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
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