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
вторник, 14 июня 2011 г.
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.
четверг, 9 июня 2011 г.
Enrollment In Amoxicillin PULSYS Phase III Trial Completed
Advancis
Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today
announced that it has completed enrollment in the Company's Amoxicillin
PULSYS Phase III clinical trial for the treatment of
pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis
concluded enrollment with a total of 620 adult/adolescent patients as of
close-of-business May 31, 2006.
Advancis' adult and adolescent pivotal program is designed as a 600-
patient, double-blind, double-dummy, non-inferiority Phase III trial and
began on November 9, 2005. Over the coming weeks, patients will complete
their treatment and follow-up visits, and Advancis and its clinical
research organization will collect and analyze the clinical data. The
Company expects to publicly report top-line results around mid-August 2006.
If the trial is successful, Advancis expects to file a 505(b)(2) New Drug
Application (NDA) with the U.S. Food and Drug Administration for the
product early in the first quarter of 2007.
"We are very pleased to have completed enrollment in our adult and
adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D.,
Advancis president and CEO. "We are hopeful that, if successful,
Amoxicillin PULSYS will provide physicians a tool to deliver the
established safety and efficacy of amoxicillin in the first and only
once-daily presentation in the U.S."
Advancis is comparing its Amoxicillin PULSYS dosage form for the
treatment of pharyngitis/tonsillitis in adults delivered in a once-daily,
775 milligram tablet for a period of 10 days to 250 milligrams of
penicillin dosed four times daily, for a total of one gram per day, for 10
days. The primary endpoint for the study is bacterial eradication, as
measured by throat cultures obtained both before and after treatment.
More than 59 million prescriptions for amoxicillin were written in 2005
with total retail sales of approximately $640 million. Amoxicillin is
indicated for a broad range of infections, and is commonly prescribed as a
first-line therapy for common infections such as otitis media (middle ear
infection), pharyngitis (sore throat), and sinusitis (sinus infection).
According to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.
ABOUT ADVANCIS PHARMACEUTICAL:
Advancis Pharmaceutical Corporation (Nasdaq: AVNC) is a pharmaceutical
company focused on the development and commercialization of anti-infective
drug products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing a portfolio of
anti-infective drugs based on its novel biological finding that bacteria
exposed to antibiotics in frontloaded staccato bursts, or "pulses," are
killed more efficiently and effectively than those under standard treatment
regimens. Based on this finding, Advancis has developed a proprietary,
once-a-day pulsatile delivery technology called PULSYS. By examining the
resistance patterns of bacteria and applying its delivery technologies,
Advancis has the potential to redefine infectious disease therapy and
significantly improve drug efficacy, shorten length of therapy, and reduce
drug resistance versus currently available antibacterial products. For more
on Advancis, please visit advancispharm.
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements are based on Advancis' current expectations and assumptions.
These statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual results to
differ materially from those anticipated. The words, "believe," "expect,"
"intend," "anticipate," "plan," "hope," and variations of such words, and
similar expressions identify forward-looking statements, but their absence
does not mean that the statement is not forward-looking. Statements in this
announcement that are forward- looking include, but are not limited to,
statements about the Company's future development plans, clinical trials,
and financial results. The actual results realized by Advancis could differ
materially from these forward-looking statements, depending in particular
upon the risks and uncertainties described in the Company's filings with
the Securities and Exchange Commission. These include, without limitation,
risks and uncertainties relating to the Company's financial results and the
ability of the Company to (1) reach profitability, (2) prove that the
preliminary findings for its product candidates are valid, (3) receive
required regulatory approvals, (4) successfully conduct clinical trials in
a timely manner, (5) establish its competitive position for its products,
(6) develop and commercialize products that are superior to existing or
newly developed competitor products, (7) develop products without any
defects, (8) have sufficient capital resources to fund its operations, (9)
protect its intellectual property rights and patents, (10) implement its
sales and marketing strategy, (11) successfully attract and retain
collaborative partners, (12) successfully develop, receive regulatory
approval, and commercialize any new Keflex products, and (13) retain its
senior management and other personnel. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis undertakes no
obligation to update or revise the information in this announcement,
whether as a result of new information, future events or circumstances or
otherwise.
