EMERYVILLE, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. today announced enrollment of the first patient into the first of two Phase III studies of Viprinex(TM) (Ancrod) Injection to be run concurrently in patients with acute, ischemic stroke.
Dr. David E. Levy Vice President of Clinical Development of NTI said, “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 Barthel Index explicitly explores ten different areas such as feeding, grooming, mobility, and bathing to determine independence in daily function. The continuous Barthel Index is a secondary endpoint. Other secondary endpoints include the modified Rankin Scale, another measure of daily function that also incorporates patient symptoms and lesion volume as determined on a 5-day MRI. 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. Versions of Rankin and Barthel will be secondary endpoints.
Commenting on the difference between this current and the prior clinical program of Viprinex conducted by Knoll AG, Dr. Levy said, “The present program differs from three prior studies of Viprinex in that it will utilize an intravenous infusion lasting no more than 3 hours in contrast to 5 to 7 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.”
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 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 worldwide.
Paul E. Freiman, President and CEO stated, “It is our intent to develop and commercialize Viprinex in the United States. We see this product as the foundation of our future growth and presence in the marketplace.”
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 as additional merger consideration.
About Neurobiological Technologies, Inc.
NTI is a drug development company focused on the clinical evaluation and regulatory approval of neuroscience drugs. The company’s strategy is to in-license and develop early- and later-stage drug candidates that target major medical needs and which can be rapidly commercialized. NTI’s experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy and seeks partnerships with pharmaceutical and biotechnology companies to complete development and marketing of its product candidates.
Cautionary Note Regarding Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, and other risks detailed from time to time in our Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. We disclaim, however, any intent or obligation to update these forward-looking statements.
Neurobiological Technologies, Inc.
CONTACT: Paul E. Freiman, President & CEO, +1-510-595-6000, or David E.Levy, Vice President Clinical Development, +1-201-941-5000, both ofNeurobiological Technologies, Inc.; or Cheryl Schneider, VP - InvestorRelations, Porter, Le Vay & Rose, Inc., +1-212-564-4700, forNeurobiological Technologies, Inc.
Web site: http://www.ntii.com/