Viprinex™ (Ancrod) - Investigational Drug Being Pursued For The Treatment Of Ischaemic Stroke

Main Category: Stroke / Neuroprotection
Article Date: 31 May 2007 - 12:00 PDT

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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™ (ancrod), for the treatment of acute ischaemic stroke at the 16th annual European Stroke Congress in Glasgow, Scotland in the United Kingdom. Viprinex is a definbrinogenating agent derived from the venom of the Malayan pit viper.

"The ancrod data presented this week in Glasgow draws positive conclusions that support a new dosing regimen for ancrod and revised inclusion/exclusion criteria for the current clinical trials," said David Sherman , MD, University of Texas Health Science Center at San Antonio, USA. "The reanalysis enables us to see that ancrod may be safe and effective when administered to patients within six hours of stroke onset. With so few treatments currently available to stroke patients, we look forward to the results of the international phase 3 trials. We hope the phase 3 results provide evidence of definitive safety and efficacy of ancrod in ischaemic stroke in the six-hour time window."

Viprinex™-related sessions at the 2007 European Stroke Congress are:

-- Poster Session II P 29: Ancrod in a Six Hour Time Window? Evidence For and Against Efficacy by D.G.Sherman University of Texas Health Science Center at San Antonio, USA Thursday, 31 May 2007 13:00 to 14:00 GMT
-- Ongoing Trials Abstract #19: Ancrod Stroke Program (ASP): Two Phase 3 International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trials of Ancrod in Acute Ischaemic Stroke by David E. Levy, MD (Neurobiological Technologies)

NTI is moving forward with two international, randomized, double-blind, placebo-controlled phase 3 trials for Viprinex™ as part of the Ancrod Stroke Program (ASP). These trials, known as ASP-I and ASP-II, will evaluate whether a brief (2 or 3 hour) infusion of ancrod begun up to six hours after onset of stroke can reduce stroke related disability. ASP-I and II are currently enrolling and each trial is planned to enroll 650 patients. Patient accrual began in November 2005. The trials are being conducted in the U.S., Europe, South Africa, Australia, and New Zealand. Additional countries will be entering the program. The company expects that the trials will be conducted at up to 130 sites worldwide and that approximately 70% of the ASP-I sites and approximately 50% of the ASP-II sites will be located within the U.S. Patients who qualify for enrollment into the clinical trials will receive a two or three-hour intravenous infusion of ancrod or placebo within six hours of stroke onset. If treated within three hours of stroke onset, subjects must have been determined unsuitable for treatment with tPA.

"We have data showing that fibrinogen plays a significant role in influencing stroke outcome. Ancrod directly targets fibrinogen and has the potential to treat strokes by rapidly lowering fibrinogen levels," said David E. Levy, MD, Vice President of Clinical Development for NTI. "We are aggressively recruiting patients worldwide for the ASP-I and ASP-II studies. We hope by garnering a large patient base for the study we can generate the robust data needed to confirm our new dosing strategy and six hour treatment window for acute ischaemic stroke."

About Viprinex™ (ancrod)

Ancrod, a novel reperfusion agent being investigated for acute ischaemic stroke (AIS), is a defibrinogenating enzyme derived from the venom of the Malayan pit viper, a potent, natural anticoagulant. 'Reperfusion' means that it helps restore blood flow. Ancrod does this by acting directly on fibrinogen, a protein involved in blood clotting. Ancrod cleaves fibrinogen to prevent clot formation and reduces blood viscosity, which may lead to improved blood flow within the affected area. Ancrod also indirectly causes the clot to break up. In contrast, other approved drugs or drugs in clinical development for AIS do not directly target fibrinogen. Ancrod has multiple mechanisms of action to help rapidly achieve three biological effects: blood viscosity reduction, thrombus modification, and alteration of hemostasis. The three effects of ancrod provide a potent yet potentially safe means of limiting brain damage with stroke.

About Neurobiological Technologies, Inc.

Neurobiological Technologies, Inc. (NTI) (NASDAQ: NTII) 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 www.ntii.com.

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