, a pre-clinical GLP-1 analogue product candidate for the treatment of diabetes and two pre-clinical-stage single-shot vaccines.
In addition, OctoPlus is a European leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult to formulate active pharmaceutical ingredients. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website octoplus.nl.
This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
OctoPlus
среда, 25 мая 2011 г.
Complications Of Open Radical Retropubic Prostatectomy In Potential Candidates For Active Monitoring
UroToday - Active monitoring with delayed intervention for prostate cancer (CaP) is an increasingly utilized strategy. However, due to a stage shift migration, men are now diagnosed with much earlier and perhaps more indolent CaP. In the online version of Urology, Dr. Stacy Loeb and associates of Dr. William Catalona evaluate the surgical complications of their patients who underwent radical prostatectomy (RP), but were candidates for active monitoring (AM).
Between 1983 and 2006, 4,265 men underwent RP by Dr. Catalona. The authors identified men from their surgical series that met one of three published sets of criteria for AM: the Patel definition of Gleason score 7 or less and no significant comorbidities, the Choo definition of clinical stage T1b-T2bN0M0, Gleason 7 or less, and a PSA of 15ng/ml or less, or the Mohler definition of clinical stage T1c CaP. They found 3,458, 3,533, and 2,338 men, respectively who met these AM definitions. Oncologic, potency and continence were evaluated longitudinally. Stratified by age, there were 298 men (7%) in their thirties and forties, 1,496 men (35%) in their fifties, 1,934 men (45%) in their sixties, and 536 men (13%) in their 70's or older.
By the Patel criteria, mean preoperative PSA was 7.1ng/ml. The database identified most of the patients as Caucasian with a Gleason score of 6 or less and clinical stage T1c or T2 treated with bilateral nerve sparing surgery. At a mean follow-up of 5 years, 90% were continent, 62% were potent and 7% had surgical complications. By the Choo criteria, mean PSA was 5.9ng/ml and at a mean follow-up of 54 months, 90% were potent, 63% were continent, and 7% had complications. By the Mohler criteria, mean PSA was 6.7ng/ml and at a mean follow-up of 42 months, 90% were continent, 63% were potent, and 5% had surgical complications. The risk of erectile dysfunction increased with increasing age, preoperative PSA, biopsy Gleason score and clinical stage. Medical comorbidities and non nerve-sparing surgery were significantly associated with potency. The risk of surgical complications was directly related to increasing age, PSA and clinical stage, with age the strongest predictor of continence. Men in their forties had continence rates of about 96%, potency rates of 93%, and complication rates of about 4%. Men in their fifties had similar outcomes, but the potency rates were less at 80%. Men in their sixties had continence rates of 94% and potency of up to 69%. Over age 70 men had continence of 70% and potency of 46-59% with a surgical complication rate of up to 13%. These data support excellent outcomes, but some decrease in outcomes with increasing age and a higher complication rate in older patients.
Reported by UroToday Contributing Editor Christopher P. Evans, MD, FACS
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
urotoday
Copyright © 2008 - UroToday
Between 1983 and 2006, 4,265 men underwent RP by Dr. Catalona. The authors identified men from their surgical series that met one of three published sets of criteria for AM: the Patel definition of Gleason score 7 or less and no significant comorbidities, the Choo definition of clinical stage T1b-T2bN0M0, Gleason 7 or less, and a PSA of 15ng/ml or less, or the Mohler definition of clinical stage T1c CaP. They found 3,458, 3,533, and 2,338 men, respectively who met these AM definitions. Oncologic, potency and continence were evaluated longitudinally. Stratified by age, there were 298 men (7%) in their thirties and forties, 1,496 men (35%) in their fifties, 1,934 men (45%) in their sixties, and 536 men (13%) in their 70's or older.
By the Patel criteria, mean preoperative PSA was 7.1ng/ml. The database identified most of the patients as Caucasian with a Gleason score of 6 or less and clinical stage T1c or T2 treated with bilateral nerve sparing surgery. At a mean follow-up of 5 years, 90% were continent, 62% were potent and 7% had surgical complications. By the Choo criteria, mean PSA was 5.9ng/ml and at a mean follow-up of 54 months, 90% were potent, 63% were continent, and 7% had complications. By the Mohler criteria, mean PSA was 6.7ng/ml and at a mean follow-up of 42 months, 90% were continent, 63% were potent, and 5% had surgical complications. The risk of erectile dysfunction increased with increasing age, preoperative PSA, biopsy Gleason score and clinical stage. Medical comorbidities and non nerve-sparing surgery were significantly associated with potency. The risk of surgical complications was directly related to increasing age, PSA and clinical stage, with age the strongest predictor of continence. Men in their forties had continence rates of about 96%, potency rates of 93%, and complication rates of about 4%. Men in their fifties had similar outcomes, but the potency rates were less at 80%. Men in their sixties had continence rates of 94% and potency of up to 69%. Over age 70 men had continence of 70% and potency of 46-59% with a surgical complication rate of up to 13%. These data support excellent outcomes, but some decrease in outcomes with increasing age and a higher complication rate in older patients.
Reported by UroToday Contributing Editor Christopher P. Evans, MD, FACS
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
urotoday
Copyright © 2008 - UroToday
вторник, 24 мая 2011 г.
Oral Mucositis Relieved And Quality-Of-Life Improved for Cancer Patients Using CAPHOSOL
New data show that CAPHOSOL® (caphosol/), an advanced electrolyte solution, relieves painful oral mucositis (OM) and improves quality of life for cancer patients undergoing chemotherapy and radiation therapy. These data were reported in two separate presentations at the 33rd Annual Congress of the Oncology Nursing Society (ONS). These data confirm that CAPHOSOL is a useful tool to help oncology nurses and other healthcare professionals in the management of OM and related symptoms, particularly in patients with head and neck cancer and those receiving chemotherapy.
One of the two abstracts including this data, ONS Abstract #2757, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients" (Haas, ML), was selected by an ONS Expert Panel as one of the Top Ten Best Supportive Care abstracts at the ONS 2008 Congress.
"Oral mucositis is a painful, common side effect experienced by cancer patients receiving chemotherapy and radiation therapy," commented principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Mountain Radiation Oncology, Asheville, N.C. "As layers of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) are eroded during therapy, patients often experience severe pain, are more prone to infection and have difficulty eating and swallowing. Our research concludes that CAPHOSOL, a supersaturated electrolyte oral rinse, should be introduced early in the course of cancer therapy for patients at high risk of oral mucositis because it minimizes the onset and severity of symptoms."
The rate of severe oral mucositis (NCI Clinical OM Grade 3-4) reported by head and neck cancer patients using CAPHOSOL in this study was 11% (Grade 3) and 2% (Grade 4). Historically, the incidence of severe OM in head and neck cancer patients receiving radiation typically ranges from 34% - 56%, depending upon the specific type of treatment.
Relief of Painful Oral Mucositis
Oncologists at 26 sites enrolled 217 patients into this open-label, non-randomized observational study, called the Caphosol Oral Mucositis Follow-up Observational Registry Trial (COMFORT). Patients must have been undergoing chemotherapy and radiation and at high risk of developing OM. Thirty-one percent of the patients had head and neck cancer (HNC), 31 percent had breast cancer, 13 percent had colon cancer, eight percent had lung cancer, six percent had lymphoma and 11 percent had other tumor types. All patients in this study received CAPHOSOL, administered as an oral rinse, four to 10 times daily for an average of six to eight weeks beginning the first day of treatment. Data were reported for 171 of these patients who had completed folow up at the time the data were analyzed for this interim report.
The study showed that 95 percent of the patients reported favorable OM scores as measured by the percentages of patients indicating Grade 0 (no adverse effects or within normal limits), Grade 1 (mild) or Grade 2 (moderate) symptom severity.
The National Cancer Institute (NCI) clinical rating for OM (oral mucositis assessed during a clinical evaluation) of Grade 0 was evident in 61 percent of patients and Grade 1 clinical OM was seen in 20 percent. An NCI functional rating of OM (reflective of how OM affects diet, swallowing, gastrointestinal function and quality of life) of Grades 0 and 1 were reported in 81 percent of patients. Sixty-five percent of patients ranked their dysphagia symptoms (difficulty swallowing) as Grade 0, while 15 percent rated their symptoms as Grade 1. Grade 0 pain was reported by 61 percent of patients and 20 percent assessed their pain as Grade 1.
Out of 112 patients undergoing chemotherapy alone, 78 percent indicated a clinical OM rating of Grade 0 and 79 percent indicated a functional OM rating of Grade 0. Moreover, 23 percent of the 56 patients undergoing radiation therapy alone or in combination with chemotherapy (RT ?± chemo) indicated a clinical OM rating of Grade 0, and 34 percent indicated a functional OM rating of Grade 0. With regard to pain 79 percent of patients undergoing chemotherapy alone and 25 percent of RT ?± chemo-treated patients rated their pain as Grade 0. For dysphagia, eighty-two percent of chemotherapy-treated patients and 30 percent of those undergoing RT ?± chemo treatment reported a dysphagia Grade of 0.
These data confirm that early intervention with Caphosol reduces the occurrence and severity OM, dysphagia and oral pain in patients undergoing chemotherapy, radiation or combination therapy treatments for cancer.
Quality-of-Life Benefits in Patients with Head/Neck Cancer
Oral mucositis occurs in nearly all chemoradiation patients with HNC. Dr. Haas presented a subset analysis of data from 67 HNC patients from the study described above. She presented these data in a poster (#446) entitled, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients." These data confirm high levels of patient and practitioner satisfaction with CAPHOSOL, suggestive of quality-of-life benefits. The poster reports that more than half (52 percent) of the HNC patients said they were "very satisfied" with CAPHOSOL in terms of pain relief and oral comfort. None of the HNC patients reported being unsatisfied with CAPHOSOL.
This study showed that among practitioners treating HNC patients, 16 percent of practitioners reported no signs of OM in their patients at the end of the study, and 70 percent assigned an "excellent or good" rating to CAPHOSOL because none of their patients required additional therapies. Ninety-six percent of the patients indicated they would recommend CAPHOSOL to other patients at high risk of OM.
"Considering that most patients with head and neck cancer experience oral mucositis, any improvements in quality of life for these patients is encouraging," said Dr. Haas. "CAPHOSOL is useful for oncology nurses and other healthcare practitioners in helping patients with oral pain and related symptoms of chemoradiation-induced oral mucositis."
Oral Mucositis: A Common and Debilitating Condition
Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. OM is estimated to affect more than 400,000 cancer patients each year. OM affects approximately 40 percent of cancer patients who receive chemotherapy, more than 70 percent of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.
Oral mucositis usually manifests itself within seven to 14 days after initiation of therapy. Initial signs and symptoms include redness, swelling and ulceration of the mucosa. Oral mucositis can cause mouth pain, xerostomia (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly impact a patient's weight, mood and physical functioning. Severe ulceration may cause breaks in the mucosa, which can then become susceptible to oral opportunistic infections, possibly resulting in bacteremia (the presence of bacteria in the blood), sepsis (the presence of pathogenic microorganisms in the blood) or other potentially fatal complications. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy.
