Schering-Plough released not-bad news about its novel oral thrombin receptor antagonist (TRA), as two Phase II studies in patients with vascular disease showed that TRA does 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. The trials were conducted in Japan as part of the global registration program for TRA.
"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, M.D., 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."
The trials had the secondary objective of assessing 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. According to an SP statement, "While not powered to establish efficacy, in the acute coronary syndrome study patients undergoing percutaneous coronary intervention (PCI) treated with TRA had a statistically significant reduction in myocardial infarctions during the periprocedural period compared to standard of care alone."
The company has begun dosing in patients in the global phase III development program, which includes nearly 30,000 patients with vascular disease. The first trial, in secondary prevention, involves approximately 19,500 patients with prior myocardial infarction or stroke, as well as patients with existing peripheral arterial disease. The second trial, in acute coronary syndrome, involves approximately 10,000 patients with non-ST segment elevation acute coronary syndrome.
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