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.
The new studies differ from three prior studies of Viprinex in that it will utilize an intravenous infusion lasting no more than three hours in contrast to five to seven days of treatment in previous trials.
“We expect that this shorter but more intense treatment regimen will increase the proportion of patients benefiting from Viprinex and reduce the risk of symptomatic intracranial hemorrhage,” commented Dr David Levy, vice president of clinical development at Neurobiological Technologies (NTI).
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, a widely accepted evaluation tool used in the stroke medical community to assess patient function in various basic activities of daily living.
The second phase III study, scheduled to begin by the end of calendar year 2005, will evaluate independent day-to-day function using the dichotomized modified Rankin Scale as the primary endpoint.
NTI acquired the exclusive worldwide rights to Viprinex in July 2004 from Empire Pharmaceuticals in a merger transaction. Under the terms of the merger agreement and as a result of the commencement of these new phase III clinical trials for Viprinex, NTI will pay the former stockholders of Empire $2 million and issue 2,375,176 shares of common stock.