ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that a Phase III study of ERBITUX(R) (Cetuximab) in
combination with platinum-based chemotherapy (vinorelbine plus cisplatin)
met its primary endpoint of increasing overall survival compared with
chemotherapy alone in patients with advanced non-small cell lung cancer
(NSCLC). This large, randomized multi-national study, known as FLEX
(First-Line Treatment for Patients with Epidermal growth factor inhibitor
(EGFR)-EXpressing Advanced NSCLC) was conducted by Merck KGaA, Darmstadt,
Germany and enrolled patients with Stage IIIB or Stage IV NSCLC who had not
previously received chemotherapy.
"Based on the FLEX results, ERBITUX is the only member of the class of
epidermal growth factor inhibitors to demonstrate survival in the
first-line treatment of patients with advanced non-small cell lung cancer.
Previous pivotal trials involving other agents targeting EGFR have failed
to demonstrate a survival advantage for these patients," stated Eric K.
Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone
Systems. "These are important results for lung cancer patients and health
care professionals treating this devastating disease, since there have been
very few treatment advances for lung cancer in recent years."
"Studies have shown that ERBITUX improves overall survival for patients
with certain head and neck cancers, and now, with the FLEX data, for
patients with advanced non-small cell lung cancer," said Martin Birkhofer,
M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers
Squibb. "We look forward to sharing these data with the medical community."
Results from this study will be submitted for presentation at an
upcoming medical conference.
Merck KGaA, Darmstadt, Germany, is ImClone Systems' ERBITUX partner
outside of North America.
About Lung Cancer
The American Cancer Society estimates that in the U.S., more than
213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is
the leading cause of cancer-related death in men and women in the U.S.,
with 160,000 deaths estimated in 2007. Approximately 80 to 85% of these
patients will be diagnosed with non-small cell lung cancer, with the
majority being diagnosed with locally advanced or metastatic disease.
About ERBITUX(R) (Cetuximab)
ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the
function of a molecular structure expressed on the surface of normal and
tumor cells called the epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1). In vitro assays and in vivo animal studies have shown that
binding of ERBITUX to the EGFR blocks phosphorylation and activation of
receptor-associated kinases, resulting in inhibition of cell growth,
induction of apoptosis, and decreased matrix metalloproteinase and vascular
endothelial growth factor production. In vitro, ERBITUX can mediate
antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor
types. While the mechanism of ERBITUX's anti-tumor effect(s) in vivo is
unknown, all of these processes may contribute to the overall therapeutic
effect of ERBITUX. EGFR is part of a signaling pathway that is linked to
the growth and development of many human cancers, including those of the
head and neck, colon and rectum.
ERBITUX (Cetuximab), in combination with radiation therapy, is
indicated for the treatment of locally or regionally advanced squamous cell
carcinoma of the head and neck. ERBITUX as a single agent is indicated for
the treatment of patients with recurrent or metastatic squamous cell
carcinoma of the head and neck for whom prior platinum-based therapy has
failed.
ERBITUX is indicated for the treatment of EGFR-expressing, metastatic
colorectal carcinoma (mCRC) in combination with irinotecan for patients who
are refractory to irinotecan-based chemotherapy, and as a single agent for
patients who are intolerant to irinotecan-based therapy. The effectiveness
of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on
objective response rates. Currently, no data are available that demonstrate
an improvement in disease-related symptoms or increased survival with
ERBITUX for the treatment of EGFR-expressing mCRC.
For full prescribing information, including boxed WARNINGS regarding
infusion reactions and cardiopulmonary arrest, visit
ERBITUX.
Important Safety Information
Grade 3/4 infusion reactions, rarely with fatal outcome (
четверг, 16 июня 2011 г.
среда, 15 июня 2011 г.
TargeGen Announces Initiation Of Clinical Trial Of JAK2 Inhibitor TG101348 In Myeloproliferative Disease Patients
TargeGen, Inc. announced that
the Company has started a multi-center Phase I/II clinical trial of
TG101348, an oral, potent, and highly selective inhibitor of JAK2 in
patients with myeloproliferative diseases.