About CAPHOSOL
CAPHOSOL is an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. CAPHOSOL, a U.S. patented prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Patients restricted to a low sodium diet should consult their physician before use. Patients should avoid eating or drinking at least 15 minutes after use.
As part of its commitment to advancing the treatment and care of cancer patients, Cytogen launched CARE OM™ (careom/) a Web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM can also download an OM brochure or request it by mail. For more information about CAPHOSOL, visit caphosol/.
About EUSA Pharma Inc.
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has nine products on the global market, including Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, ProstaScint® for imaging the extent and spread of prostate cancer, Quadramet® for the treatment of pain in patients whose cancer has spread to the bones, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, the antibiotic surgical implant Collatamp® G, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.
Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $275 million, and completed several significant transactions, including the acquisitions of Cytogen Corporation, Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.
For more information please visit eusapharma/.
One of the two abstracts including this data, ONS Abstract #2757, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients" (Haas, ML), was selected by an ONS Expert Panel as one of the Top Ten Best Supportive Care abstracts at the ONS 2008 Congress.
"Oral mucositis is a painful, common side effect experienced by cancer patients receiving chemotherapy and radiation therapy," commented principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Mountain Radiation Oncology, Asheville, N.C. "As layers of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) are eroded during therapy, patients often experience severe pain, are more prone to infection and have difficulty eating and swallowing. Our research concludes that CAPHOSOL, a supersaturated electrolyte oral rinse, should be introduced early in the course of cancer therapy for patients at high risk of oral mucositis because it minimizes the onset and severity of symptoms."
The rate of severe oral mucositis (NCI Clinical OM Grade 3-4) reported by head and neck cancer patients using CAPHOSOL in this study was 11% (Grade 3) and 2% (Grade 4). Historically, the incidence of severe OM in head and neck cancer patients receiving radiation typically ranges from 34% - 56%, depending upon the specific type of treatment.
Relief of Painful Oral Mucositis
Oncologists at 26 sites enrolled 217 patients into this open-label, non-randomized observational study, called the Caphosol Oral Mucositis Follow-up Observational Registry Trial (COMFORT). Patients must have been undergoing chemotherapy and radiation and at high risk of developing OM. Thirty-one percent of the patients had head and neck cancer (HNC), 31 percent had breast cancer, 13 percent had colon cancer, eight percent had lung cancer, six percent had lymphoma and 11 percent had other tumor types. All patients in this study received CAPHOSOL, administered as an oral rinse, four to 10 times daily for an average of six to eight weeks beginning the first day of treatment. Data were reported for 171 of these patients who had completed folow up at the time the data were analyzed for this interim report.
The study showed that 95 percent of the patients reported favorable OM scores as measured by the percentages of patients indicating Grade 0 (no adverse effects or within normal limits), Grade 1 (mild) or Grade 2 (moderate) symptom severity.
The National Cancer Institute (NCI) clinical rating for OM (oral mucositis assessed during a clinical evaluation) of Grade 0 was evident in 61 percent of patients and Grade 1 clinical OM was seen in 20 percent. An NCI functional rating of OM (reflective of how OM affects diet, swallowing, gastrointestinal function and quality of life) of Grades 0 and 1 were reported in 81 percent of patients. Sixty-five percent of patients ranked their dysphagia symptoms (difficulty swallowing) as Grade 0, while 15 percent rated their symptoms as Grade 1. Grade 0 pain was reported by 61 percent of patients and 20 percent assessed their pain as Grade 1.
Out of 112 patients undergoing chemotherapy alone, 78 percent indicated a clinical OM rating of Grade 0 and 79 percent indicated a functional OM rating of Grade 0. Moreover, 23 percent of the 56 patients undergoing radiation therapy alone or in combination with chemotherapy (RT ?± chemo) indicated a clinical OM rating of Grade 0, and 34 percent indicated a functional OM rating of Grade 0. With regard to pain 79 percent of patients undergoing chemotherapy alone and 25 percent of RT ?± chemo-treated patients rated their pain as Grade 0. For dysphagia, eighty-two percent of chemotherapy-treated patients and 30 percent of those undergoing RT ?± chemo treatment reported a dysphagia Grade of 0.
These data confirm that early intervention with Caphosol reduces the occurrence and severity OM, dysphagia and oral pain in patients undergoing chemotherapy, radiation or combination therapy treatments for cancer.
Quality-of-Life Benefits in Patients with Head/Neck Cancer
Oral mucositis occurs in nearly all chemoradiation patients with HNC. Dr. Haas presented a subset analysis of data from 67 HNC patients from the study described above. She presented these data in a poster (#446) entitled, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients." These data confirm high levels of patient and practitioner satisfaction with CAPHOSOL, suggestive of quality-of-life benefits. The poster reports that more than half (52 percent) of the HNC patients said they were "very satisfied" with CAPHOSOL in terms of pain relief and oral comfort. None of the HNC patients reported being unsatisfied with CAPHOSOL.
This study showed that among practitioners treating HNC patients, 16 percent of practitioners reported no signs of OM in their patients at the end of the study, and 70 percent assigned an "excellent or good" rating to CAPHOSOL because none of their patients required additional therapies. Ninety-six percent of the patients indicated they would recommend CAPHOSOL to other patients at high risk of OM.
"Considering that most patients with head and neck cancer experience oral mucositis, any improvements in quality of life for these patients is encouraging," said Dr. Haas. "CAPHOSOL is useful for oncology nurses and other healthcare practitioners in helping patients with oral pain and related symptoms of chemoradiation-induced oral mucositis."
Oral Mucositis: A Common and Debilitating Condition
Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. OM is estimated to affect more than 400,000 cancer patients each year. OM affects approximately 40 percent of cancer patients who receive chemotherapy, more than 70 percent of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.
Oral mucositis usually manifests itself within seven to 14 days after initiation of therapy. Initial signs and symptoms include redness, swelling and ulceration of the mucosa. Oral mucositis can cause mouth pain, xerostomia (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly impact a patient's weight, mood and physical functioning. Severe ulceration may cause breaks in the mucosa, which can then become susceptible to oral opportunistic infections, possibly resulting in bacteremia (the presence of bacteria in the blood), sepsis (the presence of pathogenic microorganisms in the blood) or other potentially fatal complications. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy.
About CAPHOSOL
CAPHOSOL is an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. CAPHOSOL, a U.S. patented prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Patients restricted to a low sodium diet should consult their physician before use. Patients should avoid eating or drinking at least 15 minutes after use.
As part of its commitment to advancing the treatment and care of cancer patients, Cytogen launched CARE OM™ (careom/) a Web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM can also download an OM brochure or request it by mail. For more information about CAPHOSOL, visit caphosol/.
About EUSA Pharma Inc.
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has nine products on the global market, including Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, ProstaScint® for imaging the extent and spread of prostate cancer, Quadramet® for the treatment of pain in patients whose cancer has spread to the bones, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, the antibiotic surgical implant Collatamp® G, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.
Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $275 million, and completed several significant transactions, including the acquisitions of Cytogen Corporation, Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.
For more information please visit eusapharma/.
понедельник, 23 мая 2011 г.
Soliris(R) Therapy Provided Clinical Improvements In PNH Patients Regardless Of Disease Severity
Soliris(R)
(eculizumab) therapy reduced hemolysis, fatigue, thromboses (blood clots)
and transfusion requirements in patients with a rare blood disorder called
paroxysmal nocturnal hemoglobinuria (PNH), including those who might have
been expected to have less severe disease, according to data from an
ongoing open-label clinical study presented at the 49th Annual
Meeting of the American Society of Hematology Meeting in Atlanta.
The data were highlighted in an oral presentation titled, "High
Incidence of Progression to Significant Disease Burden in Paroxysmal
Nocturnal Hemoglobinuria Patients with Lower Levels of Hemolysis, Mild
Anemia and Minimal Transfusion: Clinical Improvement with Eculizumab
Therapy."
In the study, (1) Soliris was associated with significant long-term
clinical improvements in patients with PNH, regardless of baseline degree
of hemolysis, anemia or transfusion requirements. The study also
demonstrated that patients who might have been expected to have less severe
disease, considering their baseline clinical characteristics, suffered from
significant disease burden.
"PNH patients once thought to have less severe disease based on their
clinical characteristics actually face significant disease burden from
anemia, fatigue, impaired quality of life, blood transfusion requirements
and blood clot risk," said Monica Bessler, MD, PhD, lead author of the
study and Professor of Medicine, Professor of Pharmacology and Molecular
Biology, Washington University in St. Louis School of Medicine. "The
results presented today show that, in this study group, regardless of
disease severity, long- term Soliris treatment provides important clinical
improvements in their disease signs, symptoms and complications."
"We continue to observe that the PNH patient population includes a wide
range of patients with a broad clinical profile," said Leonard Bell, MD,
Chief Executive Officer of Alexion Pharmaceuticals. "The results presented
today provide further evidence for the utility of Soliris therapy in
patients with diverse manifestations of PNH. We remain committed to our
goal that all patients who can benefit from Soliris will have access to
it."
Soliris, developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), is
the first therapy approved for the treatment of patients with PNH, a rare,
debilitating and life-threatening blood disorder defined by the destruction
of red blood cells, or hemolysis. Soliris is a complement inhibitor
indicated for the treatment of patients with PNH to reduce hemolysis. In
patients with PNH, hemolysis can cause thromboses, kidney disease, liver
dysfunction, disabling fatigue, impaired quality of life, recurrent pain,
shortness of breath, pulmonary hypertension, intermittent episodes of dark
colored urine (hemoglobinuria), and anemia. (2-4)
Clinical Data
In the ongoing open-label clinical study, investigators examined the
long- term clinical effect of Soliris in patient subgroups, including those
with lower levels of hemolysis, mild anemia and minimal transfusion
requirements.
Data were analyzed by levels of baseline hemolysis (as indicated by
baseline quartiles of lactate dehydrogenase, LDH), anemia (Hgb < 10.5 g/L
vs greater than or equal to 10.5 g/L), and transfusion requirements
(transfusion episodes in prior year greater than 1 vs 1 or 0 episodes).
Hemolysis, fatigue and transfusion requirements were examined using a
ranking test to measure efficacy during both the first and the most recent
six months of Soliris therapy; patients received a median of 22 months of
treatment.
Hemolysis was significantly reduced with eculizumab treatment in
patients with all levels of baseline hemolysis. In patients with the lowest
quartile of hemolysis (< 1490 U/L), LDH was reduced from 1077 +/- 42 U/L
pre-eculizumab to 323 +/- 22 U/L during the first six months and to 347 +/-
47 U/L during the most recent six months of Soliris therapy (P
(eculizumab) therapy reduced hemolysis, fatigue, thromboses (blood clots)
and transfusion requirements in patients with a rare blood disorder called
paroxysmal nocturnal hemoglobinuria (PNH), including those who might have
been expected to have less severe disease, according to data from an
ongoing open-label clinical study presented at the 49th Annual
Meeting of the American Society of Hematology Meeting in Atlanta.
