Medicines Co. Enrolls First Patient In Phase III Trial Testing Angiomax

(RTTNews) - Medicines Co. (MDCO) said it has completed two pharmacodynamic studies assessing the transition of its investigational acute intravenous antiplatelet agent, cangrelor, to chronic oral therapy with ticagrelor or prasugrel in coronary artery disease patients. Three prior trials evaluated the transition from cangrelor to oral clopidogrel in 25,000 CAD patients undergoing percutaneous intervention or PCI.

Ticagrelor and prasugrel are the newest commercially available agents, inhibiting platelets through the P2Y12 receptor, the same receptor that is inhibited by cangrelor. These agents are administered with the aim of reducing the risk of thrombotic events during and after PCI.

The ticagrelor and prasugrel transition trials were each conducted in 12 CAD patients to test the consistency of inhibition of platelet aggregation when oral ticagrelor or prasugrel were administered during or immediately after cangrelor infusion. These pharmacodynamic trials' purpose was to show that patients treated with IV cangrelor can be directly transitioned to the oral drug without a significant decrease in the extent of inhibition of platelet aggregation, the company added.

The new pharmacodynamic studies add to clinical data from the CHAMPION PHOENIX study that exhibit that transition from cangrelor to clopidogrel 600mg administered immediately after cessation of the cangrelor infusion reduces significantly thrombotic events at 48 hours, versus clopidogrel alone.

Separately, the firm has enrolled the first patient in a Phase III trial comparing the anticoagulant Angiomax to unfractionated heparin in patients undergoing peripheral endovascular intervention. The Endomax Trial is the first randomized, double blind, trial to study pharmacology in patients undergoing Peripheral Endovascular Intervention or PEI.

PEI is performed in about 500,000 patients in the U.S. every year. Currently, Angiomax is approved for angioplasty, also called percutaneous coronary intervention or PCI. The Medicines Co. plans to pursue labeling expansion in the PEI setting.

The primary objective is to show that anticoagulation with bivalirudin results in fewer major bleeding complications compared with UFH in subjects undergoing PEI, while the secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction, stroke and/or transient ischemic attack, amputation, unplanned repeat revascularization, and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.