Advancis Pharmaceutical Corporation
advancispharm/
Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today
announced that it has completed enrollment in the Company's Amoxicillin
PULSYS Phase III clinical trial for the treatment of
pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis
concluded enrollment with a total of 620 adult/adolescent patients as of
close-of-business May 31, 2006.
Advancis' adult and adolescent pivotal program is designed as a 600-
patient, double-blind, double-dummy, non-inferiority Phase III trial and
began on November 9, 2005. Over the coming weeks, patients will complete
their treatment and follow-up visits, and Advancis and its clinical
research organization will collect and analyze the clinical data. The
Company expects to publicly report top-line results around mid-August 2006.
If the trial is successful, Advancis expects to file a 505(b)(2) New Drug
Application (NDA) with the U.S. Food and Drug Administration for the
product early in the first quarter of 2007.
"We are very pleased to have completed enrollment in our adult and
adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D.,
Advancis president and CEO. "We are hopeful that, if successful,
Amoxicillin PULSYS will provide physicians a tool to deliver the
established safety and efficacy of amoxicillin in the first and only
once-daily presentation in the U.S."
Advancis is comparing its Amoxicillin PULSYS dosage form for the
treatment of pharyngitis/tonsillitis in adults delivered in a once-daily,
775 milligram tablet for a period of 10 days to 250 milligrams of
penicillin dosed four times daily, for a total of one gram per day, for 10
days. The primary endpoint for the study is bacterial eradication, as
measured by throat cultures obtained both before and after treatment.
More than 59 million prescriptions for amoxicillin were written in 2005
with total retail sales of approximately $640 million. Amoxicillin is
indicated for a broad range of infections, and is commonly prescribed as a
first-line therapy for common infections such as otitis media (middle ear
infection), pharyngitis (sore throat), and sinusitis (sinus infection).
According to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.
ABOUT ADVANCIS PHARMACEUTICAL:
Advancis Pharmaceutical Corporation (Nasdaq: AVNC) is a pharmaceutical
company focused on the development and commercialization of anti-infective
drug products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing a portfolio of
anti-infective drugs based on its novel biological finding that bacteria
exposed to antibiotics in frontloaded staccato bursts, or "pulses," are
killed more efficiently and effectively than those under standard treatment
regimens. Based on this finding, Advancis has developed a proprietary,
once-a-day pulsatile delivery technology called PULSYS. By examining the
resistance patterns of bacteria and applying its delivery technologies,
Advancis has the potential to redefine infectious disease therapy and
significantly improve drug efficacy, shorten length of therapy, and reduce
drug resistance versus currently available antibacterial products. For more
on Advancis, please visit advancispharm.
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements are based on Advancis' current expectations and assumptions.
These statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual results to
differ materially from those anticipated. The words, "believe," "expect,"
"intend," "anticipate," "plan," "hope," and variations of such words, and
similar expressions identify forward-looking statements, but their absence
does not mean that the statement is not forward-looking. Statements in this
announcement that are forward- looking include, but are not limited to,
statements about the Company's future development plans, clinical trials,
and financial results. The actual results realized by Advancis could differ
materially from these forward-looking statements, depending in particular
upon the risks and uncertainties described in the Company's filings with
the Securities and Exchange Commission. These include, without limitation,
risks and uncertainties relating to the Company's financial results and the
ability of the Company to (1) reach profitability, (2) prove that the
preliminary findings for its product candidates are valid, (3) receive
required regulatory approvals, (4) successfully conduct clinical trials in
a timely manner, (5) establish its competitive position for its products,
(6) develop and commercialize products that are superior to existing or
newly developed competitor products, (7) develop products without any
defects, (8) have sufficient capital resources to fund its operations, (9)
protect its intellectual property rights and patents, (10) implement its
sales and marketing strategy, (11) successfully attract and retain
collaborative partners, (12) successfully develop, receive regulatory
approval, and commercialize any new Keflex products, and (13) retain its
senior management and other personnel. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis undertakes no
obligation to update or revise the information in this announcement,
whether as a result of new information, future events or circumstances or
otherwise.
Advancis Pharmaceutical Corporation
advancispharm/
среда, 8 июня 2011 г.
Vertex Pharmaceuticals Initiates Phase I Development For VX-770 In Cystic Fibrosis
Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has
initiated a Phase I clinical study for VX-770, a novel, oral drug candidate
that specifically targets a key mechanism underlying cystic fibrosis (CF).