The data were highlighted in an oral presentation titled, "High
Incidence of Progression to Significant Disease Burden in Paroxysmal
Nocturnal Hemoglobinuria Patients with Lower Levels of Hemolysis, Mild
Anemia and Minimal Transfusion: Clinical Improvement with Eculizumab
Therapy."
In the study, (1) Soliris was associated with significant long-term
clinical improvements in patients with PNH, regardless of baseline degree
of hemolysis, anemia or transfusion requirements. The study also
demonstrated that patients who might have been expected to have less severe
disease, considering their baseline clinical characteristics, suffered from
significant disease burden.
"PNH patients once thought to have less severe disease based on their
clinical characteristics actually face significant disease burden from
anemia, fatigue, impaired quality of life, blood transfusion requirements
and blood clot risk," said Monica Bessler, MD, PhD, lead author of the
study and Professor of Medicine, Professor of Pharmacology and Molecular
Biology, Washington University in St. Louis School of Medicine. "The
results presented today show that, in this study group, regardless of
disease severity, long- term Soliris treatment provides important clinical
improvements in their disease signs, symptoms and complications."
"We continue to observe that the PNH patient population includes a wide
range of patients with a broad clinical profile," said Leonard Bell, MD,
Chief Executive Officer of Alexion Pharmaceuticals. "The results presented
today provide further evidence for the utility of Soliris therapy in
patients with diverse manifestations of PNH. We remain committed to our
goal that all patients who can benefit from Soliris will have access to
it."
Soliris, developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), is
the first therapy approved for the treatment of patients with PNH, a rare,
debilitating and life-threatening blood disorder defined by the destruction
of red blood cells, or hemolysis. Soliris is a complement inhibitor
indicated for the treatment of patients with PNH to reduce hemolysis. In
patients with PNH, hemolysis can cause thromboses, kidney disease, liver
dysfunction, disabling fatigue, impaired quality of life, recurrent pain,
shortness of breath, pulmonary hypertension, intermittent episodes of dark
colored urine (hemoglobinuria), and anemia. (2-4)
Clinical Data
In the ongoing open-label clinical study, investigators examined the
long- term clinical effect of Soliris in patient subgroups, including those
with lower levels of hemolysis, mild anemia and minimal transfusion
requirements.
Data were analyzed by levels of baseline hemolysis (as indicated by
baseline quartiles of lactate dehydrogenase, LDH), anemia (Hgb < 10.5 g/L
vs greater than or equal to 10.5 g/L), and transfusion requirements
(transfusion episodes in prior year greater than 1 vs 1 or 0 episodes).
Hemolysis, fatigue and transfusion requirements were examined using a
ranking test to measure efficacy during both the first and the most recent
six months of Soliris therapy; patients received a median of 22 months of
treatment.
Hemolysis was significantly reduced with eculizumab treatment in
patients with all levels of baseline hemolysis. In patients with the lowest
quartile of hemolysis (< 1490 U/L), LDH was reduced from 1077 +/- 42 U/L
pre-eculizumab to 323 +/- 22 U/L during the first six months and to 347 +/-
47 U/L during the most recent six months of Soliris therapy (P
воскресенье, 22 мая 2011 г.
Toxic Trio Identified As The Basis Of Celiac Disease
Walter and Eliza Hall Institute scientists have identified the three protein fragments that make gluten - the main protein in wheat, rye and barley - toxic to people with coeliac disease.
Their discovery opens the way for a new generation of diagnostics, treatments, prevention strategies and food tests for the millions of people worldwide with coeliac disease.
When people with coeliac disease eat products containing gluten their body's immune response is switched on and the lining of the small intestine is damaged, hampering their ability to absorb nutrients. The disease is currently treated by permanently removing gluten from the patient's diet.
Dr Bob Anderson, head of the Walter and Eliza Hall Institute's coeliac disease research laboratory, said it had been 60 years since gluten was discovered to be the environmental cause of coeliac disease.
"In the years since, the holy grail in coeliac disease research has been to identify the toxic peptide components of gluten; and that's what we've done," Dr Anderson said.
The research, done in collaboration with Dr Jason Tye-Din, Dr James Dromey, Dr Stuart Mannering, Dr Jessica Stewart and Dr Tim Beissbarth from the institute as well as Professor Jamie Rossjohn at Monash University and Professor Jim McCluskey at the University of Melbourne, is published in the international journal Science Translational Medicine.
The study was started by Professor Anderson nine years ago and has involved researchers in Australia and the UK as well as more than 200 coeliac disease patients.
The patients, recruited through the Coeliac Society of Victoria and the Coeliac Clinic at John Radcliffe Hospital, UK, ate bread, rye muffins or boiled barley. Six days later, blood samples were taken to measure the strength of the patients' immune responses to 2700 different gluten fragments. The responses identified 90 fragments as causing some level of immune reaction, but three gluten fragments (peptides) were revealed as being particularly toxic.
"These three components account for the majority of the immune response to gluten that is observed in people with coeliac disease," Dr Anderson said.
This knowledge has already been used by Melbourne-based biotech company, Nexpep Pty Ltd, to develop a 'peptide-based' immunotherapy that aims to desensitise people with coeliac disease to the toxic effects of gluten. Nexpep's Phase 1 trials of the therapy were completed in June and final results are expected in coming months.
The immunotherapy works by exposing people with coeliac disease to small amounts of the three toxic peptides and is based upon the same principles as desensitisation for allergies.
Dr Anderson said although coeliac disease could be managed with a gluten-free diet, compliance with the diet is often challenging and nearly half the people on the diet still have residual damage to their small intestine. "Consequently, the immunotherapy and three other drugs are under development to help people with coeliac disease."
The research was supported by the National Health and Medical Research Council, Coeliac UK, the Coeliac Research Fund, Nexpep Pty Ltd, BTG International and the Victorian Government.
Their discovery opens the way for a new generation of diagnostics, treatments, prevention strategies and food tests for the millions of people worldwide with coeliac disease.
When people with coeliac disease eat products containing gluten their body's immune response is switched on and the lining of the small intestine is damaged, hampering their ability to absorb nutrients. The disease is currently treated by permanently removing gluten from the patient's diet.
Dr Bob Anderson, head of the Walter and Eliza Hall Institute's coeliac disease research laboratory, said it had been 60 years since gluten was discovered to be the environmental cause of coeliac disease.
"In the years since, the holy grail in coeliac disease research has been to identify the toxic peptide components of gluten; and that's what we've done," Dr Anderson said.
The research, done in collaboration with Dr Jason Tye-Din, Dr James Dromey, Dr Stuart Mannering, Dr Jessica Stewart and Dr Tim Beissbarth from the institute as well as Professor Jamie Rossjohn at Monash University and Professor Jim McCluskey at the University of Melbourne, is published in the international journal Science Translational Medicine.
The study was started by Professor Anderson nine years ago and has involved researchers in Australia and the UK as well as more than 200 coeliac disease patients.
The patients, recruited through the Coeliac Society of Victoria and the Coeliac Clinic at John Radcliffe Hospital, UK, ate bread, rye muffins or boiled barley. Six days later, blood samples were taken to measure the strength of the patients' immune responses to 2700 different gluten fragments. The responses identified 90 fragments as causing some level of immune reaction, but three gluten fragments (peptides) were revealed as being particularly toxic.
"These three components account for the majority of the immune response to gluten that is observed in people with coeliac disease," Dr Anderson said.
This knowledge has already been used by Melbourne-based biotech company, Nexpep Pty Ltd, to develop a 'peptide-based' immunotherapy that aims to desensitise people with coeliac disease to the toxic effects of gluten. Nexpep's Phase 1 trials of the therapy were completed in June and final results are expected in coming months.
The immunotherapy works by exposing people with coeliac disease to small amounts of the three toxic peptides and is based upon the same principles as desensitisation for allergies.
Dr Anderson said although coeliac disease could be managed with a gluten-free diet, compliance with the diet is often challenging and nearly half the people on the diet still have residual damage to their small intestine. "Consequently, the immunotherapy and three other drugs are under development to help people with coeliac disease."
The research was supported by the National Health and Medical Research Council, Coeliac UK, the Coeliac Research Fund, Nexpep Pty Ltd, BTG International and the Victorian Government.
пятница, 20 мая 2011 г.
First Targeted Therapy To Produce Remission Of Metastatic Melanoma Described In Report
In a demonstration that even some of the most hard-to-treat tumors may one day succumb to therapies aimed at molecular "weak points," researchers at Dana-Farber Cancer Institute report the first instance in which metastatic melanoma has been driven into remission by a targeted therapy.
The report, published in the April 20 issue of the Journal of Clinical Oncology, describes the case of a 79-year-old woman with melanoma tumors in several parts of her abdomen. When lab tests showed the tumor cells carried an abnormality in a gene called KIT, the patient enrolled in a clinical trial involving Gleevec (R) (Imatinib), a drug known to target that gene.
Four weeks after beginning therapy, imaging exams showed a dramatic reduction in tumor size and metabolism: two of the tumor masses had disappeared and several others had shrunken considerably. Four months later, the tumors were still in check, and today, nine months after the start of therapy, she continues to take the drug and her condition remains stable.
"This is the first proof of principle that we can find an Achilles' heel in melanoma" -- a gene critical to tumor cell growth and proliferation -- "and, by targeting that gene with a drug, cause the cell to die," says the study's lead author, Stephen Hodi, MD, of Dana-Farber. "It is especially exciting because there haven't been any effective treatments for melanoma patients with metastatic disease."
Although the report involves just one patient, it should inject new confidence in the fight against melanoma, Hodi says. Because previous research has failed to find any genetic Achilles' heels capable of shutting down melanoma cell growth, some researchers had speculated that none may exist for such cells. The discovery of one suggests there may be others.
KIT mutations are found in only a small percentage of melanomas, so Imatinib does not represent a universal treatment for the disease, Hodi explains. Recent studies have found KIT mutations in 11 percent of acral melanomas (which arise in skin without hair follicles, such as that of the palms, foot soles, and nail beds, and account for 5 percent of all melanomas), 21 percent of mucosal melanomas (which arise in the mucous membranes of some organs), and 17 percent of melanomas arising in chronically sun-damaged skin. For patients with these conditions, particularly those who carry a mutation in a particular section of the gene, Imatinib may well prove beneficial.
Imatinib's effectiveness against tumors with KIT mutations was first demonstrated in gastrointestinal stromal tumors (GISTs), a relatively rare malignancy of the digestive tract. An estimated 75-80 percent of GISTs have KIT mutations, and Imatinib has caused such tumors to stabilize or retreat in 75-90 percent of patients receiving it. In most of these patients, however, tumors eventually begin growing again as they become resistant to the drug.
