Neurobiological Technologies has announced the enrollment of the first patient into the first of two Phase III studies of Viprinex (ancrod) injection to be run concurrently in patients with acute ischemic stroke.
The primary endpoint of the first clinical trial is the proportion of patients alive and independent in day-to-day function at 90 days as measured with the Barthel Index, an evaluation tool used to assess patient function in various basic activities of daily living. The Barthel Index explicitly explores ten different areas such as feeding, grooming, mobility, and bathing to determine independence in daily function.
Both studies in the clinical program are double-blind, randomized, placebo-controlled trials of patients who will receive a brief intravenous infusion of Viprinex or placebo within six 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 worldwide.