The study will evaluate the safety, tolerability and pharmacokinetics of
escalating single and multiple doses of VX-770 in healthy volunteers, and
also will evaluate single doses of VX-770 in patients with CF. The study is
expected to enroll more than 50 individuals. In March 2006, Vertex and
Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) entered into a
collaboration to accelerate clinical development of VX-770. CFFT is the
nonprofit drug discovery and development affiliate of the Cystic Fibrosis
Foundation. Vertex retains worldwide rights to develop and commercialize
VX-770.
"This first clinical study for VX-770 signifies an important milestone
in the productive collaborative history that we have shared with Vertex in
the discovery of novel CF therapies," said Robert J. Beall, Ph.D.,
President and Chief Executive Officer of the Cystic Fibrosis Foundation and
CFFT. "We believe that compounds such as VX-770 have great potential to
change the course of CF, and we are pleased to support the accelerated
development of VX-770 in early clinical studies."
"VX-770 is the first drug candidate to have emerged from our innovative
CF research efforts, and the initiation of this Phase I study represents an
exciting new stage in the development of this compound," said John Alam,
M.D., Executive Vice President, Medicines Development, and Chief Medical
Officer of Vertex. "Laboratory results for VX-770 have been highly
encouraging and support the initiation of this first clinical study. We
look forward to evaluating VX-770 in both healthy volunteers and patients
with CF in the coming months to determine the next steps for the VX-770
development program."
Study Design
The Phase I study for VX-770 announced today is expected to enroll more
than 50 individuals, including healthy volunteers and patients with CF.
Dosing has been initiated in the first cohort of healthy volunteers, and is
expected to progress to patients with CF later this year. Healthy
volunteers in the Phase I study will receive escalating doses of VX-770 for
treatment durations of up to 14 days, and patients with CF will receive
single doses of VX-770.
Fast Track Designation for VX-770
Vertex also today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to VX-770. The FDA granted Fast
Track designation to VX-770 for the following reasons:
Cystic fibrosis (CF) is a serious and life-threatening illness in which
mucus plugging, infection, and inflammation in the lungs lead to a
decline in pulmonary function and significant morbidity and mortality.
VX-770 is intended to preserve pulmonary function, decrease morbidity,
and prolong survival in patients with CF by decreasing cycles of mucus
plugging, infection, and inflammation in the lungs.
Under the FDA Modernization Act of 1997, Fast Track designation
indicates that the FDA will facilitate the development and may expedite the
review of a drug if it is intended for the treatment of a serious or
life-threatening condition and demonstrates the potential to address an
unmet medical need for such a condition.
About VX-770
VX-770 was advanced into preclinical development based on a successful
research collaboration with CFFT that incorporated capabilities and
proprietary research from Vertex's San Diego research site. VX-770 may act
to restore the function of the cystic fibrosis transmembrane conductance
regulator (CFTR) protein, the defective cell membrane protein responsible
for the progression of CF. Defects in the CFTR protein affect the transport
of chloride and other ions across cells, and lead to the accumulation of
thick, sticky mucus in the lungs of patients with CF. This mucus fosters
chronic infection and inflammation, and results in irreversible lung
damage. Potentiator compounds such as VX-770 are designed to increase the
probability that the CFTR channel is open, which could result in an
increase in chloride transport across the cell surface in some patients. In
laboratory experiments, using cells from patients with CF where CFTR
proteins are present on the cell surface, VX-770 has restored the gating
activity of defective CFTR channels.
Collaborative History with CFFT
Vertex initiated its CF research program in May 2000 in collaboration
with CFFT, which offers special expertise and experience in CF drug
discovery and development. Vertex and CFFT expanded the agreement in May
2004, and in March 2006, entered into a new collaboration for the
accelerated development of VX- 770. Under the collaboration, CFFT will
provide to Vertex approximately $13.3 million to support clinical
development of VX-770 through the fourth quarter of 2007. In addition to
the development collaboration for VX-770, in January 2006, Vertex and CFFT
entered into an expanded research collaboration to discover novel compounds
known as correctors, which may work by increasing the number of CFTR
channels on the cell surface. To date, CFFT has provided to Vertex more
than $40 million for CF research.