The KIT mutation in the patient described in the study involved a protein-coding section of the gene where DNA was duplicated. This section, known as the "juxtamembrane domain," is the most frequent site of mutation in GIST, and is associated with a strong tumor response to Imatinib.
"Dramatic remissions in metastatic melanoma are something that, as physicians, we've rarely seen," Hodi remarks. "Confirming these results will require enrolling additional patients in clinical trials -- something we're actively working to accomplish."
The senior author of the study is David E. Fisher, MD, PhD, who participated in the research as a Dana-Farber faculty member and is now at Massachusetts General Hospital. Other co-authors include Philip Friedlander, MD, PhD, Annick D. Van den Abbeele, MD, George Demetri, MD, Suzanne Mac Rae, MPH, Andrea Kruse, and Jyothi Jagannathan, MD, of Dana-Farber; Christopher Corless, MD, PhD, and Michael Heinrich, MD, of Oregon Health & Science University; and Elsa Velazquez, MD, of Brigham and Women's Hospital.
Funding for the research was provided in part by the Ron Gelb Melanoma Research Fund at Dana-Farber.
Dana-Farber Cancer Institute (danafarber/) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.
The report, published in the April 20 issue of the Journal of Clinical Oncology, describes the case of a 79-year-old woman with melanoma tumors in several parts of her abdomen. When lab tests showed the tumor cells carried an abnormality in a gene called KIT, the patient enrolled in a clinical trial involving Gleevec (R) (Imatinib), a drug known to target that gene.
Four weeks after beginning therapy, imaging exams showed a dramatic reduction in tumor size and metabolism: two of the tumor masses had disappeared and several others had shrunken considerably. Four months later, the tumors were still in check, and today, nine months after the start of therapy, she continues to take the drug and her condition remains stable.
"This is the first proof of principle that we can find an Achilles' heel in melanoma" -- a gene critical to tumor cell growth and proliferation -- "and, by targeting that gene with a drug, cause the cell to die," says the study's lead author, Stephen Hodi, MD, of Dana-Farber. "It is especially exciting because there haven't been any effective treatments for melanoma patients with metastatic disease."
Although the report involves just one patient, it should inject new confidence in the fight against melanoma, Hodi says. Because previous research has failed to find any genetic Achilles' heels capable of shutting down melanoma cell growth, some researchers had speculated that none may exist for such cells. The discovery of one suggests there may be others.
KIT mutations are found in only a small percentage of melanomas, so Imatinib does not represent a universal treatment for the disease, Hodi explains. Recent studies have found KIT mutations in 11 percent of acral melanomas (which arise in skin without hair follicles, such as that of the palms, foot soles, and nail beds, and account for 5 percent of all melanomas), 21 percent of mucosal melanomas (which arise in the mucous membranes of some organs), and 17 percent of melanomas arising in chronically sun-damaged skin. For patients with these conditions, particularly those who carry a mutation in a particular section of the gene, Imatinib may well prove beneficial.
Imatinib's effectiveness against tumors with KIT mutations was first demonstrated in gastrointestinal stromal tumors (GISTs), a relatively rare malignancy of the digestive tract. An estimated 75-80 percent of GISTs have KIT mutations, and Imatinib has caused such tumors to stabilize or retreat in 75-90 percent of patients receiving it. In most of these patients, however, tumors eventually begin growing again as they become resistant to the drug.
The KIT mutation in the patient described in the study involved a protein-coding section of the gene where DNA was duplicated. This section, known as the "juxtamembrane domain," is the most frequent site of mutation in GIST, and is associated with a strong tumor response to Imatinib.
"Dramatic remissions in metastatic melanoma are something that, as physicians, we've rarely seen," Hodi remarks. "Confirming these results will require enrolling additional patients in clinical trials -- something we're actively working to accomplish."
The senior author of the study is David E. Fisher, MD, PhD, who participated in the research as a Dana-Farber faculty member and is now at Massachusetts General Hospital. Other co-authors include Philip Friedlander, MD, PhD, Annick D. Van den Abbeele, MD, George Demetri, MD, Suzanne Mac Rae, MPH, Andrea Kruse, and Jyothi Jagannathan, MD, of Dana-Farber; Christopher Corless, MD, PhD, and Michael Heinrich, MD, of Oregon Health & Science University; and Elsa Velazquez, MD, of Brigham and Women's Hospital.
Funding for the research was provided in part by the Ron Gelb Melanoma Research Fund at Dana-Farber.
Dana-Farber Cancer Institute (danafarber/) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.
четверг, 19 мая 2011 г.
Argos Therapeutics' Arcelis™ HIV Immunotherapy Demonstrates Significant Reduction In Viral Load And Delay In Viral Rebound Kinetics
Argos Therapeutics announced that, in an interim analysis of a Phase 2 trial, its Arcelis immunotherapy targeted at HIV, AGS-004, demonstrated a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment interruption (ARTI) when compared to pre-ART viral loads. The data will be presented in an oral poster presentation session. ART represents a major breakthrough for the management of HIV-infected patients, but is not without side effects and is a life-long commitment. Therapeutic immunotherapies to enhance immune response and control viral replication are needed to limit exposure to ART.
Data from an analysis of 22 patients who have completed the 12 weeks ARTI in the ongoing, multicenter Phase 2 trial were presented by Jean-Pierre Routy, M.D., principal investigator of the study at the McGill University Health Centre in Montreal, at the International AIDS Conference (AIDS 2010) in Vienna, Austria. The mean reduction in viral load at week 12 of the ARTI for responders (n=14) compared to the pre-ART sample was 1.30 log. The mean time to detectable viral rebound during the ARTI was delayed compared to previous studies (2 weeks vs 3.77 weeks) and the median time to peak viral load during the ARTI was also delayed (8 weeks). Patients were able to remain safely off ART for a median time of 17.2 weeks and an average of 25.1 weeks. Importantly, the patients who completed the 12 week ARTI did not exhibit a significant decline in CD4 cell counts. The treatment was well tolerated with no significant adverse events related to AGS-004 reported.
In a second poster presentation, Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development for Argos, presented an analysis of immune responses induced by AGS-004 and their relationship to viral load control. The immune monitoring data demonstrated a correlation between the induction of effector memory CD8+ T cells and viral load control and underscored the importance of avoiding activation of CD4+ T cells, a unique property of AGS-004.
"The updated results from this study demonstrate that AGS-004 is well tolerated, immunogenic, potentially efficacious and safe," said Dr. Routy. "We are encouraged that the upcoming, double-blind, placebo controlled, randomized Phase 2b study co-funded by the NIH may further show that this personalized immunotherapy is feasible for the treatment of HIV-1 infected patients."
Jeffrey Abbey, President and Chief Executive Officer of Argos, added, "Our unique and broadly applicable approach to personalized immunotherapy has demonstrated the ability to produce measurable immune responses against HIV and forms of cancer, including renal cell carcinoma as demonstrated by recently presented data from a Phase 2 study of AGS-003. Coupled with the automation of our manufacturing process, we believe that our Arcelis platform can yield promising treatments for patients that can be complimentary adjuncts to current drug therapy."
About the Arcelis™ Technology
Arcelis is Argos' proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, cancer and other infectious diseases. This platform is based on optimizing a patient's own (autologous) dendritic cells to trigger a pathogen- or tumor-specific immune response. To address the challenge of the unique genetic profile of each patient's disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA ("mRNA") isolated from the patient's disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is customized to the patient's specific disease.
About Argos Therapeutics, Inc.
Argos is an immunotherapy company developing new treatments for cancer, infectious and autoimmune diseases and transplantation rejection. The Company has generated multiple platform technologies and a diverse pipeline of products based on its expertise in the biology of dendritic cells the master switch that turns the immune system on or off.
Data from an analysis of 22 patients who have completed the 12 weeks ARTI in the ongoing, multicenter Phase 2 trial were presented by Jean-Pierre Routy, M.D., principal investigator of the study at the McGill University Health Centre in Montreal, at the International AIDS Conference (AIDS 2010) in Vienna, Austria. The mean reduction in viral load at week 12 of the ARTI for responders (n=14) compared to the pre-ART sample was 1.30 log. The mean time to detectable viral rebound during the ARTI was delayed compared to previous studies (2 weeks vs 3.77 weeks) and the median time to peak viral load during the ARTI was also delayed (8 weeks). Patients were able to remain safely off ART for a median time of 17.2 weeks and an average of 25.1 weeks. Importantly, the patients who completed the 12 week ARTI did not exhibit a significant decline in CD4 cell counts. The treatment was well tolerated with no significant adverse events related to AGS-004 reported.
In a second poster presentation, Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development for Argos, presented an analysis of immune responses induced by AGS-004 and their relationship to viral load control. The immune monitoring data demonstrated a correlation between the induction of effector memory CD8+ T cells and viral load control and underscored the importance of avoiding activation of CD4+ T cells, a unique property of AGS-004.
"The updated results from this study demonstrate that AGS-004 is well tolerated, immunogenic, potentially efficacious and safe," said Dr. Routy. "We are encouraged that the upcoming, double-blind, placebo controlled, randomized Phase 2b study co-funded by the NIH may further show that this personalized immunotherapy is feasible for the treatment of HIV-1 infected patients."
Jeffrey Abbey, President and Chief Executive Officer of Argos, added, "Our unique and broadly applicable approach to personalized immunotherapy has demonstrated the ability to produce measurable immune responses against HIV and forms of cancer, including renal cell carcinoma as demonstrated by recently presented data from a Phase 2 study of AGS-003. Coupled with the automation of our manufacturing process, we believe that our Arcelis platform can yield promising treatments for patients that can be complimentary adjuncts to current drug therapy."
About the Arcelis™ Technology
Arcelis is Argos' proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, cancer and other infectious diseases. This platform is based on optimizing a patient's own (autologous) dendritic cells to trigger a pathogen- or tumor-specific immune response. To address the challenge of the unique genetic profile of each patient's disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA ("mRNA") isolated from the patient's disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is customized to the patient's specific disease.
About Argos Therapeutics, Inc.
Argos is an immunotherapy company developing new treatments for cancer, infectious and autoimmune diseases and transplantation rejection. The Company has generated multiple platform technologies and a diverse pipeline of products based on its expertise in the biology of dendritic cells the master switch that turns the immune system on or off.
среда, 18 мая 2011 г.
Bayer Schering Pharma Paves The Way To The Next Important Oral Contraceptive Milestone
Bayer Schering Pharma AG, Germany, has submitted for registration the first combined oral contraceptive product based on estradiol and the progestin dienogest to all Member States of the European Community. The Netherlands will serve as the Reference Member State for the Decentralized Procedure to gain European-wide Marketing Authorization.
This new oral contraceptive provides estradiol, the same estrogen produced by the female body. A comparative clinical study showed that this new combination results in a good cycle control, comparable to combined oral contraceptives with 20 ?µg ethinylestradiol. Clinical research also demonstrated that this new oral contraceptive has a less pronounced impact on liver and metabolic parameters compared to the investigated comparators.
