Cor Therapeutics Inc. is set to launch Phase III trials of itsplatelet inhibitor Integrelin for use in the setting of coronaryangioplasty, the company announced Tuesday.
The randomized, double-blind, placebo-controlled trial willinvolve approximately 3,000 patients undergoing coronaryangioplasty at approximately 50 sites in the U.S. Robert Califf ofDuke University and Eric Topol of The Cleveland Clinic will bethe principal investigators of the study.
The primary clinical endpoint will be a composite of death,myocardial infarction and urgent intervention 30 daysfollowing angioplasty.
Califf presented the results of a Phase II trial of the drug foruse in coronary angioplasty in May at the Restenosis Summit Vmeeting, which was sponsored by the Cleveland Clinic HeartCenter and the Center for Thrombosis and Vascular Biology.The study showed that the drug reduced clinical events (repeatangioplasty, coronary bypass surgery, stent placement, heartattack and death) compared with placebo. It also found nodifference in moderate and severe bleeding events betweenIntegrelin and placebo, but an increase in mild bleeding eventswith Integrelin.
Integrelin inhibits GPIIb-IIIa, the receptor that mediatesplatelet aggregation that form blockages in the artery. Thecompound is also in Phase II for the treatment of unstableangina.
Integrelin is Cor's (NASDAQ:CORR) lead product. The South SanFrancisco, Calif., company also has in research and developmentthe compound Xai for venous thrombosis, a thrombin receptorantagonist program, a growth factor inhibitor program and anoral platelet aggregation inhibitor program.
Cor has an agreement with Eli Lilly and Co. to developcardiovascular products based on platelet aggregationinhibitors; it specifically excludes Integrelin, to which Lillyoriginally had the rights of first refusal for productdevelopment. -- Brenda Sandburg
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