Positive Ph II safety data on S-P's TRA

US drug major Schering-Plough says that results from two randomized, double-blind, placebo-controlled Phase II studies in patients with vascular disease showed that its novel oral thrombin receptor antagonist does (TRA) not increase the rate of major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy.

"These findings confirm the results of the TRA-PCI Phase II trial, which were presented at the American College of Cardiology/i2 Summit earlier this year," said Rick Veltri, group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "We now have three Phase II trials involving a total of more than 1,200 patients with vascular disease which consistently demonstrate that TRA is well-tolerated and not associated with an increased rate of bleeding compared to patients who received standard of care therapy alone."

A secondary objective was to assess whether patients treated with TRA in addition to standard-of-care therapy had fewer major adverse cardiovascular events such as myocardial infarction compared to patients treated with the standard-of-care alone. While not powered to establish efficacy, in the acute coronary syndrome study patients undergoing percutaneous coronary intervention treated with TRA had a statistically-significant reduction in myocardial infarctions during the periprocedural period versus standard-of-care.