"With this submission we demonstrate our commitment as the worldwide market leader in female contraception to develop innovative oral contraceptives with added health benefits for women," said Phil Smits, M.D., Head of Women's Healthcare at Bayer Schering Pharma AG. "Our new product is the first oral contraceptive that is based on a bio-identical estrogen. We are absolutely delighted to be the first to have achieved this important milestone in the development of oral contraceptives."
Bayer Schering Pharma has developed the product as "DUB-OC (E2/DNG)" for oral contraception. It is also being studied for the treatment of prolonged, frequent and excessive bleeding (dysfunctional uterine bleeding), however is only seeking approval for the oral contraception indication at this time. The decision for a brand name is pending.
During the last 50 years several progestins have been developed for the use in oral contraceptives, but basically only one estrogen, namely ethinylestradiol, is currently being used worldwide. Numerous efforts have been made in the past to use estradiol. All these attempts have proven disappointing with regard to cycle control. Use of estradiol was made possible with this new product by the use of dienogest.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at bayerhealthcare.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at bayerscheringpharma.de.
Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
View drug information on Estradiol.
This new oral contraceptive provides estradiol, the same estrogen produced by the female body. A comparative clinical study showed that this new combination results in a good cycle control, comparable to combined oral contraceptives with 20 ?µg ethinylestradiol. Clinical research also demonstrated that this new oral contraceptive has a less pronounced impact on liver and metabolic parameters compared to the investigated comparators.
"With this submission we demonstrate our commitment as the worldwide market leader in female contraception to develop innovative oral contraceptives with added health benefits for women," said Phil Smits, M.D., Head of Women's Healthcare at Bayer Schering Pharma AG. "Our new product is the first oral contraceptive that is based on a bio-identical estrogen. We are absolutely delighted to be the first to have achieved this important milestone in the development of oral contraceptives."
Bayer Schering Pharma has developed the product as "DUB-OC (E2/DNG)" for oral contraception. It is also being studied for the treatment of prolonged, frequent and excessive bleeding (dysfunctional uterine bleeding), however is only seeking approval for the oral contraception indication at this time. The decision for a brand name is pending.
During the last 50 years several progestins have been developed for the use in oral contraceptives, but basically only one estrogen, namely ethinylestradiol, is currently being used worldwide. Numerous efforts have been made in the past to use estradiol. All these attempts have proven disappointing with regard to cycle control. Use of estradiol was made possible with this new product by the use of dienogest.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at bayerhealthcare.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at bayerscheringpharma.de.
Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
View drug information on Estradiol.
вторник, 17 мая 2011 г.
Positive Phase I/II Data Of IDX899 Confirm Potent Antiviral Activity And Favorable Safety Profile In Treatment-Naive HIV-Infected Patients
Idenix
Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged
in the discovery and development of drugs for the treatment of human viral
and other infectious diseases, today reported phase I/II data for IDX899, a
non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for
the treatment of HIV-1. Patients receiving once-daily IDX899 achieved a
mean plasma viral load reduction of approximately 1.8 log(10) after seven
days of treatment in each of the 800 mg, 400 mg and 200 mg dosing cohorts.
Patients receiving placebo had a 0.05 log10 viral load increase over the
same treatment period. No treatment-related serious adverse events were
reported for any of the patients receiving IDX899 and no patients
discontinued the study. Also, there were no discernable patterns in adverse
events between treatment groups and there were no laboratory abnormalities
during the treatment period. These data demonstrate potent antiviral
activity and a favorable safety profile at all tested doses.
"The profound inhibition of HIV-1 virus replication of IDX899 at doses
of 400 and 200 mg daily confirm the potent antiviral activity previously
reported at higher doses," said Dr. Robert Murphy, John P. Phair Professor
of Infectious Diseases, Director, Global Health Research, Feinberg School
of Medicine, Northwestern University. "These early clinical data are very
encouraging, showing that IDX899 offers potent viral suppression combined
with a promising safety profile."
Study Design
The phase I/II clinical trial was designed to evaluate the safety,
tolerability, antiviral activity and pharmacokinetics of IDX899. Three
cohorts of 800 mg/day, 400 mg/day and 200 mg/day were completed with ten
HIV-1- infected treatment-na??ve patients randomized 8:2 in each cohort to
receive orally once-daily IDX899 or matching placebo, respectively, for
seven days. Based on the potent antiviral activity of IDX899 seen to date,
the study was recently amended to also evaluate a lower dose of 100 mg/day.
Study Results
Patients receiving daily oral administration of 800 mg, 400 mg and 200
mg IDX899 achieved mean viral load reductions of 1.78, 1.78, and 1.83
log(10), respectively, after seven days of treatment based on results
determined by the Roche Amplicor(R) 1.5 assay. Patients (n=6) receiving
placebo achieved mean plasma viral load increase of 0.05 log(10).
One key eligibility criterion for enrollment in the study was that
patients' CD4+ count (or T-cell count) had to be greater than or equal to
200 cells/mm3. The mean CD4+ count change from baseline increased by at
least 60 cells/mm3 for each of the 800 mg, 400 mg and 200 mg dosing cohorts
and decreased by about 80 cells/mm3 for patients receiving placebo. No
clear pharmacokinetic/pharmacodynamic relationship was demonstrated, likely
due to drug trough levels well above the EC(90) of IDX899 against wild-type
HIV-1.
"We believe any new HIV treatment must demonstrate potent antiviral
activity at low doses to be suitable for combination therapy and possible
co-formulation with other antiretroviral drugs. We are very encouraged that
the robust antiviral activity observed at 800 mg/day was also achieved by
the 400 and 200 mg/day cohorts," said Douglas Mayers, M.D., Idenix's chief
medical officer. "We look forward to evaluating a 100 mg once-daily IDX899
dose in the upcoming weeks."
Data for patients enrolled in the study will be presented today at the
XVII International HIV Drug Resistance Workshop in Sitges, Spain.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral and other infectious
diseases. Idenix's current focus is on the treatment of infections caused
by hepatitis C virus and HIV. For further information about Idenix, please
refer to idenix
Forward-looking Statements
This press release contains "forward-looking statements" within the
meaning of The Private Securities Litigation Reform Act of 1995. Such
forward-looking statements can be identified by the use of forward-looking
terminology such as "anticipate," "could," "may," "will," or similar
expressions, or by express or implied statements with respect to the
company's clinical development programs in HIV, or any potential pipeline
candidates for the treatment of HIV, including any expressed or implied
statement regarding the efficacy and safety of IDX899 and any future
clinical trials involving IDX899. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements. There
can be no guarantees that the company will advance any clinical product
candidate or other component of its potential pipeline to the clinic, to
the regulatory process or to commercialization. In particular, management's
expectations could be affected by unexpected regulatory actions or delays;
uncertainties relating to, or unsuccessful results of, pre-clinical studies
and/or clinical trials, including additional data relating to the ongoing
pre-clinical studies and/or clinical trials evaluating its product
candidates, including IDX899; the company's ability to obtain additional
funding required to conduct its research, development and commercialization
activities; the company's dependence on its collaboration with Novartis
Pharma AG; changes in the company's business plan or objectives; the
ability of the company to attract and retain qualified personnel;
competition in general; and the company's ability to obtain, maintain and
enforce patent and other intellectual property protection for its product
candidates and its discoveries. These and other risks which may impact
management's expectations are described in greater detail under the caption
"Risk Factors" in the company's annual report on Form 10-K for the year
ended December 31, 2007 and the Quarterly Report on Form 10-Q for the
quarter ended March 31, 2008, each as filed with the Securities and
Exchange Commission (SEC) and other filings that the company makes with the
SEC.
All forward-looking statements reflect the company's expectations only
as of the date of this release and should not be relied upon as reflecting
the company's views, expectations or beliefs at any date subsequent to the
date of this release. Idenix anticipates that subsequent events and
developments may cause these views, expectations and beliefs to change.
However, while Idenix may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to do
so.
Amplicor(R) is a registered trademark of F. Hoffman-La Roche Ltd.
Idenix Pharmaceuticals, Inc.
idenix
Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged
in the discovery and development of drugs for the treatment of human viral
and other infectious diseases, today reported phase I/II data for IDX899, a
non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for
the treatment of HIV-1. Patients receiving once-daily IDX899 achieved a
mean plasma viral load reduction of approximately 1.8 log(10) after seven
days of treatment in each of the 800 mg, 400 mg and 200 mg dosing cohorts.
Patients receiving placebo had a 0.05 log10 viral load increase over the
same treatment period. No treatment-related serious adverse events were
reported for any of the patients receiving IDX899 and no patients
discontinued the study. Also, there were no discernable patterns in adverse
events between treatment groups and there were no laboratory abnormalities
during the treatment period. These data demonstrate potent antiviral
activity and a favorable safety profile at all tested doses.
"The profound inhibition of HIV-1 virus replication of IDX899 at doses
of 400 and 200 mg daily confirm the potent antiviral activity previously
reported at higher doses," said Dr. Robert Murphy, John P. Phair Professor
of Infectious Diseases, Director, Global Health Research, Feinberg School
of Medicine, Northwestern University. "These early clinical data are very
encouraging, showing that IDX899 offers potent viral suppression combined
with a promising safety profile."
Study Design
The phase I/II clinical trial was designed to evaluate the safety,
tolerability, antiviral activity and pharmacokinetics of IDX899. Three
cohorts of 800 mg/day, 400 mg/day and 200 mg/day were completed with ten
HIV-1- infected treatment-na??ve patients randomized 8:2 in each cohort to
receive orally once-daily IDX899 or matching placebo, respectively, for
seven days. Based on the potent antiviral activity of IDX899 seen to date,
the study was recently amended to also evaluate a lower dose of 100 mg/day.
Study Results
Patients receiving daily oral administration of 800 mg, 400 mg and 200
mg IDX899 achieved mean viral load reductions of 1.78, 1.78, and 1.83
log(10), respectively, after seven days of treatment based on results
determined by the Roche Amplicor(R) 1.5 assay. Patients (n=6) receiving
placebo achieved mean plasma viral load increase of 0.05 log(10).
One key eligibility criterion for enrollment in the study was that
patients' CD4+ count (or T-cell count) had to be greater than or equal to
200 cells/mm3. The mean CD4+ count change from baseline increased by at
least 60 cells/mm3 for each of the 800 mg, 400 mg and 200 mg dosing cohorts
and decreased by about 80 cells/mm3 for patients receiving placebo. No
clear pharmacokinetic/pharmacodynamic relationship was demonstrated, likely
due to drug trough levels well above the EC(90) of IDX899 against wild-type
HIV-1.
"We believe any new HIV treatment must demonstrate potent antiviral
activity at low doses to be suitable for combination therapy and possible
co-formulation with other antiretroviral drugs. We are very encouraged that
the robust antiviral activity observed at 800 mg/day was also achieved by
the 400 and 200 mg/day cohorts," said Douglas Mayers, M.D., Idenix's chief
medical officer. "We look forward to evaluating a 100 mg once-daily IDX899
dose in the upcoming weeks."
