Neurobiological Technologies chooses sites for phase 3 trial

By Elaine Rigoli

Tampa, Fla., Aug. 24 - Neurobiological Technologies, Inc. said it has completed its targeted U.S. site selection with 50 locations chosen for its first global phase 3 trial for Viprinex (ancrod injection) in acute ischemic stroke.

The ancrod stroke program (ASP) includes two double-blind, randomized, placebo-controlled clinical trials, ASP-I and ASP-II. Patients who qualify for enrollment into the clinical trials will receive a three-hour intravenous infusion of Viprinex or a placebo within six hours of stroke onset. Each trial is planned to enroll 650 patients.

The company said it expects that the trials will be conducted at up to 130 sites worldwide and that 70% of the ASP-I sites and 50% of the ASP-II sites will be located within the United States.

"Thus far we have gained approval and acquired sites in several countries, including the Netherlands, the Czech Republic, Russia, Australia, New Zealand and South Africa, making this trial truly global in nature. With the completion of U.S. site selection and our progress selecting sites outside of the U.S., we expect the pace of patient enrollment to pick up and to move close to our targeted patient enrollment levels," president and chief executive officer Paul Freiman said in a news release.

The company said its goal is to demonstrate that Viprinex has the potential to double the available treatment window following the onset of stroke symptoms, from three to six hours, thus expanding the potential number of patients who can be treated.

Neurobiological Technologies is a drug-development company based in Emeryville, Calif.

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