About Cystic Fibrosis and the Cystic Fibrosis Foundation
Cystic fibrosis is a genetic disease affecting approximately 30,000
people in the United States. A defect in the CFTR gene causes the body to
produce abnormally thick, sticky mucus that leads to chronic,
life-threatening lung infections and impairs digestion. When the CF
Foundation was established in 1955, few children lived to attend elementary
school. Today, because of research and care supported by the CF Foundation
with money raised through donations from families, corporations and
foundations -- the median predicted age of survival for people with CF is
now more than 36 years.
The Cystic Fibrosis Foundation, headquartered in Bethesda, MD, is a
donor-supported, nonprofit organization committed to finding therapies and
ultimately a cure for CF, and to improving the lives of those with the
disease. For more information on CF and the programs of the CF Foundation,
call (800) FIGHT CF or visit cff.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that Vertex expects (i) that the Phase I clinical study for
VX-770 is expected to enroll more than 50 individuals; (ii) that the study
will evaluate the safety, tolerability and pharmacokinetics of escalating
single and multiple doses of VX-770 in healthy volunteers and single doses
of VX-770 in patients with CF; (iii) that compounds such as VX-770 have the
potential to change the course of CF; (iv) that it will evaluate VX-770 in
the coming months to determine the next steps for the VX-770 development
program; (v) to begin dosing VX-770 in patients with CF later this year;
and (vi) VX-770 may act to restore the function of the cystic fibrosis
transmembrane conductance regulator (CFTR) protein. While management makes
its best efforts to be accurate in making forward-looking statements, such
statements are subject to risks and uncertainties that could cause Vertex's
actual results to vary materially. These risks and uncertainties include,
among other things, the possibility that CFFT could terminate its financial
support under its agreements with Vertex early, risks that efforts to
develop VX-770 may not proceed due to financial, technical, scientific,
commercial or other reasons, that clinical trials may not proceed as
planned due to technical, scientific, supply or patient enrollment issues,
that actual clinical studies of VX-770 will not reflect the results
obtained in pre-clinical and nonclinical testing, and other risks listed
under Risk Factors in Vertex's Form 10-K filed with the Securities and
Exchange Commission on March 16, 2006.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at vrtx.
Vertex Pharmaceuticals Incorporated
vrtx
View drug information on Lexiva.
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has
initiated a Phase I clinical study for VX-770, a novel, oral drug candidate
that specifically targets a key mechanism underlying cystic fibrosis (CF).
The study will evaluate the safety, tolerability and pharmacokinetics of
escalating single and multiple doses of VX-770 in healthy volunteers, and
also will evaluate single doses of VX-770 in patients with CF. The study is
expected to enroll more than 50 individuals. In March 2006, Vertex and
Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) entered into a
collaboration to accelerate clinical development of VX-770. CFFT is the
nonprofit drug discovery and development affiliate of the Cystic Fibrosis
Foundation. Vertex retains worldwide rights to develop and commercialize
VX-770.
"This first clinical study for VX-770 signifies an important milestone
in the productive collaborative history that we have shared with Vertex in
the discovery of novel CF therapies," said Robert J. Beall, Ph.D.,
President and Chief Executive Officer of the Cystic Fibrosis Foundation and
CFFT. "We believe that compounds such as VX-770 have great potential to
change the course of CF, and we are pleased to support the accelerated
development of VX-770 in early clinical studies."
"VX-770 is the first drug candidate to have emerged from our innovative
CF research efforts, and the initiation of this Phase I study represents an
exciting new stage in the development of this compound," said John Alam,
M.D., Executive Vice President, Medicines Development, and Chief Medical
Officer of Vertex. "Laboratory results for VX-770 have been highly
encouraging and support the initiation of this first clinical study. We
look forward to evaluating VX-770 in both healthy volunteers and patients
with CF in the coming months to determine the next steps for the VX-770
development program."
Study Design
The Phase I study for VX-770 announced today is expected to enroll more
than 50 individuals, including healthy volunteers and patients with CF.
Dosing has been initiated in the first cohort of healthy volunteers, and is
expected to progress to patients with CF later this year. Healthy
volunteers in the Phase I study will receive escalating doses of VX-770 for
treatment durations of up to 14 days, and patients with CF will receive
single doses of VX-770.
Fast Track Designation for VX-770
Vertex also today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to VX-770. The FDA granted Fast
Track designation to VX-770 for the following reasons:
Cystic fibrosis (CF) is a serious and life-threatening illness in which
mucus plugging, infection, and inflammation in the lungs lead to a
decline in pulmonary function and significant morbidity and mortality.