Data for patients enrolled in the study will be presented today at the
XVII International HIV Drug Resistance Workshop in Sitges, Spain.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral and other infectious
diseases. Idenix's current focus is on the treatment of infections caused
by hepatitis C virus and HIV. For further information about Idenix, please
refer to idenix
Forward-looking Statements
This press release contains "forward-looking statements" within the
meaning of The Private Securities Litigation Reform Act of 1995. Such
forward-looking statements can be identified by the use of forward-looking
terminology such as "anticipate," "could," "may," "will," or similar
expressions, or by express or implied statements with respect to the
company's clinical development programs in HIV, or any potential pipeline
candidates for the treatment of HIV, including any expressed or implied
statement regarding the efficacy and safety of IDX899 and any future
clinical trials involving IDX899. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements. There
can be no guarantees that the company will advance any clinical product
candidate or other component of its potential pipeline to the clinic, to
the regulatory process or to commercialization. In particular, management's
expectations could be affected by unexpected regulatory actions or delays;
uncertainties relating to, or unsuccessful results of, pre-clinical studies
and/or clinical trials, including additional data relating to the ongoing
pre-clinical studies and/or clinical trials evaluating its product
candidates, including IDX899; the company's ability to obtain additional
funding required to conduct its research, development and commercialization
activities; the company's dependence on its collaboration with Novartis
Pharma AG; changes in the company's business plan or objectives; the
ability of the company to attract and retain qualified personnel;
competition in general; and the company's ability to obtain, maintain and
enforce patent and other intellectual property protection for its product
candidates and its discoveries. These and other risks which may impact
management's expectations are described in greater detail under the caption
"Risk Factors" in the company's annual report on Form 10-K for the year
ended December 31, 2007 and the Quarterly Report on Form 10-Q for the
quarter ended March 31, 2008, each as filed with the Securities and
Exchange Commission (SEC) and other filings that the company makes with the
SEC.
All forward-looking statements reflect the company's expectations only
as of the date of this release and should not be relied upon as reflecting
the company's views, expectations or beliefs at any date subsequent to the
date of this release. Idenix anticipates that subsequent events and
developments may cause these views, expectations and beliefs to change.
However, while Idenix may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to do
so.
Amplicor(R) is a registered trademark of F. Hoffman-La Roche Ltd.
Idenix Pharmaceuticals, Inc.
idenix
понедельник, 16 мая 2011 г.
MS Society Of Canada Commits $1 Million For CCSVI Clinical Trial
The Multiple Sclerosis Society of Canada board of directors unanimously approved a motion to reserve $1 million for a chronic cerebrospinal venous insufficiency (CCSVI) and MS pan-Canadian therapeutic clinical trial. The funding will be set aside so that an immediate infusion of funding will be available when such a trial is developed and approved.
"We want to hit the ground running when a therapeutic trial is warranted and approved," says Yves Savoie, president and CEO of the MS Society. "Ensuring funds are available to support a Canadian trial will accelerate our ability to get definitive answers to the questions people touched by MS urgently seek."
The MS Society of Canada hopes to work with the provinces and the federal government to secure all of the funding for a therapeutic clinical trial. At the recent health ministers' meeting in Newfoundland, provinces and territories collectively stated that the issue of CCSVI is a top priority.
"We applaud the spirit of cooperation that the federal, provincial and territorial governments have shown in moving CCSVI to the forefront of the country's health agenda," says Savoie. "The MS Society of Canada is ready to play a central role in preparing for and funding a scientifically rigorous pan-Canadian therapeutic clinical trial to test CCSVI."
The MS Society has advocated for more research since the CCSVI theory became widely publicized in the fall of 2009. Already, $2.4 million has been committed by the MS Society of Canada and the National MS Society (USA) to support seven research projects focusing on CCSVI and its relationship to MS.
Earlier this summer, the Federal Minister of Health accepted the Canadian Institutes of Health Research's recommendation to create an expert scientific working group to monitor the results of the studies already underway. The experts will analyze the evidence about the definition and nature of venous blockages and their relationship with MS, since this information will be central to obtaining ethical approval to enrol participants in a trial.
"The MS Society is committed to doing all that it can to ensure that an eventual trial will be rigorously designed and successfully implemented," concludes Savoie. "We will continue to expedite the research process so that the treatment potential of CCSVI as it relates to MS can be understood as quickly as possible."
"We want to hit the ground running when a therapeutic trial is warranted and approved," says Yves Savoie, president and CEO of the MS Society. "Ensuring funds are available to support a Canadian trial will accelerate our ability to get definitive answers to the questions people touched by MS urgently seek."
The MS Society of Canada hopes to work with the provinces and the federal government to secure all of the funding for a therapeutic clinical trial. At the recent health ministers' meeting in Newfoundland, provinces and territories collectively stated that the issue of CCSVI is a top priority.
"We applaud the spirit of cooperation that the federal, provincial and territorial governments have shown in moving CCSVI to the forefront of the country's health agenda," says Savoie. "The MS Society of Canada is ready to play a central role in preparing for and funding a scientifically rigorous pan-Canadian therapeutic clinical trial to test CCSVI."
The MS Society has advocated for more research since the CCSVI theory became widely publicized in the fall of 2009. Already, $2.4 million has been committed by the MS Society of Canada and the National MS Society (USA) to support seven research projects focusing on CCSVI and its relationship to MS.
Earlier this summer, the Federal Minister of Health accepted the Canadian Institutes of Health Research's recommendation to create an expert scientific working group to monitor the results of the studies already underway. The experts will analyze the evidence about the definition and nature of venous blockages and their relationship with MS, since this information will be central to obtaining ethical approval to enrol participants in a trial.
"The MS Society is committed to doing all that it can to ensure that an eventual trial will be rigorously designed and successfully implemented," concludes Savoie. "We will continue to expedite the research process so that the treatment potential of CCSVI as it relates to MS can be understood as quickly as possible."
воскресенье, 15 мая 2011 г.
Prescient Medical, Inc. Presents Clinical And Preclinical Findings For VProtect(TM) Luminal Shield And VPredict(TM) Optical Catheter System
TCT 2008 attendees will be
among the first to hear a report on initial clinical experiences with the
vProtect(TM) Luminal Shield in patients with non-flow-limiting "vulnerable"
plaques. Professor Patrick Serruys, Director of Clinical Research and chief
of interventional cardiology at the Erasmus Medical Center in Rotterdam,
the Netherlands, will present early findings and describe the rationale and
design of the SECRITT I trial, a randomized pilot study of the device in
patients with vulnerable plaque. According to Prof. Serruys, "Vulnerable
plaques can rupture suddenly, and with catastrophic results. If the
vProtect(TM) Luminal Shield can gently stabilize these plaques, as it is
designed to do, it will be a break-through, a paradigm shift in
interventional cardiology." Prof. Serruys's presentation, "Progress with a
Vulnerable Plaque Shield and a 'Secret' Trial," is scheduled for 4:18 pm,
Monday October 13, in room 152A of the Walter E. Washington Convention
Center, Washington DC.
Its unique self-expanding and biocompatible design makes the
vProtect(TM) Luminal Shield a potentially attractive alternative to
traditional stents in established indications. Juan Granada, MD, will
present details on the innovative design of the vProtect(TM) Luminal Shield
and an update on the ongoing first-in-human study of the Shield at 11:52 am
on Monday October 13, in room 145AB of the Washington Convention Center.
Prescient Medical is also spearheading an effort to better identify and
characterize vulnerable plaques, a project that strongly complements the
vProtect(TM) Luminal Shield development program. Guillermo Tearney, MD,
PhD, of the Wellman Center for Photomedicine, Massachusetts General
Hospital, will present new results related to the use of the vPredict(TM)
Optical Catheter System for characterizing vulnerable plaques at TCT 2008.
The vPredict(TM) platform is based on Raman spectroscopy, a highly
sensitive technique that is used in scores of critical non-clinical
applications. "The vPredict(TM) Optical Catheter System can detect the
spectroscopic 'fingerprints' of compounds in the plaque. Our task is to
correlate the spectra we obtain to histology, so that we can classify a
plaque, and ultimately assess its risk of rupture in vivo, based on the
results of the Optiography(TM) Scan," explained Dr. Tearney. The
presentation, titled "The Promise and Reality of Raman Spectroscopy for
Atherosclerosis Imaging: Advantages and Limitations," will be held at 1:44
pm, Monday October 13, in room 152A of the Washington Convention Center.
Recent preclinical results with the vPredict(TM) Optical Catheter
System will be available through the duration of TCT 2008 via e-poster
kiosks. The e-poster presentation, "Discrimination Between Cholesterol and
Cholesterol Esters in Coronary Artery Tissue with Raman Spectroscopy," was
authored by Jon Nazemi, MS, and James F. Brennan III, PhD.
About Prescient Medical, Inc.
Prescient Medical, Inc. is a privately held medical device company
dedicated to reducing deaths from heart attacks and cardiovascular disease,
the leading causes of death in much of the world.
Prescient Medical, Inc.
prescientmedical
among the first to hear a report on initial clinical experiences with the
vProtect(TM) Luminal Shield in patients with non-flow-limiting "vulnerable"
plaques. Professor Patrick Serruys, Director of Clinical Research and chief
of interventional cardiology at the Erasmus Medical Center in Rotterdam,
the Netherlands, will present early findings and describe the rationale and
design of the SECRITT I trial, a randomized pilot study of the device in
patients with vulnerable plaque. According to Prof. Serruys, "Vulnerable
plaques can rupture suddenly, and with catastrophic results. If the
vProtect(TM) Luminal Shield can gently stabilize these plaques, as it is
designed to do, it will be a break-through, a paradigm shift in
interventional cardiology." Prof. Serruys's presentation, "Progress with a
Vulnerable Plaque Shield and a 'Secret' Trial," is scheduled for 4:18 pm,
Monday October 13, in room 152A of the Walter E. Washington Convention
Center, Washington DC.
Its unique self-expanding and biocompatible design makes the
vProtect(TM) Luminal Shield a potentially attractive alternative to
traditional stents in established indications. Juan Granada, MD, will
present details on the innovative design of the vProtect(TM) Luminal Shield
and an update on the ongoing first-in-human study of the Shield at 11:52 am
on Monday October 13, in room 145AB of the Washington Convention Center.
Prescient Medical is also spearheading an effort to better identify and
characterize vulnerable plaques, a project that strongly complements the
vProtect(TM) Luminal Shield development program. Guillermo Tearney, MD,
PhD, of the Wellman Center for Photomedicine, Massachusetts General
Hospital, will present new results related to the use of the vPredict(TM)
Optical Catheter System for characterizing vulnerable plaques at TCT 2008.
