NEUROBIOLOGICAL TECHNOLOGIES TO BEGIN TRIAL OF ANTICOAGULANT

Neurobiological Technologies has completed its the site selection for its first global Phase III trial for Viprinex (ancrod injection) in acute ischemic stroke.

The clinical program includes two double-blind, randomized, placebo-controlled trials, ASP-I and ASP-II. Patients who qualify for enrollment into the clinical trials will receive a 3-hour intravenous infusion of Viprinex or placebo within 6 hours of stroke onset. Each trial is planned to enroll 650 patients. The company expects that the trials will be conducted at up to 130 sites and that 70 percent of the ASP-I sites and 50 percent of the ASP-II sites will be located within the U.S.

Derived from the venom of the Malayan pit viper, Viprinex is a thrombin-like enzyme that is highly specific to fibrinogen. When administered systemically, the drug, a defibrinogenating agent, has been shown to rapidly deplete plasma fibrinogen. The effects of defibrinogenation are anticoagulation, improved blood viscosity and an indirect fibrinolytic or clot-lysing action. Combined, these properties have the potential to be uniquely effective at lysing blood clots and then maintaining reperfusion to the affected areas of the brain.