Archemix initiates Phase IIa carotid endarterectomy trial

Archemix, a biotechnology company, has initiated a Phase IIa clinical trial of its anti-von Willebrand Factor aptamer, ARC1779.

The trial is designed to evaluate the safety and efficacy of ARC1779 as a potential anti-platelet agent in patients with carotid artery disease undergoing a surgical procedure known as carotid endarterectomy, or CEA.

The recently initiated Phase IIa trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of ARC1779 in approximately 100 CEA patients at multiple centers in North America and Europe. The primary objectives of the trial will be to measure the effectiveness of ARC1779 in reducing the number of small blood clots which form immediately following the operation and then flow to the brain, and to assess the bleeding risk of ARC1779 in this setting.

Secondary objectives include evaluating the effect of ARC1779 administration on reducing the brain injury caused by the small blood clots formed immediately following the operation. The study will also assess the pharmacokinetic and pharmacodynamic profile of ARC1779.

Hugh Markus, professor of neurology and clinical neuroscience at St George’s, University of London, the lead investigator in the Phase IIa trial, said: There is an unmet medical need for anti-platelet agents that can improve the success rate for stroke prevention. Because of the unique biology of anti-von Willebrand Factor, we believe that ARC1779 can locally inhibit clot formation and reduce stroke risk, while reducing the bleeding complications that are associated with existing anti-platelet agents.