VX-770 is intended to preserve pulmonary function, decrease morbidity,
and prolong survival in patients with CF by decreasing cycles of mucus
plugging, infection, and inflammation in the lungs.
Under the FDA Modernization Act of 1997, Fast Track designation
indicates that the FDA will facilitate the development and may expedite the
review of a drug if it is intended for the treatment of a serious or
life-threatening condition and demonstrates the potential to address an
unmet medical need for such a condition.
About VX-770
VX-770 was advanced into preclinical development based on a successful
research collaboration with CFFT that incorporated capabilities and
proprietary research from Vertex's San Diego research site. VX-770 may act
to restore the function of the cystic fibrosis transmembrane conductance
regulator (CFTR) protein, the defective cell membrane protein responsible
for the progression of CF. Defects in the CFTR protein affect the transport
of chloride and other ions across cells, and lead to the accumulation of
thick, sticky mucus in the lungs of patients with CF. This mucus fosters
chronic infection and inflammation, and results in irreversible lung
damage. Potentiator compounds such as VX-770 are designed to increase the
probability that the CFTR channel is open, which could result in an
increase in chloride transport across the cell surface in some patients. In
laboratory experiments, using cells from patients with CF where CFTR
proteins are present on the cell surface, VX-770 has restored the gating
activity of defective CFTR channels.
Collaborative History with CFFT
Vertex initiated its CF research program in May 2000 in collaboration
with CFFT, which offers special expertise and experience in CF drug
discovery and development. Vertex and CFFT expanded the agreement in May
2004, and in March 2006, entered into a new collaboration for the
accelerated development of VX- 770. Under the collaboration, CFFT will
provide to Vertex approximately $13.3 million to support clinical
development of VX-770 through the fourth quarter of 2007. In addition to
the development collaboration for VX-770, in January 2006, Vertex and CFFT
entered into an expanded research collaboration to discover novel compounds
known as correctors, which may work by increasing the number of CFTR
channels on the cell surface. To date, CFFT has provided to Vertex more
than $40 million for CF research.
About Cystic Fibrosis and the Cystic Fibrosis Foundation
Cystic fibrosis is a genetic disease affecting approximately 30,000
people in the United States. A defect in the CFTR gene causes the body to
produce abnormally thick, sticky mucus that leads to chronic,
life-threatening lung infections and impairs digestion. When the CF
Foundation was established in 1955, few children lived to attend elementary
school. Today, because of research and care supported by the CF Foundation
with money raised through donations from families, corporations and
foundations -- the median predicted age of survival for people with CF is
now more than 36 years.
The Cystic Fibrosis Foundation, headquartered in Bethesda, MD, is a
donor-supported, nonprofit organization committed to finding therapies and
ultimately a cure for CF, and to improving the lives of those with the
disease. For more information on CF and the programs of the CF Foundation,
call (800) FIGHT CF or visit cff.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that Vertex expects (i) that the Phase I clinical study for
VX-770 is expected to enroll more than 50 individuals; (ii) that the study
will evaluate the safety, tolerability and pharmacokinetics of escalating
single and multiple doses of VX-770 in healthy volunteers and single doses
of VX-770 in patients with CF; (iii) that compounds such as VX-770 have the
potential to change the course of CF; (iv) that it will evaluate VX-770 in
the coming months to determine the next steps for the VX-770 development
program; (v) to begin dosing VX-770 in patients with CF later this year;
and (vi) VX-770 may act to restore the function of the cystic fibrosis
transmembrane conductance regulator (CFTR) protein. While management makes
its best efforts to be accurate in making forward-looking statements, such
statements are subject to risks and uncertainties that could cause Vertex's
actual results to vary materially. These risks and uncertainties include,
among other things, the possibility that CFFT could terminate its financial
support under its agreements with Vertex early, risks that efforts to
develop VX-770 may not proceed due to financial, technical, scientific,
commercial or other reasons, that clinical trials may not proceed as
planned due to technical, scientific, supply or patient enrollment issues,
that actual clinical studies of VX-770 will not reflect the results
obtained in pre-clinical and nonclinical testing, and other risks listed
under Risk Factors in Vertex's Form 10-K filed with the Securities and
Exchange Commission on March 16, 2006.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at vrtx.
Vertex Pharmaceuticals Incorporated
vrtx
View drug information on Lexiva.
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