Worldwide COGENT-1 Study of CGT-2168 Expands to Europe; Focus on Reducing
Gastrointestinal Side Effects of Antiplatelet Therapy
MENLO PARK, Calif., June 16 /PRNewswire/ -- Cogentus Pharmaceuticals, Inc. today announced that the first patient has been enrolled in Europe in the company's pivotal Phase 3 study of its novel combination medicine CGT-2168. The patient entered the COGENT-1 study at the Zadebie cardiology clinic in Skierniewice, Poland.
The study, which began in North America in January, is evaluating the antiplatelet medicine CGT-2168, a combination of clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix(R)) and a gastroprotectant (omeprazole) in a single pill. Developed by Cogentus, CGT-2168 is designed to provide cardiovascular benefits while reducing potentially serious gastrointestinal side effects commonly associated with dual antiplatelet therapy.
Antiplatelet therapy is an integral part of treating patients with acute coronary syndrome and has been shown to be effective in preventing major cardiovascular events. However, the combination of clopidogrel and aspirin is associated with gastrointestinal bleeding, which in some cases requires hospitalization and can even result in death.
"Millions of cardiac patients in Europe have benefited from antiplatelet therapy," said Gilles Montalescot, M.D., Ph.D., Professor of Cardiology at the Institut de Cardiologie, Pitie-Salpetriere Hospital in Paris. "It is important that our patients have access to innovative new treatment options that can enhance compliance with treatment and provide positive outcomes. We look forward to being part of the COGENT program."
Among the estimated 4,000 patients worldwide who will participate in the study, approximately half will receive clopidogrel and aspirin; the other half will receive CGT-2168 (clopidogrel plus omeprazole) and aspirin. Patients will be assessed regularly for any gastrointestinal side effects such as bleeding and ulcers as well as receive ongoing monitoring of their cardiovascular status.
"This is yet another important milestone for our company," said Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D., Ph.D. "COGENT has been very well received by the medical community in North America, with strong enrollment. Now we will begin to gather important data from investigators in Europe and broaden the patient base of the study."
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.
COGENT stands for Clopidogrel and the Optimization of Gastrointestinal Events Trial. In addition to North America and Europe, the COGENT program also will include patients in South America, where clinical sites are expected to come on line later this year.
Plavix(R) is a registered trademark of Sanofi-Aventis.
|SOURCE Cogentus Pharmaceuticals, Inc.|
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