Cangrelor

Product Overview

Cangrelor is an investigational antiplatelet agent undergoing testing to enable safe bridging of patients undergoing surgery. The safety and efficacy of cangrelor is not established by the FDA for any use; however, studies are currently underway to examine the safety and efficacy of cangrelor.

Cangrelor was exclusively licensed in December 2003 from AstraZeneca. Under the terms of our agreement with AstraZeneca, The Medicines Company will have exclusive license rights to develop, market and sell cangrelor worldwide, excluding Japan, China, Korea, Taiwan and Thailand.

Clinical Trials Overview

In total, cangrelor has been studied in approximately 14,400 patients in six Phase I studies, four Phase II studies and two Phase III studies, to date.

Early Development

These early clinical studies consist of Phase II clinical trials of cangrelor conducted by AstraZeneca prior to licensing this product candidate to us, and a 40-person clinical trial that MDCO conducted in healthy volunteers to identify a dosing strategy for use of cangrelor. [1,2]

Based on input from our hospital customers in the cardiac catheterization laboratory, there may be limitations in current oral therapies in the acute care setting which may include delayed onset, prolonged effect and unpredictable effect. This has created a need for an intravenous platelet inhibitor that acts quickly, is cleared from the bloodstream rapidly and enables rapid recovery of platelet function.

Clinical Trials

We announced the discontinuation of the Phase III CHAMPION clinical trial program of cangrelor on May 13, 2009.  The interim analyses indicate the CHAMPION program would not meet efficacy endpoints.

The Company is studying cangrelor in the BRIDGE trial which aims to establish the dosage of cangrelor that achieves > 60% inhibition of platelet aggregation for five days.  The BRIDGE study is a Phase II clinical trial with plans to enroll approximately 200 patients.  The purpose is to show safe “bridging” of patients during the pre- and post-surgical period of risk.

Mechanism of Action

Cangrelor, formerly denoted as AR-C69931MX, is a short-acting, potent, competitive P2Y12 platelet receptor antagonist. P2Y12 receptors are highly expressed on the surface of platelets and cangrelor is specific for this receptor. [3] 

References:

1. Data on File, The Medicines Company
2. Greenbaum AB, Grines CL, Bittl JA, et al. Initial experience with an intravenous P2Y12 platelet receptor antagonist in patients undergoing percutaneous coronary intervention: results from a 2-part, phase II, multicenter, randomized, placebo- and active-controlled trial. Am Heart J. 2006;151:689.e1-689e10.
3. Nassim MA, Sanderson JB, Clarke C, et al.  Investigation of the novel P2T receptor antagonist AR C69931MX on ex vivo adenosine diphosphate induced platelet aggregation and bleeding time in healthy volunteers.  J Am Coll Cardiol. 1999;33(2 Suppl A):255A