The V617F mutation of JAK2 is implicated in the pathogenesis of certain
myeloproliferative diseases, including polycythemia vera (PV), essential
thrombocytopenia (ET) and primary myelofibrosis (PMF). In preclinical
models of myeloproliferative diseases, TG101348, administered orally, was
shown to reduce V617F-expressing cell populations in a dose-dependant
manner without adversely impacting normal hematopoeisis. The reduction of
V617F-expressing cell populations correlated with improved survival and
reduced morbidity. There are no currently approved specific therapies for
PV, ET and PMF. These disorders are estimated to affect approximately
200,000 patients in the United States and more than twice that total
worldwide.
The current clinical trial is being conducted at multiple centers in
the USA. The trial is expected to enroll between 40-80 patients. Primary
goals of this open label dose escalating protocol include identification of
a maximum tolerated dose (MTD), accumulation of safety data, measurement of
drug effect on surrogate markers, biomarkers, and presumptive clinical
endpoints.
About TargeGen, Inc.
TargeGen, Inc. is a privately held vascular biology-focused
biopharmaceutical company based in San Diego, CA. TargeGen primarily
develops small molecule kinase inhibitors that target vascular leakage
(edema), vascular proliferation (angiogenesis) and inflammation. Edema,
angiogenesis and inflammation are involved in the pathology of many major
human diseases.
TargeGen initiated operations in 2002 and has raised capital from top
tier venture capital sources. Current investors include VantagePoint
Venture Partners, Forward Ventures, Enterprise Partners, Chicago Growth
Partners, BB BIOTECH VENTURES, Innovis Investments, H&Q Capital Management,
Pappas Ventures, CTI Life Sciences and other investors.
TargeGen, Inc.
targegen
the Company has started a multi-center Phase I/II clinical trial of
TG101348, an oral, potent, and highly selective inhibitor of JAK2 in
patients with myeloproliferative diseases.
The V617F mutation of JAK2 is implicated in the pathogenesis of certain
myeloproliferative diseases, including polycythemia vera (PV), essential
thrombocytopenia (ET) and primary myelofibrosis (PMF). In preclinical
models of myeloproliferative diseases, TG101348, administered orally, was
shown to reduce V617F-expressing cell populations in a dose-dependant
manner without adversely impacting normal hematopoeisis. The reduction of
V617F-expressing cell populations correlated with improved survival and
reduced morbidity. There are no currently approved specific therapies for
PV, ET and PMF. These disorders are estimated to affect approximately
200,000 patients in the United States and more than twice that total
worldwide.
The current clinical trial is being conducted at multiple centers in
the USA. The trial is expected to enroll between 40-80 patients. Primary
goals of this open label dose escalating protocol include identification of
a maximum tolerated dose (MTD), accumulation of safety data, measurement of
drug effect on surrogate markers, biomarkers, and presumptive clinical
endpoints.
About TargeGen, Inc.
TargeGen, Inc. is a privately held vascular biology-focused
biopharmaceutical company based in San Diego, CA. TargeGen primarily
develops small molecule kinase inhibitors that target vascular leakage
(edema), vascular proliferation (angiogenesis) and inflammation. Edema,
angiogenesis and inflammation are involved in the pathology of many major
human diseases.
TargeGen initiated operations in 2002 and has raised capital from top
tier venture capital sources. Current investors include VantagePoint
Venture Partners, Forward Ventures, Enterprise Partners, Chicago Growth
Partners, BB BIOTECH VENTURES, Innovis Investments, H&Q Capital Management,
Pappas Ventures, CTI Life Sciences and other investors.
TargeGen, Inc.
targegen
вторник, 14 июня 2011 г.
Cordis Corporation Starts Pivotal Trial For ExoSeal(TM) Vascular Closure Device
Cordis Corporation, a
worldwide leader in developing and manufacturing interventional vascular
technology, announced today the start of the pivotal trial for the
ExoSeal(TM) Vascular Closure Device. The ECLIPSE Trial is a multicenter,
non-blinded, randomized study designed to measure the safety and efficacy
of the ExoSeal(TM) Vascular Closure Device versus manual compression to
close vascular access sites in patients having undergone diagnostic or
interventional procedures. The trial will encompass 400 patients from 18
medical centers across the United States.
On February 13, Principal Investigator Chiu Wong, M.D., Associate
Professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center and a Cordis Corporation Consultant, treated the first patient in
the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal(TM)
Vascular Closure Device had been used in 150 patients participating in a
first-in-human study for the device.
"The results from the first-in-man study were very encouraging, and
this trial will help us determine whether those results can be maintained
in a larger number of patients," said Dr. Wong. "As an interventional
cardiologist, I welcome the opportunity to investigate a device that could
help patients recover faster from a catheterization procedure."
