EMERYVILLE, Calif., May 4 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. , today announced the initiation of the first site outside the U.S. for its global Phase III acute ischemic stroke trials for Viprinex(TM) (Ancrod). The Ancrod Stroke Program I (ASP-I) and Program II (ASP-II) 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 and that 30% of the ASP-I trials and 50% of the ASP II trials will be conducted in sites outside the U.S.
Paul E. Freiman, President and CEO of NTI said, "We have carefully chosen sites outside the U.S. where the standard of care is at the highest level and where data has proven to be reliable. In previous trials of Viprinex run by Knoll Pharmaceuticals, recruitment rates at individual sites overseas were higher than those domestically. Stroke is a terrible occurrence and knows no national borders. With successful results, it is our intent to seek to commercialize Viprinex on a worldwide basis."
About Neurobiological Technologies, Inc.
NTI (www.ntii.com) 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 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.
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 of Neurobiological Technologies,Inc., +1-510-595-6000; or Cheryl Schneider, VP - Investor Relations ofPorter, Le Vay & Rose, Inc., +1-212-564-4700, for NeurobiologicalTechnologies, Inc.
Web site: http://www.ntii.com//
