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Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study
Date:3/12/2009

A Phase II Study Published in The Lancet of Fast-Tracked Antiplatelet Agent Showed No Increase in TIMI Major and Minor Bleeding and was Well Tolerated When Given With Standard Platelet Therapy

KENILWORTH, N.J., March 12 /PRNewswire-FirstCall/ -- Results of a Schering-Plough Corporation (NYSE: SGP) Phase II trial of SCH 530348, a novel oral thrombin receptor antagonist (TRA), were published today in The Lancet and demonstrated that the investigational antiplatelet compound met its primary endpoints of safety and tolerability. TRA showed no increase in major and minor Thrombolysis in Myocardial Infarction (TIMI)-scale bleeding when given with current standard antiplatelet therapy (aspirin and clopidogrel) for patients undergoing percutaneous coronary intervention (PCI), commonly known as balloon angioplasty with stenting.

"The results of this study are encouraging as they support the viability of TRA as a potential new antiplatelet therapy option," said Richard Becker, MD, director of the Duke Cardiovascular Thrombosis Center and lead author of the study. "TRA appears to work in a novel way that is complementary to current antiplatelet therapies," he further commented.

Another important result from the Thrombin Receptor Antagonist Percutaneous Coronary Intervention (TRA-PCI) trial was the rate of thrombin-receptor agonist peptide (TRAP)-induced platelet aggregation inhibition, a secondary endpoint. Thrombin is the most potent platelet activator, which leads to platelet aggregation and the development of blood clots. In the study, TRA showed a much higher TRAP-induced platelet aggregation inhibition compared to standard of care alone in both loading and maintenance doses.

"In this study, TRA, when given with aspirin and clopidogrel, was able to inhibit the aggregation of platelets even when
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SOURCE Schering-Plough Corporation
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