NTII Neurobiological Technologies (MM)

Investigational Drug Being Pursued for the Treatment of Ischemic Stroke SAN FRANCISCO, Feb. 8 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI) (NASDAQ:NTII) announced today the presentation of new analysis of data from prior clinical trials of ancrod and updates on the clinical development of their investigational drug, Viprinex(TM) (ancrod), for the treatment of acute ischemic stroke at the American Stroke Associations' International Stroke Conference 2007. Viprinex is a definbrinogenating agent derived from the venom of the Malayan pit viper. "The ancrod data presented this week support the role of fibrinogen in influencing stroke outcome and the potential role for ancrod in treating strokes by lowering fibrinogen levels," said David E. Levy, MD, Vice President of Clinical Development for NTI. "Analysis of data from prior clinical trials also appears to suggest that the dosing level of the current Phase 3 trials may provide definitive safety and efficacy of ancrod in ischemic stroke." Viprinex(TM)-related sessions at the 2007 International Stroke Conference are: * Oral Abstract 77: Admission Fibrinogen Level and Outcome from Acute, Ischemic Stroke: Experience from Studies with Ancrod by David E. Levy, MD (Neurobiological Technologies) Thursday, February 08, 2007 10:22 AM to 10:34 AM * Clinical Trials Poster P39: ASP: The Ancrod Stroke Program by David E. Levy, MD (Neurobiological Technologies) Wednesday, February 07, 2007 5:30 PM to 7:30 PM * Poster P91: Ancrod for Acute Ischemic Stroke: A Systematic Review and Meta-analysis by Bart M. Demaerschalk, MD and Bentley Bobrow, MD (Mayo Clinic, Scottsdale/Phoenix, Ariz) Thursday, February 08, 2007 5:30 PM to 7:30 PM NTI is moving forward with two international, placebo-controlled Phase 3 trials for Viprinex(TM) as part of the Ancrod Stroke Program (ASP). These trials, known as ASP-I and ASP-II, will evaluate whether a brief infusion of Viprinex begun up to six hours after onset of stroke symptoms can minimize neurological damage, while maximizing functional outcomes in stroke patients. The primary endpoint is death or disability at 90 days. Each of these trials will enroll 650 patients. Patient accrual began in November 2005 and is expected to continue into 2008. In the ASP studies, patients will receive a single two to three hour infusion of Viprinex, leading to a significantly lower overall dose than that used in previous Phase 3 studies, which employed dosing over five to seven days. The aim is to lower the fibrinogen rapidly, while avoiding prolonged low fibrinogen levels. It is hoped that this modified dosing schedule will improve both the potential safety and efficacy of the drug. "We conducted a systematic review and meta-analysis of six trials of defibrinogenating agents, like ancrod, involving more than four thousand patients to assess the potential efficacy and safety of this investigational drug for acute ischemic stroke," said Bart M. Demaerschalk, MD, of Mayo Clinic. "It appears that ancrod may be promising for the treatment of acute ischemic stroke, but we need more data, particularly from the ASP-I and ASP-II studies. The dosing used in the ASP trials is different from the earlier trials and the results of using this new dosing schedule will be interesting to follow." About Viprinex(TM) (ancrod) Viprinex(TM) (ancrod), NTI's investigational drug for the treatment of acute ischemic stroke, is a defibrinogenating enzyme derived from the venom of the Malayan pit viper. Viprinex has a two-fold mechanism of action to address three dynamics in acute ischemic stroke: anti-coagulation (prevents clots from forming), fibrinolysis (dissolves existing clots) and improved blood viscosity (thins out the blood and improves blood flow to the brain). About Neurobiological Technologies, Inc. Neurobiological Technologies, Inc. (NTI) is a biotechnology company engaged in the business of acquiring and developing central nervous system related drug candidates. The Company is focused on therapies for neurological conditions that occur in connection with ischemic stroke, brain cancer, Alzheimer's disease and dementia. The Company's strategy is to in-license and develop later-stage drug candidates that target major medical needs and that can be rapidly commercialized. NTI's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy. For further information, please visit NTI's website at http://www.ntii.com/. 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 need for additional capital, risks related to clinical trials and the 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 Annual Report of Form 10-K and other filings with the Securities and Exchange Commission. 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. DATASOURCE: Neurobiological Technologies, Inc. CONTACT: Russell LaMontagne, +1-917-744-7957, or , for Neurobiological Technologies, Inc. Web site: http://www.ntii.com/

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