The vPredict(TM) platform is based on Raman spectroscopy, a highly
sensitive technique that is used in scores of critical non-clinical
applications. "The vPredict(TM) Optical Catheter System can detect the
spectroscopic 'fingerprints' of compounds in the plaque. Our task is to
correlate the spectra we obtain to histology, so that we can classify a
plaque, and ultimately assess its risk of rupture in vivo, based on the
results of the Optiography(TM) Scan," explained Dr. Tearney. The
presentation, titled "The Promise and Reality of Raman Spectroscopy for
Atherosclerosis Imaging: Advantages and Limitations," will be held at 1:44
pm, Monday October 13, in room 152A of the Washington Convention Center.
Recent preclinical results with the vPredict(TM) Optical Catheter
System will be available through the duration of TCT 2008 via e-poster
kiosks. The e-poster presentation, "Discrimination Between Cholesterol and
Cholesterol Esters in Coronary Artery Tissue with Raman Spectroscopy," was
authored by Jon Nazemi, MS, and James F. Brennan III, PhD.
About Prescient Medical, Inc.
Prescient Medical, Inc. is a privately held medical device company
dedicated to reducing deaths from heart attacks and cardiovascular disease,
the leading causes of death in much of the world.
Prescient Medical, Inc.
prescientmedical
суббота, 14 мая 2011 г.
Start Of Prolarix™ Phase 2 Study In Liver Cancer
Protherics PLC ("Protherics" or the "Company"), the international biopharmaceutical company focused on critical care and cancer, announces the initiation of a phase 2a proof-of-concept study of Prolarix™, a targeted prodrug chemotherapy being developed for the treatment of primary liver cancer (hepatocellular carcinoma or "HCC"). This follows promising data from a phase 1 study of Prolarix, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA on 2 June 2008.
HCC is the sixth most common cause of cancer in the world1 and despite the recent approval of sorafenib (Nexavar®, Onyx/Bayer), a new chemotherapy which is being adopted as the standard of care for HCC, life expectancy remains less than 12 months from diagnosis. Moreover, less than 20% of patients survive beyond one year, and less than 5% survive beyond five years.
The phase 2a proof-of-concept study is designed to evaluate tumour response in addition to safety and tolerability of Prolarix in 14 patients with non-resectable HCC who have not been treated with sorafenib. The study has been initiated at a site in Belgium and additional study sites in East Asia have been identified for inclusion in the study. The results of the study are expected in the second half of 2009.
Andrew Heath, Chief Executive of Protherics commented:
"Scientifically acclaimed, Prolarix offers renewed hope for the many patients with primary liver cancer for whom there are very few treatment options. If the results from this study are positive, a licensing partner will be sought for Asia where the incidence of this type of cancer is highest."
1 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002 CA Cancer J Clin. 2005;55;74-108
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading international biopharmaceutical company focused on specialist products for critical care and cancer.
The Company has two critical care products, CroFab™ and DigiFab™, approved for sale in the US. The Company has the opportunity to sell these products in the US from October 2010 together with Voraxaze™, a supportive cancer care product, following anticipated approval in the US in 2010. Protherics is also developing a number of other products in the cancer arena that it can commercialise in-house.
In addition, Protherics has several potential blockbuster products that require development and commercialisation partners. These include CytoFab™ which has been partnered by AstraZeneca in a major licensing deal, and also Angiotensin Therapeutic Vaccine and Digoxin Immune Fabs for which licensing partners will be sought in 2008-2009. These products have the potential to be high value products that can provide additional funding for the Company.
Protherics reported revenues of ??26.1 million for the year ended 31 March 2008 and a strong cash balance of ??37.7 million. With headquarters in London, the Company has approximately 300 employees across its operations in the UK, US and Australia.
About Prolarix™
Prolarix is a targeted chemotherapy being developed for the treatment of primary liver cancer (hepatocellular carcinomas, HCC) and other select tumours. Prolarix is a combination therapy of two low molecular weight compounds, a prodrug* (called tretazicar; previously CB1954) and an enzyme co-substrate* (called caricotamide; previously EP-0152R). The prodrug tretazicar can be activated by an endogenous enzyme called NQO2, to a highly reactive, short-lived cytotoxic agent which causes a high degree of DNA cross-linking. The NQO2 enzyme is latent and therefore inactive in body tissue, but Protherics' scientists have discovered that the enzyme is active in the presence of a co-substrate called caricotamide. The NQO2 enzyme is absent or in low levels in many normal body tissues, including bone marrow, but its activity is increased in certain tumour types (particularly hepatocellular carcinomas). The coadministration of the prodrug tretazicar and the cosubstrate caricotamide is therefore expected to result in the enhanced activation of the prodrug in the target tumour cells, resulting in their death whilst minimising harm to healthy, non-cancerous cells.
Glossary
Prodrug* - A compound that is converted within the body into its active form and that has no therapeutic effects of its own. A prodrug is useful when the active drug may be too toxic to administer systemically, the active drug is absorbed poorly by the digestive tract, or the body breaks down the active drug before it reaches its target.
Co-substrate* - A molecule that interacts with an enzyme and is required for its activity.
Cytotoxic* - A chemical which has a direct toxic effect to cells, causing their death.
Tretazicar* is 5-(aziridin-1-yl)-2,4-dinitrobenzamide (CB1954), an antitumour prodrug
Caricotamide* is 1-carbamoylmethyl-3-carbamoyl-1,4-dihydropyridine (EP-0152R), the most stable of a series of co-substrates for NQO2 discovered by Protherics
Protherics PLC
View drug information on Nexavar.
HCC is the sixth most common cause of cancer in the world1 and despite the recent approval of sorafenib (Nexavar®, Onyx/Bayer), a new chemotherapy which is being adopted as the standard of care for HCC, life expectancy remains less than 12 months from diagnosis. Moreover, less than 20% of patients survive beyond one year, and less than 5% survive beyond five years.
The phase 2a proof-of-concept study is designed to evaluate tumour response in addition to safety and tolerability of Prolarix in 14 patients with non-resectable HCC who have not been treated with sorafenib. The study has been initiated at a site in Belgium and additional study sites in East Asia have been identified for inclusion in the study. The results of the study are expected in the second half of 2009.
Andrew Heath, Chief Executive of Protherics commented:
"Scientifically acclaimed, Prolarix offers renewed hope for the many patients with primary liver cancer for whom there are very few treatment options. If the results from this study are positive, a licensing partner will be sought for Asia where the incidence of this type of cancer is highest."
1 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002 CA Cancer J Clin. 2005;55;74-108
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading international biopharmaceutical company focused on specialist products for critical care and cancer.
The Company has two critical care products, CroFab™ and DigiFab™, approved for sale in the US. The Company has the opportunity to sell these products in the US from October 2010 together with Voraxaze™, a supportive cancer care product, following anticipated approval in the US in 2010. Protherics is also developing a number of other products in the cancer arena that it can commercialise in-house.
In addition, Protherics has several potential blockbuster products that require development and commercialisation partners. These include CytoFab™ which has been partnered by AstraZeneca in a major licensing deal, and also Angiotensin Therapeutic Vaccine and Digoxin Immune Fabs for which licensing partners will be sought in 2008-2009. These products have the potential to be high value products that can provide additional funding for the Company.
Protherics reported revenues of ??26.1 million for the year ended 31 March 2008 and a strong cash balance of ??37.7 million. With headquarters in London, the Company has approximately 300 employees across its operations in the UK, US and Australia.
About Prolarix™
Prolarix is a targeted chemotherapy being developed for the treatment of primary liver cancer (hepatocellular carcinomas, HCC) and other select tumours. Prolarix is a combination therapy of two low molecular weight compounds, a prodrug* (called tretazicar; previously CB1954) and an enzyme co-substrate* (called caricotamide; previously EP-0152R). The prodrug tretazicar can be activated by an endogenous enzyme called NQO2, to a highly reactive, short-lived cytotoxic agent which causes a high degree of DNA cross-linking. The NQO2 enzyme is latent and therefore inactive in body tissue, but Protherics' scientists have discovered that the enzyme is active in the presence of a co-substrate called caricotamide. The NQO2 enzyme is absent or in low levels in many normal body tissues, including bone marrow, but its activity is increased in certain tumour types (particularly hepatocellular carcinomas). The coadministration of the prodrug tretazicar and the cosubstrate caricotamide is therefore expected to result in the enhanced activation of the prodrug in the target tumour cells, resulting in their death whilst minimising harm to healthy, non-cancerous cells.
Glossary
Prodrug* - A compound that is converted within the body into its active form and that has no therapeutic effects of its own. A prodrug is useful when the active drug may be too toxic to administer systemically, the active drug is absorbed poorly by the digestive tract, or the body breaks down the active drug before it reaches its target.
Co-substrate* - A molecule that interacts with an enzyme and is required for its activity.
Cytotoxic* - A chemical which has a direct toxic effect to cells, causing their death.
Tretazicar* is 5-(aziridin-1-yl)-2,4-dinitrobenzamide (CB1954), an antitumour prodrug
Caricotamide* is 1-carbamoylmethyl-3-carbamoyl-1,4-dihydropyridine (EP-0152R), the most stable of a series of co-substrates for NQO2 discovered by Protherics
Protherics PLC
View drug information on Nexavar.
пятница, 13 мая 2011 г.
DelSite Working Toward Solving Delivery Of Influenza Vaccine In Pandemic Situations
Officials of DelSite
Biotechnologies, Inc., a wholly-owned subsidiary of Carrington
Laboratories, Inc. (Nasdaq: CARN), said the company's novel powder-based
vaccine delivery technology may solve most of the key obstacles that delay
influenza pandemic preparedness which were discussed by experts at the
worldwide "Options for the Control of Influenza VI Conference" held in
Toronto, Canada last week.
Long-standing problems associated with the production, storage and
distribution of vaccines to meet the challenges posed by a pandemic
outbreak of an influenza virus, such as the bird flu (H5N1), were
highlighted in a series of presentations at the conference. The Conference
was supported by the U.S. Center for Disease Control (CDC) and the
International Society for Influenza and other Respiratory Virus Diseases
(ISIRV). More than 1,500 influenza experts from around the world attended
the conference, including government policy makers, pharmaceutical
executives, researchers, physicians, epidemiologists and other
professionals focused on the control of influenza.
The following key needs were cited:
1. The ability to have an adequate stockpile of vaccines. Current vaccines
must be refrigerated during storage and distribution. Despite its cost
and inconvenience, cold storage does not significantly extend the short
shelf life of influenza antigens and vaccines. DelSite's GelVac(TM)
powder vaccine system has been shown to stabilize and preserve an
influenza antigen at room temperature for more than two (2) years
without loss of potency.
2. The capability to implement rapid distribution in the event of a full
pandemic. According to one flu expert, if the next influenza pandemic
is equivalent to the flu pandemic that occurred in 1957 (H2N2 virus),
timing of actions by the U.S. government would be critical. In 1957,
under transportation systems available at the time, it took only six
months for the virus to travel from China to the U.S. With today's
faster transportation systems allowing 1.2 million people to enter the
U.S. each day, it is anticipated the virus would spread much faster.
For containment of disease, a massive and expeditious vaccination
program, along with other measures, would have to be initiated as
quickly as possible.
