The Medicines Company (NASDAQ: MDCO) announced that it is discontinuing its Phase 3 CHAMPION clinical trial program of cangrelor in patients undergoing percutaneous coronary intervention (PCI).
Cangrelor is an investigational intravenous antiplatelet agent exclusively licensed in December 2003 from AstraZeneca.
The program’s independent Interim Analysis Review Committee (IARC), after conferring with the Drug Safety Monitoring Board, reported to the Company that the CHAMPION-PLATFORM trial would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval. This placebo-controlled trial compared treatment with cangrelor (in combination with usual care) to usual care in patients who require PCI.
The IARC also reported to the Company that, based on updated information, the CHAMPION-PCI trial, a clinical trial comparing treatment with cangrelor to clopidogrel (600 mg loading dose) in patients who require PCI, showed no significant differences in measures of clinical effectiveness.
Safety findings for the program were consistent with those expected from short-term P2Y12 platelet inhibition and included an increase in minor bleeding among patients given cangrelor in comparison to placebo, but not in comparison to clopidogrel.
Based on the totality of these data, the IARC has recommended that enrollment in both trials be discontinued and that all remaining data should be collected and analyzed. The Company is in the process of notifying the investigators and regulatory agencies of the discontinuation of the CHAMPION program.
The IARC also recommended that the Company should consider focusing on short-term use of cangrelor in settings where oral drugs cannot be used or when a short half-life is highly desirable. The Company had previously begun studying cangrelor in such a setting. This research, known as the BRIDGE study aims to establish the dosage of cangrelor that achieves greater than or equal to 60% inhibition of platelet aggregation for five days. The Company plans to enroll approximately 200 patients who discontinue clopidogrel in preparation for cardiac surgery. The aim is to show safe “bridging” of patients during the pre- and post-surgical period of risk. If successful, this approach may form the basis for subsequent regulatory filings.
The Company noted that the discontinuation of the CHAMPION program will result in cost savings of approximately $5 million in 2009.
Source: The Medicines Company, USA