The ExoSeal(TM) Vascular Closure Device features a synthetic
bioabsorbable polymer and is being studied to determine whether it can
enable expedited hemostasis (the cessation of bleeding), faster patient
ambulation (ability to walk) and reduced bed-stay after a catheterization
procedure. It also represents Cordis' entry into the vascular closure
device market. Nearly eight million patients undergo cardiac
catheterization procedures annually.
"The swift progress of the ExoSeal(TM) Vascular Closure Device from the
proof-of-concept stage to a pivotal trial in only seven months marks a
major milestone in Cordis' efforts to accelerate the development of new
devices to improve the treatment of vascular diseases," said Campbell
Rogers, M.D., Chief Technology Officer, Cordis Corporation. "The ECLIPSE
Trial will help us evaluate whether the ExoSeal(TM) Vascular Closure Device
could make a significant and positive difference in patients' comfort as
well as recovery time following a catheterization procedure."
Catheterization procedures involve the temporary insertion of a
catheter into an artery, usually the femoral artery, through a vascular
puncture. While a variety of methods, such as manual compression, sandbags
and mechanical clamps have been used to close the puncture site and stop
the bleeding after the catheter is removed, many of these methods cause
significant discomfort and require several hours of bed-rest.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in developing and manufacturing interventional vascular technology. Through
the company's innovation, research and development, physicians worldwide
are better able to treat the millions of patients who suffer from vascular
disease. For more information, visit cordis.
Cordis Corporation
cordis
worldwide leader in developing and manufacturing interventional vascular
technology, announced today the start of the pivotal trial for the
ExoSeal(TM) Vascular Closure Device. The ECLIPSE Trial is a multicenter,
non-blinded, randomized study designed to measure the safety and efficacy
of the ExoSeal(TM) Vascular Closure Device versus manual compression to
close vascular access sites in patients having undergone diagnostic or
interventional procedures. The trial will encompass 400 patients from 18
medical centers across the United States.
On February 13, Principal Investigator Chiu Wong, M.D., Associate
Professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center and a Cordis Corporation Consultant, treated the first patient in
the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal(TM)
Vascular Closure Device had been used in 150 patients participating in a
first-in-human study for the device.
"The results from the first-in-man study were very encouraging, and
this trial will help us determine whether those results can be maintained
in a larger number of patients," said Dr. Wong. "As an interventional
cardiologist, I welcome the opportunity to investigate a device that could
help patients recover faster from a catheterization procedure."
The ExoSeal(TM) Vascular Closure Device features a synthetic
bioabsorbable polymer and is being studied to determine whether it can
enable expedited hemostasis (the cessation of bleeding), faster patient
ambulation (ability to walk) and reduced bed-stay after a catheterization
procedure. It also represents Cordis' entry into the vascular closure
device market. Nearly eight million patients undergo cardiac
catheterization procedures annually.
"The swift progress of the ExoSeal(TM) Vascular Closure Device from the
proof-of-concept stage to a pivotal trial in only seven months marks a
major milestone in Cordis' efforts to accelerate the development of new
devices to improve the treatment of vascular diseases," said Campbell
Rogers, M.D., Chief Technology Officer, Cordis Corporation. "The ECLIPSE
Trial will help us evaluate whether the ExoSeal(TM) Vascular Closure Device
could make a significant and positive difference in patients' comfort as
well as recovery time following a catheterization procedure."
Catheterization procedures involve the temporary insertion of a
catheter into an artery, usually the femoral artery, through a vascular
puncture. While a variety of methods, such as manual compression, sandbags
and mechanical clamps have been used to close the puncture site and stop
the bleeding after the catheter is removed, many of these methods cause
significant discomfort and require several hours of bed-rest.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in developing and manufacturing interventional vascular technology. Through
the company's innovation, research and development, physicians worldwide
are better able to treat the millions of patients who suffer from vascular
disease. For more information, visit cordis.
Cordis Corporation
cordis
понедельник, 13 июня 2011 г.
Promising Results From 2 Trials Highlighting Pomalidomide Presented At ASH
Celgene International Sarl (Nasdaq: CELG) has announced that its next IMiDs compound, pomalidomide, has shown promising activity with manageable safety and tolerability for the treatment of relapsed/refractory multiple myeloma (MM) and myelofibrosis. The data were presented at the 50th Annual American Society of Hematology meeting in San Francisco, CA.
