Clinical Experts To Oversee Phase 3 Program of CGT-2168
MENLO PARK, Calif., Feb. 8 /PRNewswire/ -- Cogentus Pharmaceuticals, Inc., today named a distinguished international panel of medical experts to serve on the Scientific Steering Committee charged with overseeing COGENT, the company's global Phase 3 clinical trial program for its novel combination antiplatelet product CGT-2168.
The panel includes experts in the fields of cardiology,
gastroenterology and clinical investigation. "We are extremely pleased that
these accomplished clinical scientists will advise us on the COGENT
program. Their participation will help ensure its scientific success," said
Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D.,
Members of the COGENT Scientific Steering Committee are:
-- Dr. Deepak Bhatt, Associate Director, Cardiovascular Coordinating
Center, Cleveland Clinic, Cleveland, Ohio
-- Dr. Marc Cohen, Director of the Division of Cardiology, Newark Beth
Israel Medical Center, Newark, New Jersey
-- Dr. Byron Cryer, John C. Vanatta III Professor of Medicine and
Associate Dean for Minority Affairs, Southwestern Medical School,
-- Dr. Angel Lanas, Service of Gastroenterology, University Hospital,
-- Dr. Thomas Schnitzer, Professor of Medicine, Division of Rheumatology,
Northwestern University Feinberg School of Medicine, Chicago, Illinois
The Scientific Steering Committee will be responsible for providing scientific and clinical oversight and advice to ensure the data that emerge from the COGENT program are of the highest quality and that the highest level of scientific conduct is maintained.
The ongoing COGENT program will evaluate the efficacy and safety of Cogentus's lead product, CGT-2168, which combines the antiplatelet medicine clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix(R)) and a gastroprotectant (omeprazole).
While antiplatelet therapy has been shown to be effective in preventing major cardiovascular events, it is associated with significant gastrointestinal side effects including bleeding, which can interrupt treatment, may require hospitalization or in some cases even result in death. Bleeding from the use of the antiplatelet drugs aspirin and clopidogrel has been shown respectively to be the third and fourth most common causes of U.S. emergency room visits by older adults experiencing adverse drug events.
"It is critical that patients are able to remain on treatment," Dr. Goldsmith said. A new analysis published in this week's Journal of the American Medical Association showed that patients with acute coronary syndrome who stopped taking Plavix nearly doubled their risk of heart attack or death within the first 90 days following the end of treatment.
CGT-2168 is designed to maintain full protective cardiovascular benefits while reducing the potentially serious gastrointestinal side effects commonly associated with antiplatelet therapy. Early results with CGT-2168 show excellent absorption and metabolism of clopidogrel that are unaffected by the delayed-release omeprazole within this combination product. Cogentus believes these findings suggest the novel formulation avoids a drug-drug interaction that has been reported when the individual marketed drugs are co-administered.
"It is important for patients to receive the full cardiovascular effect of dual antiplatelet therapy while reducing gastrointestinal side effects," said Steering Committee member Dr. Marc Cohen. "The COGENT program is evaluating whether CGT-2168 will maintain the cardiovascular benefits of treatment while minimizing bleeding."
"We believe CGT-2168 has the potential to offer an effective yet safer treatment option for the millions of patients who require antiplatelet therapy. With the help of the Scientific Steering Committee, we are committed to a thorough evaluation of the potentially significant benefits of this new medicine," Dr. Goldsmith said.
COGENT stands for the Clopidogrel and the Optimization of Gastrointestinal Events Trial. The program is expected to enroll more than 4,000 patients at hundreds of sites in the United States, Canada, Europe and South America. The COGENT program is designed to measure the incidence of upper gastrointestinal bleeding and ulcers in patients who take CGT-2168 and aspirin compared with patients who take clopidogrel and aspirin. The vast majority of patients who take clopidogrel also take aspirin.
Physicians and patients interested in obtaining more information about COGENT should go to http://www.clinicaltrials.gov.
Cogentus Pharmaceuticals, Inc., of Menlo Park, CA, is a privately held specialty pharmaceutical company founded in 2006. Cogentus (http://www.cogentus.net) is committed to becoming a premier developer of innovative, fixed-dose combination prescription medicines serving unmet medical needs that drive significant commercial opportunities.
Plavix(R) is a registered trademark of Sanofi-Aventis.
|SOURCE Cogentus Pharmaceuticals, Inc.|
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