A preliminary analysis of the Phase II clinical data on CorTherapeutics Inc.'s anti-thrombotic compound in coronaryangioplasty indicated that the drug Integrelin reduces theincidence of clinical events (repeat angioplasty, coronarybypass surgery, stent placement, heart attack and death) ascompared to placebo, the company said Friday.
Also, there was no observed difference between Integrelin andplacebo in the incidence of moderate and severe bleedingevents.
Trial co-principal investigator Robert Califf of Duke Universitypresented the data on May 21 at the Restenosis Summit Vmeeting sponsored by the Cleveland Clinic Heart Center andThe Center for Thrombosis and Vascular Biology.
The study, which enrolled more than 150 patients, wasconducted to evaluate the safety of Integrelin -- a highlyspecific and rapidly reversible inhibitor of the glycoproteinGPIIb/IIIa, the receptor that mediates platelet aggregation --when added to current therapy of aspirin and heparin intreating patients undergoing coronary angioplasty. The idea isto prevent the occurrence of abrupt closure of the coronaryartery, which occurs in 5 percent to 8 percent of patients whohave had some sort of angioplasty.
The study, which was completed in mid-April, was notdesigned to obtain statistically significant results on clinicalbenefits. It measured the clinical endpoints (such as repeatangioplasty) during the hospital stay and 30 days later.
The incidence of clinical events in-hospital was 10.2 percent forpatients receiving placebo, and 7.9 percent for those receivingIntegrelin, explained Vaughn Kailian, Cor's president and chiefexecutive officer. Thirty days later, the percentages were 11.1percent and 8.1 percent, respectively. As far as bleedingincidents, the only difference seemed to be in the incidence ofmild bleeding, where the Integrelin-treated group had morebleeding (29 percent) than the placebos (14 percent).
Cor Therapeutics (NASDAQ:CORR) of South San Francisco, Calif.,plans to present a detailed analysis of the Phase II trial data atthe American Heart Association meeting in November, Kailiantold BioWorld. "This is just one step in a long clinical program."
-- Jennifer Van Brunt Senior Editor
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