Cogentus Pharmaceuticals Names Scientific Steering Committee for Global Phase 3 Clinical Program
The panel includes experts in the fields of cardiology, gastroenterologyand clinical investigation. "We are extremely pleased that these accomplishedclinical scientists will advise us on the COGENT program. Their participationwill help ensure its scientific success," said Cogentus Chairman and ChiefExecutive Officer Mark A. Goldsmith, M.D., Ph.D.
The Scientific Steering Committee will be responsible for providingscientific and clinical oversight and advice to ensure the data that emergefrom the COGENT program are of the highest quality and that the highest levelof scientific conduct is maintained.
The ongoing COGENT program will evaluate the efficacy and safety ofCogentus's lead product, CGT-2168, which combines the antiplatelet medicineclopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventisas Plavix(R)) and a gastroprotectant (omeprazole).
While antiplatelet therapy has been shown to be effective in preventingmajor cardiovascular events, it is associated with significantgastrointestinal side effects including bleeding, which can interrupttreatment, may require hospitalization or in some cases even result in death.Bleeding from the use of the antiplatelet drugs aspirin and clopidogrel hasbeen 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 theAmerican Medical Association showed that patients with acute coronary syndromewho stopped taking Plavix nearly doubled their risk of heart attack or deathwithin the first 90 days following the end of treatment.
CGT-2168 is designed to maintain full protective cardiovascular benefitswhile reducing the potentially serious gastrointestinal side effects commonlyassociated with antiplatelet therapy. Early results with CGT-2168 showexcellent absorption and metabolism of clopidogrel that are unaffected by thedelayed-release omeprazole within this combination product. Cogentus believesthese findings suggest the novel formulation avoids a drug-drug interactionthat has been reported when the individual marketed drugs are co-administered.
"It is important for patients to receive the full cardiovascular effect ofdual antiplatelet therapy while reducing gastrointestinal side effects," saidSteering Committee member Dr. Marc Cohen. "The COGENT program is evaluatingwhether CGT-2168 will maintain the cardiovascular benefits of treatment whileminimizing bleeding."
"We believe CGT-2168 has the potential to offer an effective yet safertreatment option for the millions of patients who require antiplatelettherapy. With the help of the Scientific Steering Committee, we are committedto a thorough evaluation of the potentially significant benefits of this newmedicine," Dr. Goldsmith said.
COGENT stands for the Clopidogrel and the Optimization of GastrointestinalEvents Trial. The program is expected to enroll more than 4,000 patients athundreds of sites in the United States, Canada, Europe and South America. TheCOGENT program is designed to measure the incidence of upper gastrointestinalbleeding and ulcers in patients who take CGT-2168 and aspirin compared withpatients who take clopidogrel and aspirin. The vast majority of patients whotake clopidogrel also take aspirin.
Physicians and patients interested in obtaini
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