Fifth DSMB Meeting Supports Neurobiological Technologies' Continuation Of Phase 3 Stroke Trials With Viprinex(TM) (ancrod)

Main Category: Stroke / Neuroprotection
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 18 Apr 2008 - 0:00 PDT

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Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII), announced that after a scheduled review, an independent data safety monitoring board (DSMB) has recommended continuation of the company's two Phase 3 clinical trials to determine whether a brief intravenous infusion of Viprinex(TM) (ancrod) started within 6 hours of stroke onset improves functional outcome at 3 months. This is the fifth DSMB meeting for the Ancrod Stroke Program (ASP). The two trials are:

-- ASP-I, the Study of Acute Viprinex for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute, Ischemic Stroke.

-- ASP-II- A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod in Subjects Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke.

About Neurobiological Technologies:

Neurobiological Technologies, Inc, (Nasdaq: NTII) is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate in phase 3 clinical testing is Viprinex(TM) (ancrod), a novel agent with multiple mechanisms that is specifically designed to expand the treatment window for treating acute ischemic stroke, one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. Its pipeline includes other drug candidates in early-stage development, including a first-of-its-kind drug for the treatment of Alzheimer's disease.

Forward Looking Statement:

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including uncertainties regarding the successful completion of clinical trials for Viprinex, as well as other risks detailed from time to time in our Annual Report of Form 10-K and other filings with the Securities and Exchange Commission. There can be no assurance that Viprinex will prove to be safe or effective in the ongoing Phase 3 trials or that it will receive regulatory approval for commercialization. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. We undertake no obligation to update these forward-looking statements.

Neurobiological Technologies, Inc.
http://www.ntii.com