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Cogentus Pharmaceuticals Names Scientific Steering Committee for Global Phase 3 Clinical Program
Date:2/8/2008

ficacy 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
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SOURCE Cogentus Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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