Early analysis of the Phase II MM study, in which half of the 60 patients with relapsed MM received combined low-dose dexamethasone with pomalidomide, showed that 76 percent of the patients experienced disease improvement or stabilization. Another key finding showed a 29 percent response rate among patients who previously did not respond to REVLIMID® therapy. Objective response was achieved by 58 percent of patients. Eight of the 60 patients had dose reductions. The most commonly occurring major adverse events were neutropenia (32%), thrombocytopenia (3%) and anemia (3%). Investigators concluded that for most patients, pomalidomide plus low-dose dexamethasone was generally well tolerated with manageable adverse events. However, there was one patient death due to pneumonia while neutropenic in this refractory, pre-treated population.
The study's conclusion was that pomalidomide was highly active in this segment of multiple myeloma patients.
The second Phase II trial, evaluating 84 patients with advanced myelofibrosis with myeloid metaplasia, was a four-arm blinded adaptive design trial. The study evaluated two different doses of pomalidomide with or without prednisone, with a prednisone-only arm as a control. All but one patient had failed prior therapies. The Grade 2 or greater side effects were infrequent and comparable to the prednisone control except for thrombocytopenia that was experienced in one of 22 patients and one of 19 patients treated with 2 mg of pomalidomide with or without prednisone. Thirty-five percent of the treated pomalidomide patients experienced blood cell transfusion independence. At the time of this presentation, 15 of the 16 responders remain in remission. Granulocytopenia and normal spleen size correlated with response, but the percent of abnormal cytogenetics and the presence of a JAK2 mutation did not.
"The interest in our next IMiDs compound, pomalidomide, by the hematological community was demonstrated by both clinical abstracts being selected for oral presentations at the annual meeting of the American Society of Hematology," stated Jerome B. Zeldis, Chief Medical Officer, Celgene Corporation. "Based on these findings and others, Celgene will be developing pomalidomide for relapsed multiple myeloma and other hematological conditions."
About Pomalidomide
Pomalidomide is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. These immunomodulatory agents, taken orally, have unique multiple mechanisms of action that involve the microenvironment of the cancer cell, not just the malignant cell itself. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
About Multiple Myeloma
Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. Most patients with multiple myeloma, however, have cells that produce a form of immunoglobulin called paraprotein (or M protein), which does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
About Myelofibrosis
Myelofibrosis with myeloid dysplasia is often referred to as a chronic form of leukemia. It is a serious bone marrow disorder that begins in stem cells that form blood cells. Too few red cells are produced with an overproduction of white cells and platelets. That in turn results in a buildup of collagen in the bone marrow cavity, causing extensive scarring. The results are anemia, fatigue and susceptibility to infection.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at celgene.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.
Early analysis of the Phase II MM study, in which half of the 60 patients with relapsed MM received combined low-dose dexamethasone with pomalidomide, showed that 76 percent of the patients experienced disease improvement or stabilization. Another key finding showed a 29 percent response rate among patients who previously did not respond to REVLIMID® therapy. Objective response was achieved by 58 percent of patients. Eight of the 60 patients had dose reductions. The most commonly occurring major adverse events were neutropenia (32%), thrombocytopenia (3%) and anemia (3%). Investigators concluded that for most patients, pomalidomide plus low-dose dexamethasone was generally well tolerated with manageable adverse events. However, there was one patient death due to pneumonia while neutropenic in this refractory, pre-treated population.
The study's conclusion was that pomalidomide was highly active in this segment of multiple myeloma patients.
The second Phase II trial, evaluating 84 patients with advanced myelofibrosis with myeloid metaplasia, was a four-arm blinded adaptive design trial. The study evaluated two different doses of pomalidomide with or without prednisone, with a prednisone-only arm as a control. All but one patient had failed prior therapies. The Grade 2 or greater side effects were infrequent and comparable to the prednisone control except for thrombocytopenia that was experienced in one of 22 patients and one of 19 patients treated with 2 mg of pomalidomide with or without prednisone. Thirty-five percent of the treated pomalidomide patients experienced blood cell transfusion independence. At the time of this presentation, 15 of the 16 responders remain in remission. Granulocytopenia and normal spleen size correlated with response, but the percent of abnormal cytogenetics and the presence of a JAK2 mutation did not.
"The interest in our next IMiDs compound, pomalidomide, by the hematological community was demonstrated by both clinical abstracts being selected for oral presentations at the annual meeting of the American Society of Hematology," stated Jerome B. Zeldis, Chief Medical Officer, Celgene Corporation. "Based on these findings and others, Celgene will be developing pomalidomide for relapsed multiple myeloma and other hematological conditions."
About Pomalidomide
Pomalidomide is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. These immunomodulatory agents, taken orally, have unique multiple mechanisms of action that involve the microenvironment of the cancer cell, not just the malignant cell itself. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
About Multiple Myeloma
Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. Most patients with multiple myeloma, however, have cells that produce a form of immunoglobulin called paraprotein (or M protein), which does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
About Myelofibrosis
Myelofibrosis with myeloid dysplasia is often referred to as a chronic form of leukemia. It is a serious bone marrow disorder that begins in stem cells that form blood cells. Too few red cells are produced with an overproduction of white cells and platelets. That in turn results in a buildup of collagen in the bone marrow cavity, causing extensive scarring. The results are anemia, fatigue and susceptibility to infection.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at celgene.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.
воскресенье, 12 июня 2011 г.
Acambis Is First Company To Test A West Nile Virus Vaccine In Older Adults
Acambis plc (Acambis) (LSE: ACM) announces that
clinical testing of its investigational West Nile virus vaccine,
ChimeriVax(TM)-West Nile, is underway in older adults, those most in need
of protection against West Nile virus infection. Acambis' ChimeriVax-West
Nile is the most advanced West Nile virus vaccine in development and the
first to be tested in older adults.
According to the Centers for Disease Control and Prevention, people
over the age of 50 are more likely to develop serious symptoms from West
Nile virus infection; however, individuals of all ages living in areas
where West Nile virus has been identified are at risk. West Nile virus
continues to be a high-profile problem in the US, causing 4,256 cases and
165 deaths in 2006. This is a more than 41% increase in the number of cases
and 38% increase in deaths compared with 2005.
Acambis' Chief Executive Officer Gordon Cameron commented: "The
significant increase in the number of cases and deaths from West Nile virus
last year reinforces the need for a protective human vaccine. Acambis is
the leader in developing a West Nile virus vaccine and we've taken another
important step by testing ChimerVax-West Nile in older adults, the group
most at risk of severe disease from West Nile virus infection."
The trial is designed to evaluate the safety, tolerability and
immunogenicity of ChimeriVax-West Nile in older adults and is being
conducted in the US. The randomised, double-blind, placebo-controlled study
is the second part of a Phase 2 trial evaluating the vaccine.
Previously, Acambis announced encouraging results from the first part
of the Phase 2 trial, which involved younger adults aged 18-40 years. Over
97% of subjects who received a single dose of ChimeriVax-West Nile
developed neutralising antibodies above the predefined cut-off level 28
days after vaccination. The majority of adverse events were mild in nature.
ChimeriVax-West Nile is being developed to provide a safe, single-dose
West Nile virus vaccine for at-risk individuals. There is currently no
human vaccine against this disease so efforts to reduce the incidence of
infection revolve around preventive measures to protect against mosquito
bites, the cause of nearly all human infections of the virus.
While the majority of West Nile infections are mild and asymptomatic,
approximately 20% of those infected will develop symptoms such as fever,
headache, body aches and swollen glands. The more severe West Nile
encephalitis is estimated to occur in one out of every 150 infections.
Symptoms include high fever, neck stiffness, stupor, convulsions, coma and
sometimes paralysis. Death can occur in the most severe cases when the
virus crosses the blood-brain barrier, leading to encephalitis or
inflammation of the brain.
Since the West Nile virus emerged in the US in 1999, there have been
almost 24,000 cases and 946 deaths.
About ChimeriVax-West Nile
- ChimeriVax-West Nile is being developed to provide a safe,
single-dose West Nile virus vaccine for those at risk from the virus.
- Development of Acambis' investigational vaccine, ChimeriVax-West
Nile, was supported by a $3m grant from the US National Institutes of
Health.
- It is a live, attenuated, injectable vaccine and was developed using
Acambis' proprietary ChimeriVax(TM) technology, which was developed in
association with St Louis University.
- The level of immune response required for protection against West
Nile virus is yet to be determined.
