EMERYVILLE, Calif., March 22 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. today announced the initiation of its second Phase III study of Viprinex(TM) (Ancrod) in patients with acute ischemic stroke. The overall clinical development program for both trials will enroll 1,300 patients, divided equally between the two trials. The program will be global in nature recruiting patients in the United States, Europe, the Pacific Rim, and South Africa.
This second Phase III trial, known as Ancrod Stroke Program-II (ASP-II), will evaluate the dichotomized modified Rankin Scale as the primary endpoint. The dichotomized modified Rankin Scale measures independent day-to-day function of patients 90 days post stroke. Secondary endpoints include other analyses of the Rankin and the Barthel Index. Both Rankin and Barthel are standardized measures that have been used by the stroke community for many years and are believed to be widely acceptable to both physicians and regulators.
ASP-II is a randomized, double-blind, placebo-controlled trial of patients who will receive a brief intravenous infusion of Viprinex or placebo within 6 hours of the onset of stroke. The dosing of Viprinex in both ASP-I and ASP-II will be approximately one-tenth of the dosing used in prior Viprinex clinical programs conducted by Knoll AG. This is based on a single one-day infusion, as opposed to either five or seven days used in previous clinical trials.
Paul E. Freiman, President and CEO of NTI, said, “We continue to move forward with our clinical development program and the initiation of the second trial is an important step along the way. We believe that Viprinex is a unique reperfusion agent embodying three distinct mechanisms of action. Clinical data suggest that Viprinex is a powerful defibrinogenating agent causing enhanced blood flow, a fibrinolytic agent, as well as an anticoagulant helping to limit stroke extension. There is no product that has this triple mechanism of action. Based on our analysis of the data from the Knoll trials, we believe that the single dosing will reduce the risk of intracranial hemorrhaging and support the previous data showing evidence of these mechanisms of action.”
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/