According to the same expert, about 10 million doses per week for 25
weeks would have to be delivered in order to protect the U.S.
population during a full pandemic. Current cold chain distribution
systems may not be able to respond, but a nasal powder vaccine that can
be shipped at room temperature and be self-administered may be a
solution. DelSite's nasal powder technology meets these criteria and
could add additional value by providing immunological protection to
recipients at the site where viruses normally enter the body: the
respiratory tract.
3. An effective adjuvant to make the vaccine more powerful. One proposed
approach was to have the vaccine in one vial and the adjuvant in
another vial, and then combine the vaccine with the adjuvant at the
site of vaccination. It was suggested that this approach would allow
for better stockpiling of the adjuvant, which would have a longer shelf
life than the vaccine antigen. However, this system may double
distribution logistics and therefore may be less feasible.
DelSite has data indicating that the GelVac(TM) powder formulation
could be shipped as a powder and reconstituted with sterile water just
prior to injection. GelVac(TM) powder formulation also has a strong
immuno-enhancing or adjuvant-like effect when it is injected after
reconstitution through sustained release of the injected antigen. This
effect could provide protection for more people at lower doses without
the need for a separate adjuvant.
4. A way to reduce the number of months required to produce necessary
antigen, if different from stockpile. Currently, chicken eggs are used
in the U.S. for production of vaccine antigens. This egg-based
manufacturing process requires a minimum of six months. The newest
technology available uses a mammalian cell line to produce antigens.
This cell-based technology is more efficient, faster, and eliminates
allergic problems caused by egg proteins. DelSite's GelVac(TM) powder
vaccine technology works with egg- or cell-based antigen. In addition,
the use of a whole virus (whole virion) provides more potent vaccines
than vaccines produced using split or partial parts of the virus; the
GelVac(TM) technology may be used to deliver vaccines made from any of
these methods.
DelSite's GelVac(TM) platform is based on the GelSite(R) polymer, a
negatively-charged linear polymer with a molecular weight greater than
450,000 which is derived from a natural source and is classified as a GRAS
(generally regarded as safe) by the FDA. GelSite(R) is produced in kilogram
quantities under FDA good manufacturing practices for human drugs (cGMP) in
an ISO-certified facility. Each kilogram of the GelSite(R) polymer can be
used to manufacture approximately 5 to 8 million vaccine doses. Plant
material used in the production of GelSite(R) polymer is recognized as
certified organic by the U.S. Department of Agriculture, European Union and
government of Costa Rica.
After the Influenza Conference concluded, Dr. Yawei Ni, chief
scientific officer of DelSite, stated, "Our GelVac(TM) powder vaccine
delivery platform was the only powder system at the conference, and I
believe it can be used to solve or alleviate basic technology problems that
would be created by a worldwide pandemic. We have completed the Phase I
safety study for the powder system and will file an IND with the FDA for a
Phase I clinical study using a H5N1 antigen later this year."
About DelSite
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., is
developing its proprietary GelSite(R) technology designed to provide
controlled release of peptide and protein-based drugs and vaccines. DelSite
is currently developing a nasal powder vaccine using its GelVac(TM) formula
with the H5N1 avian flu antigen. This work is partially funded by two
grants from NIAID (National Institute of Allergy and Infectious Diseases)
of NIH (National Institute of Health) under the Department of Health and
Human Services.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based,
biopharmaceutical and consumer products company currently utilizing
naturally-occurring complex carbohydrates to manufacture and market
products for mucositis, radiation dermatitis, wound and oral care, as well
as to manufacture and market the nutraceutical raw material Manapol(R) and
cosmetic raw material Hydrapol(TM). Carrington also manufactures and
markets consumer products and manufactures quality products for other
companies. Manufacturing operations comply with cGMP standards.
Carrington's DelSite Biotechnologies subsidiary is developing its
proprietary GelSite(R) technology designed to provide controlled release of
peptide and protein-based drugs. Carrington's technology is protected by
more than 130 patents in 26 countries. Select products carry the CE mark,
recognized by more than 20 countries around the world. For more
information, visit carringtonlabs.
Certain statements in this release concerning Carrington may be
forward-looking. Actual events will be dependent upon a number of factors
and risks including, but not limited to: subsequent changes in plans by the
Company's management; delays or problems in formulation, manufacturing,
distribution, production and/or launch of new finished products; changes in
the regulatory process; changes in market trends; and a number of other
factors and risks described from time to time in the Company's filings with
the Securities & Exchange Commission, including the Form 10-Q, filed May
15, 2007.
Carrington Laboratories, Inc.
carringtonlabs
View drug information on Carrington patch.
Biotechnologies, Inc., a wholly-owned subsidiary of Carrington
Laboratories, Inc. (Nasdaq: CARN), said the company's novel powder-based
vaccine delivery technology may solve most of the key obstacles that delay
influenza pandemic preparedness which were discussed by experts at the
worldwide "Options for the Control of Influenza VI Conference" held in
Toronto, Canada last week.
Long-standing problems associated with the production, storage and
distribution of vaccines to meet the challenges posed by a pandemic
outbreak of an influenza virus, such as the bird flu (H5N1), were
highlighted in a series of presentations at the conference. The Conference
was supported by the U.S. Center for Disease Control (CDC) and the
International Society for Influenza and other Respiratory Virus Diseases
(ISIRV). More than 1,500 influenza experts from around the world attended
the conference, including government policy makers, pharmaceutical
executives, researchers, physicians, epidemiologists and other
professionals focused on the control of influenza.
The following key needs were cited:
1. The ability to have an adequate stockpile of vaccines. Current vaccines
must be refrigerated during storage and distribution. Despite its cost
and inconvenience, cold storage does not significantly extend the short
shelf life of influenza antigens and vaccines. DelSite's GelVac(TM)
powder vaccine system has been shown to stabilize and preserve an
influenza antigen at room temperature for more than two (2) years
without loss of potency.
2. The capability to implement rapid distribution in the event of a full
pandemic. According to one flu expert, if the next influenza pandemic
is equivalent to the flu pandemic that occurred in 1957 (H2N2 virus),
timing of actions by the U.S. government would be critical. In 1957,
under transportation systems available at the time, it took only six
months for the virus to travel from China to the U.S. With today's
faster transportation systems allowing 1.2 million people to enter the
U.S. each day, it is anticipated the virus would spread much faster.
For containment of disease, a massive and expeditious vaccination
program, along with other measures, would have to be initiated as
quickly as possible.
According to the same expert, about 10 million doses per week for 25
weeks would have to be delivered in order to protect the U.S.
population during a full pandemic. Current cold chain distribution
systems may not be able to respond, but a nasal powder vaccine that can
be shipped at room temperature and be self-administered may be a
solution. DelSite's nasal powder technology meets these criteria and
could add additional value by providing immunological protection to
recipients at the site where viruses normally enter the body: the
respiratory tract.
3. An effective adjuvant to make the vaccine more powerful. One proposed
approach was to have the vaccine in one vial and the adjuvant in
another vial, and then combine the vaccine with the adjuvant at the
site of vaccination. It was suggested that this approach would allow
for better stockpiling of the adjuvant, which would have a longer shelf
life than the vaccine antigen. However, this system may double
distribution logistics and therefore may be less feasible.
DelSite has data indicating that the GelVac(TM) powder formulation
could be shipped as a powder and reconstituted with sterile water just
prior to injection. GelVac(TM) powder formulation also has a strong
immuno-enhancing or adjuvant-like effect when it is injected after
reconstitution through sustained release of the injected antigen. This
effect could provide protection for more people at lower doses without
the need for a separate adjuvant.
4. A way to reduce the number of months required to produce necessary
antigen, if different from stockpile. Currently, chicken eggs are used
in the U.S. for production of vaccine antigens. This egg-based
manufacturing process requires a minimum of six months. The newest
technology available uses a mammalian cell line to produce antigens.
This cell-based technology is more efficient, faster, and eliminates
allergic problems caused by egg proteins. DelSite's GelVac(TM) powder
vaccine technology works with egg- or cell-based antigen. In addition,
the use of a whole virus (whole virion) provides more potent vaccines
than vaccines produced using split or partial parts of the virus; the
GelVac(TM) technology may be used to deliver vaccines made from any of
these methods.
DelSite's GelVac(TM) platform is based on the GelSite(R) polymer, a
negatively-charged linear polymer with a molecular weight greater than
450,000 which is derived from a natural source and is classified as a GRAS
(generally regarded as safe) by the FDA. GelSite(R) is produced in kilogram
quantities under FDA good manufacturing practices for human drugs (cGMP) in
an ISO-certified facility. Each kilogram of the GelSite(R) polymer can be
used to manufacture approximately 5 to 8 million vaccine doses. Plant
material used in the production of GelSite(R) polymer is recognized as
certified organic by the U.S. Department of Agriculture, European Union and
government of Costa Rica.
After the Influenza Conference concluded, Dr. Yawei Ni, chief
scientific officer of DelSite, stated, "Our GelVac(TM) powder vaccine
delivery platform was the only powder system at the conference, and I
believe it can be used to solve or alleviate basic technology problems that
would be created by a worldwide pandemic. We have completed the Phase I
safety study for the powder system and will file an IND with the FDA for a
Phase I clinical study using a H5N1 antigen later this year."
About DelSite
Carrington's wholly-owned subsidiary DelSite Biotechnologies, Inc., is
developing its proprietary GelSite(R) technology designed to provide
controlled release of peptide and protein-based drugs and vaccines. DelSite
is currently developing a nasal powder vaccine using its GelVac(TM) formula
with the H5N1 avian flu antigen. This work is partially funded by two
grants from NIAID (National Institute of Allergy and Infectious Diseases)
of NIH (National Institute of Health) under the Department of Health and
Human Services.
About Carrington
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based,
biopharmaceutical and consumer products company currently utilizing
naturally-occurring complex carbohydrates to manufacture and market
products for mucositis, radiation dermatitis, wound and oral care, as well
as to manufacture and market the nutraceutical raw material Manapol(R) and
cosmetic raw material Hydrapol(TM). Carrington also manufactures and
markets consumer products and manufactures quality products for other
companies. Manufacturing operations comply with cGMP standards.
Carrington's DelSite Biotechnologies subsidiary is developing its
proprietary GelSite(R) technology designed to provide controlled release of
peptide and protein-based drugs. Carrington's technology is protected by
more than 130 patents in 26 countries. Select products carry the CE mark,
recognized by more than 20 countries around the world. For more
information, visit carringtonlabs.
Certain statements in this release concerning Carrington may be
forward-looking. Actual events will be dependent upon a number of factors
and risks including, but not limited to: subsequent changes in plans by the
Company's management; delays or problems in formulation, manufacturing,
distribution, production and/or launch of new finished products; changes in
the regulatory process; changes in market trends; and a number of other
factors and risks described from time to time in the Company's filings with
the Securities & Exchange Commission, including the Form 10-Q, filed May
15, 2007.
Carrington Laboratories, Inc.
carringtonlabs
View drug information on Carrington patch.
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