About Acambis
Acambis is a leading biotechnology company targeting infectious
diseases with novel vaccines. Acambis' development-stage pipeline includes
vaccines that could either offer improvements over existing products or
target unmet medical needs. As well as ChimeriVax-JE, Acambis' proprietary
ChimeriVax technology has also been used to develop ChimeriVax-West Nile,
which is undergoing Phase 2 clinical testing, making it the most advanced
investigational vaccine against the West Nile virus. Acambis also has the
only vaccine in development against Clostridium difficile bacteria, a
leading cause of hospital-acquired infections. Recognised internationally
as the leading producer of smallpox vaccines, Acambis is developing an
investigational smallpox vaccine, ACAM2000, and is manufacturing
emergency-use stockpiles of this investigational vaccine for the US
Government and other governments around the world.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and
is listed on the London Stock Exchange (ACM). More information is available
at acambis/.
"Safe Harbor" statement under the Private Securities Litigation Reform
Act of 1995:
The statements in this news release that are not historical facts are
forward-looking statements that involve risks and uncertainties, including
the timing and results of clinical trials, product development,
manufacturing and commercialisation risks, the risks of satisfying the
regulatory approval process in a timely manner, the need for and the
availability of additional capital. For a discussion of these and other
risks and uncertainties see "Risk management' in the Company's 2005 Annual
Report and "Risk factors' in its Form 20-F, in addition to those detailed
on the Company's website and in the Company's filings made with the
Securities and Exchange Commission from time to time. These forward-looking
statements are based on estimates and assumptions made by the management of
Acambis and are believed to be reasonable, though are inherently uncertain
and difficult to predict. Actual results or experience could differ
materially from the forward-looking statements.
Acambis plc
acambis/
clinical testing of its investigational West Nile virus vaccine,
ChimeriVax(TM)-West Nile, is underway in older adults, those most in need
of protection against West Nile virus infection. Acambis' ChimeriVax-West
Nile is the most advanced West Nile virus vaccine in development and the
first to be tested in older adults.
According to the Centers for Disease Control and Prevention, people
over the age of 50 are more likely to develop serious symptoms from West
Nile virus infection; however, individuals of all ages living in areas
where West Nile virus has been identified are at risk. West Nile virus
continues to be a high-profile problem in the US, causing 4,256 cases and
165 deaths in 2006. This is a more than 41% increase in the number of cases
and 38% increase in deaths compared with 2005.
Acambis' Chief Executive Officer Gordon Cameron commented: "The
significant increase in the number of cases and deaths from West Nile virus
last year reinforces the need for a protective human vaccine. Acambis is
the leader in developing a West Nile virus vaccine and we've taken another
important step by testing ChimerVax-West Nile in older adults, the group
most at risk of severe disease from West Nile virus infection."
The trial is designed to evaluate the safety, tolerability and
immunogenicity of ChimeriVax-West Nile in older adults and is being
conducted in the US. The randomised, double-blind, placebo-controlled study
is the second part of a Phase 2 trial evaluating the vaccine.
Previously, Acambis announced encouraging results from the first part
of the Phase 2 trial, which involved younger adults aged 18-40 years. Over
97% of subjects who received a single dose of ChimeriVax-West Nile
developed neutralising antibodies above the predefined cut-off level 28
days after vaccination. The majority of adverse events were mild in nature.
ChimeriVax-West Nile is being developed to provide a safe, single-dose
West Nile virus vaccine for at-risk individuals. There is currently no
human vaccine against this disease so efforts to reduce the incidence of
infection revolve around preventive measures to protect against mosquito
bites, the cause of nearly all human infections of the virus.
While the majority of West Nile infections are mild and asymptomatic,
approximately 20% of those infected will develop symptoms such as fever,
headache, body aches and swollen glands. The more severe West Nile
encephalitis is estimated to occur in one out of every 150 infections.
Symptoms include high fever, neck stiffness, stupor, convulsions, coma and
sometimes paralysis. Death can occur in the most severe cases when the
virus crosses the blood-brain barrier, leading to encephalitis or
inflammation of the brain.
Since the West Nile virus emerged in the US in 1999, there have been
almost 24,000 cases and 946 deaths.
About ChimeriVax-West Nile
- ChimeriVax-West Nile is being developed to provide a safe,
single-dose West Nile virus vaccine for those at risk from the virus.
- Development of Acambis' investigational vaccine, ChimeriVax-West
Nile, was supported by a $3m grant from the US National Institutes of
Health.
