The Medicines Company has announced that the first patient has been treated in a phase III clinical trial called Champion platform to evaluate the safety and efficacy of cangrelor, a fast-acting, reversible intravenous (IV) antiplatelet agent for preventing platelet activation and aggregation during the clotting process.
Champion platform is a randomised, double-blind, placebo-controlled, parallel group study with a planned enrollment estimated at 4,400 patients.
The primary objective of this study is to demonstrate that the efficacy of cangrelor plus usual care is superior to placebo plus usual care in patients requiring percutaneous coronary intervention (PCI). PCI, often referred to as coronary angioplasty, is a procedure conducted to clear blockages in arteries around the heart. Usual patient care during PCI includes a mix of IV and oral therapies that target the inhibition of blood clotting factors such as thrombin or platelets. The trials' co-primary investigators are Deepak Bhatt, MD of The Cleveland Clinic Foundation and Robert Harrington, MD of the Duke Clinical Research Institute.
The first patient was enrolled at the Dakota Clinic/Innovis Health, in Fargo, ND. The site's principal investigator is Dr Edmund Fiksinski.
"With the commencement of Champion platform, The Medicines Company has accomplished a key goal of initiating both cangrelor phase III clinical trials in 2006," said John Kelley, president and chief operating officer of The Medicines Company. "We believe our acute care franchise is taking shape nicely: Angiomax (bivalirudin) is growing in commercial strength, and our two IV acute care pipeline candidates, clevidipine and cangrelor moving forward as planned."
The cangrelor phase III programme is comprised of two multinational trials to evaluate cangrelor's effectiveness and safety in preventing ischemic events in patients who require PCI. The company announced in April the start of patient enrollment of the Champion PCI trial, which has a planned enrollment estimated at 9,000 patients. The Medicines Company expects patient enrollment in both phase III trials to be completed in 2008.
If the trials are successfully completed and cangrelor receives regulatory clearance, the Company believes cangrelor will be the first IV platelet inhibitor to market that binds directly to the P2Y12 receptor, a clinically validated target to treat or prevent arterial thrombosis in patients undergoing PCI.
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The company markets Angiomax (bivalirudin) in the US and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart.