EMERYVILLE, Calif., Feb. 16 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) today announced it will be briefing attendees of the International Stroke Conference informally on its Ancrod Stroke Program for the treatment of acute ischemic stroke. The conference runs through Saturday, February 18, 2006.
Neurobiological Technologies is currently engaged in a Phase III, doubleblind, randomized, placebo-controlled study to determine whether a single, brief IV infusion of Viprinex(TM) (ancrod) begun within 6 hours of stroke onset confers statistically significant benefit in reducing the incidence of death or disability at 90 days. Six hundred fifty subjects are to be enrolled at 65 sites world-wide (North America, Europe, Australasia, and South Africa).
Dr. David E. Levy, Vice President of Clinical Development at Neurobiological Technologies, 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.”
He added, “There have been three prior studies of ancrod of nearly 2000 stroke patients. These analyses suggest that a dosing strategy consisting of a brief, relatively rapid ancrod infusion with no maintenance dosing will be both effective and safe. This is the first of two Phase III studies being conducted on ancrod for acute ischemic stroke. Enrollment began in November 2005 and is expected to continue through 2007.”
Viprinex (ancrod) is an enzyme derived from the Malayan pit viper that cleaves fibrinogen. This fibrinogenase activity results in anticoagulation, improved blood viscosity, and indirect fibrinolysis.
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. We anticipate that we will continue to acquire and develop late-stage neurologic drug candidates and will develop the resources to market these drugs in selected world regions. Our goal is to develop and market drug candidates in the United States, Europe and Asia and we may seek partnerships with pharmaceutical and biotechnology companies to assist us.
NOTE: 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, the risks associated with the cost 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 Dr. DavidE. Levy, Vice President of Clinical Development, +1-201-941-5000, both ofNeurobiological Technologies, Inc.; or investors, Cheryl Schneider, VP -Investor Relations of Porter, Le Vay & Rose, Inc., +1-212-564-4700, forNeurobiological Technologies, Inc.
Web site: http://www.ntii.com/
