Medicines Co. (MDCO) Releases Phase III Data for CHAMPION Program of Cangrelor

November 16, 2009 7:09 AM EST

The Medicines Company (NASDAQ: MDCO) today announced the data from 13,941 patients treated in the discontinued CHAMPION Phase III program of cangrelor. While cangrelor did not show superiority to 600 mg clopidogrel given orally for the pre-specified primary endpoint comprising death, MI, or ischemia driven revascularization (IDR) at 48 hours, full analysis of the CHAMPION program data revealed strong evidence of pharmacological effects, clinical effectiveness and suitable safety in patients undergoing percutaneous coronary intervention (PCI). In fact, cangrelor significantly reduced the composite endpoint of death, Q-wave myocardial infarction (MI) and IDR.

Two separate presentations on the results of the CHAMPION PCI and CHAMPION PLATFORM trials will be given today at the American Heart Association Scientific Sessions 2009 in Orlando, Florida, by Robert A. Harrington, M.D., Professor of Medicine at Duke University Medical Center, Director of the Duke Clinical Research Institute and Deepak L. Bhatt, M.D., M.P.H., Chief of Cardiology at the VA Boston Healthcare System, Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and the VA Boston Healthcare System. The speakers are the lead authors of two papers on these results published in the New England Journal of Medicine, which became available online today.

CHAMPION program data were analyzed after the program's discontinuation in May 2009 when 98% of targeted patients in CHAMPION PCI and 84% in CHAMPION PLATFORM had been enrolled. At that time, the program's independent interim analysis review committee reported to the company and the principal investigators that the CHAMPION PLATFORM trial was not expected to meet its primary endpoints.

Cangrelor was superior to clopidogrel (600 mg given orally before PCI) in inhibiting platelet aggregation measured by a range of laboratory tests (p-value < 0.0001) during the first 2 hours of treatment, resulting in more rapid and greater effect than that of clopidogrel. The antiplatelet effects of cangrelor are quickly reversible, enabling smooth transition to oral clopidogrel with no evidence of attenuation of clopidogrel effect.

The risk of the composite endpoint of death, Q-wave MI or IDR was 39% lower on cangrelor than on 600 mg clopidogrel given immediately before or immediately after PCI (p-value = 0.0049). Similarly, the risk of the composite endpoint of death, Q-wave MI or stent thrombosis was 45% lower (p-value = 0.0028).

In CHAMPION PCI, cangrelor was not superior to 600 mg clopidogrel loading dose in the 37% of patients who entered the trial on clopidogrel maintenance therapy. However, cangrelor was superior to a 600 mg clopidogrel loading dose in remaining 63% thienopyridine-nave patients with a relative risk reduction for death/Q-MI/IDR of 43% (p-value = 0.04). In CHAMPION PLATFORM, all patients were thienopyridine-nave and cangrelor showed a relative risk reduction for death/Q-MI/IDR of 45% (p-value = 0.0028).

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