- It is a live, attenuated, injectable vaccine and was developed using
Acambis' proprietary ChimeriVax(TM) technology, which was developed in
association with St Louis University.
- The level of immune response required for protection against West
Nile virus is yet to be determined.
About Acambis
Acambis is a leading biotechnology company targeting infectious
diseases with novel vaccines. Acambis' development-stage pipeline includes
vaccines that could either offer improvements over existing products or
target unmet medical needs. As well as ChimeriVax-JE, Acambis' proprietary
ChimeriVax technology has also been used to develop ChimeriVax-West Nile,
which is undergoing Phase 2 clinical testing, making it the most advanced
investigational vaccine against the West Nile virus. Acambis also has the
only vaccine in development against Clostridium difficile bacteria, a
leading cause of hospital-acquired infections. Recognised internationally
as the leading producer of smallpox vaccines, Acambis is developing an
investigational smallpox vaccine, ACAM2000, and is manufacturing
emergency-use stockpiles of this investigational vaccine for the US
Government and other governments around the world.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and
is listed on the London Stock Exchange (ACM). More information is available
at acambis/.
"Safe Harbor" statement under the Private Securities Litigation Reform
Act of 1995:
The statements in this news release that are not historical facts are
forward-looking statements that involve risks and uncertainties, including
the timing and results of clinical trials, product development,
manufacturing and commercialisation risks, the risks of satisfying the
regulatory approval process in a timely manner, the need for and the
availability of additional capital. For a discussion of these and other
risks and uncertainties see "Risk management' in the Company's 2005 Annual
Report and "Risk factors' in its Form 20-F, in addition to those detailed
on the Company's website and in the Company's filings made with the
Securities and Exchange Commission from time to time. These forward-looking
statements are based on estimates and assumptions made by the management of
Acambis and are believed to be reasonable, though are inherently uncertain
and difficult to predict. Actual results or experience could differ
materially from the forward-looking statements.
Acambis plc
acambis/
суббота, 11 июня 2011 г.
From Fruit Fly Wings To Heart Failure. Why Not(ch)?
Almost a century after it was discovered in fruit flies with notches in their wings, the Notch signalling pathway may come to play an important role in the recovery from heart attacks. In a study published today in Circulation Research, scientists at the European Molecular Biology Laboratory (EMBL) in Monterotondo, Italy, are the first to prove that this signalling pathway targets heart muscle cells and thus reveal its crucial role in heart development and repair.
The Notch pathway is a molecular mechanism through which cells communicate with each other. Scientists in Nadia Rosenthal's group at EMBL used sophisticated genetic mouse models to uncover critical roles for this pathway in heart muscle cells. When they inactivated Notch specifically in the heart muscle precursor cells of early mouse embryos, the scientists discovered that the mice developed heart defects. Curiously, increasing Notch signalling in the heart muscle cells of older embryos had the same detrimental effect, uncovering different requirements for Notch as development proceeds.
"The cardiac malformations we observed are characteristic of Alagille syndrome, a human congenital disorder," said first author Paschalis Kratsios. "Therefore, our findings could help to explain the cardiac symptoms associated with Alagille syndrome and related forms of congenital heart disease."
Intriguingly, the scientists were able to improve the cardiac function and survival rate of adult mice that had suffered heart attacks by re-activating Notch, suggesting new therapeutic approaches to help the heart recover from damage.
"Overall, these results highlight the importance of timing and context in biological communication mechanisms," Nadia Rosenthal concludes: "Our findings also lend support to the notion that, in certain situations, redeployment of embryonic signalling pathways could prove beneficial for tissue regeneration in the adult."
The Notch pathway is a molecular mechanism through which cells communicate with each other. Scientists in Nadia Rosenthal's group at EMBL used sophisticated genetic mouse models to uncover critical roles for this pathway in heart muscle cells. When they inactivated Notch specifically in the heart muscle precursor cells of early mouse embryos, the scientists discovered that the mice developed heart defects. Curiously, increasing Notch signalling in the heart muscle cells of older embryos had the same detrimental effect, uncovering different requirements for Notch as development proceeds.
"The cardiac malformations we observed are characteristic of Alagille syndrome, a human congenital disorder," said first author Paschalis Kratsios. "Therefore, our findings could help to explain the cardiac symptoms associated with Alagille syndrome and related forms of congenital heart disease."
Intriguingly, the scientists were able to improve the cardiac function and survival rate of adult mice that had suffered heart attacks by re-activating Notch, suggesting new therapeutic approaches to help the heart recover from damage.
"Overall, these results highlight the importance of timing and context in biological communication mechanisms," Nadia Rosenthal concludes: "Our findings also lend support to the notion that, in certain situations, redeployment of embryonic signalling pathways could prove beneficial for tissue regeneration in the adult."
пятница, 10 июня 2011 г.
In Patients With Metastatic Prostate Cancer Therapeutic Vaccine Prolongs Survival And Improves Quality Of Life
A new prostate cancer vaccine may give hope to men with metastatic prostate cancer by enabling their immune systems to fight the disease. Researchers from the University of Iowa presented data on the adenovirus/PSA (Ad/PSA) vaccine during the Annual Scientific Meeting of the American Urological Association in Orlando. In recent years, the concept of vaccine immunotherapy for advanced prostate cancer has become increasingly high profile as research has expanded. Major advances in the field have contributed significantly to the discussion of this important cancer therapy as researchers explore new ways to prolong survival and improve the quality of life in patients with metastatic disease.
Researchers present their findings in a special press conference on May 18, 2008 at 2:00 p.m.
Prostate cancer cells produce a protein known as prostate-specific antigen (PSA). The goal of immunotherapy for metastatic disease is to manipulate the body's immune system to identify and destroy these cancer cells throughout the body. The Ad/PSA vaccine was developed by inserting the PSA gene into bacteria and viruses and using immune-stimulatory deoxyribonucleic acid (DNA) to modulate the body's anti-tumor response. Enabling a patient's immune system to produce anti-antigens and attack cancer cells can improve quality of life and extend survival. Earlier studies in mice demonstrated the vaccine's efficacy as it produced strong anti-PSA and, as a result, powerful anti-prostate cancer immunity.
This Phase I clinical trial assessed the performance of the Ad/PSA vaccine in men with measurable metastatic prostate cancer. Patients with D2 or D3 cancers (median age 71, median PSA 128 ng/ml) were treated with one of three dose levels of the vaccine and were followed with physical and clinical chemistry exams at two and three weeks and two, four, eight and 12 months. Median follow up was 12 months and median survival was 18 months.
After receiving the vaccine, at least 40 percent of patients developed immune responses to PSA, with anti-PSA antibodies produced in 42 percent of patients and anti-PSA T-cell responses in 71 percent. 57 percent of patients survived longer than predicted, with doubling time increased in 48 percent. Longest survival was 71 months - nearly six years.
Lubaroff DM, Konety BR, Link BK, Ratliff TL, Madsen T, Williams R: Outcomes from a phase I trial of an adenovirus/PSA vaccine for prostate cancer. J Urol, suppl., 2008; 179: 184, abstract 526.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
Researchers present their findings in a special press conference on May 18, 2008 at 2:00 p.m.
Prostate cancer cells produce a protein known as prostate-specific antigen (PSA). The goal of immunotherapy for metastatic disease is to manipulate the body's immune system to identify and destroy these cancer cells throughout the body. The Ad/PSA vaccine was developed by inserting the PSA gene into bacteria and viruses and using immune-stimulatory deoxyribonucleic acid (DNA) to modulate the body's anti-tumor response. Enabling a patient's immune system to produce anti-antigens and attack cancer cells can improve quality of life and extend survival. Earlier studies in mice demonstrated the vaccine's efficacy as it produced strong anti-PSA and, as a result, powerful anti-prostate cancer immunity.
This Phase I clinical trial assessed the performance of the Ad/PSA vaccine in men with measurable metastatic prostate cancer. Patients with D2 or D3 cancers (median age 71, median PSA 128 ng/ml) were treated with one of three dose levels of the vaccine and were followed with physical and clinical chemistry exams at two and three weeks and two, four, eight and 12 months. Median follow up was 12 months and median survival was 18 months.
After receiving the vaccine, at least 40 percent of patients developed immune responses to PSA, with anti-PSA antibodies produced in 42 percent of patients and anti-PSA T-cell responses in 71 percent. 57 percent of patients survived longer than predicted, with doubling time increased in 48 percent. Longest survival was 71 months - nearly six years.
Lubaroff DM, Konety BR, Link BK, Ratliff TL, Madsen T, Williams R: Outcomes from a phase I trial of an adenovirus/PSA vaccine for prostate cancer. J Urol, suppl., 2008; 179: 184, abstract 526.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
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