Analysis Of Earlier European Stroke Trial Supports Treatment Regimen For Viprinex(TM) In Current International Phase 3 Clinical Trials

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry;  Conferences
Article Date: 26 Sep 2008 - 0:00 PDT

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Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) announced that previously found excess symptomatic intracranial hemorrhage in an earlier European trial of ancrod (now Viprinex(TM)) for the treatment of acute ischemic stroke may be minimized with avoidance of prolonged low levels of fibrinogen and use of common blood pressure entry criteria.

The data, presented at the 6th World Stroke Conference in Vienna, Austria, are from a retrospective analysis led by NTI scientists of two previous Phase 3 clinical trials, known as STAT and ESTAT, which involved more than 1700 patients and were conducted before NTI acquired the rights to ancrod. The STAT trial in the United States showed ancrod-treated patients had a better outcome than placebo-treated patients, while the European ESTAT trial showed an ancrod treatment outcome similar to placebo, but a higher rate of symptomatic intracranial hemorrhages. When the drug safety information from the trials were compared, it was noted that patients treated with ancrod in ESTAT who had symptomatic intracranial hemorrhages were more likely to have had prolonged low fibrinogen blood levels, to have received higher doses of ancrod and to have had higher blood pressures at trial entry.

"The conclusions of this analysis provided NTI with the information needed to revise the dosing regimen to avoid prolonged low fibrinogen levels and launch new Phase 3 clinical trials using common blood pressure patient-entry criteria," says Gregory del Zoppo, M.D. of the University of Washington, chairman of the current ancrod clinical trials' steering committee, and a coauthor of the retrospective analysis.

"Earlier Viprinex trials used a dosing regimen that infused the drug over five to seven days, which kept blood fibrinogen levels low for too long," said David Levy, Vice President, Clinical Development of NTI, who led the analysis. "We changed the treatment paradigm to a three-hour infusion which has been designed to reduce fibrinogen levels quickly, while also avoiding prolonged low fibrinogen levels as seen in the ESTAT data."

Using the revised dosing regimen, NTI is currently conducting two Phase 3 clinical trials of Viprinex to investigate whether ancrod can safely and effectively reduce disability following an acute ischemic stroke. The trials are being conducted in 14 countries throughout the world, and to date have enrolled over 500 patients. NTI believes that Viprinex can be administered up to six hours after the onset of stroke symptoms, significantly expanding the number people who can be treated compared to the single currently approved drug for the treatment of stroke in the U.S.

Viprinex (ancrod) is a novel Fibrinogen Reducing Agent (FRA), the active ingredient of which is an enzyme that reduces blood levels of fibrinogen, the primary protein involved in blood clotting. It is derived from Malayan pit viper venom and is highly specific for fibrinogen.

Previous research suggests that Viprinex may work in three ways to improve blood flow to areas of the brain affected by the stroke by:

-- Interfering with fibrinogen's ability to participate in blood clot formation, which should limit clot growth and reduce odds of reocclusion due to new clots.

-- Reducing blood viscosity (resistance to flow), which should improve blood flow to areas of the brain affected by the stroke.

-- Indirectly activating the natural blood clot dissolving mechanism, which should restore blood flow further to areas of the brain affected by the stroke.

About Neurobiological Technologies, Inc.

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, Viprinex(TM) (ancrod), is in Phase 3 clinical testing as a novel investigational drug for the treatment of acute ischemic stroke. Viprinex has multiple mechanisms of action and is specifically designed to extend the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. NTI also has early-stage development programs for Alzheimer's and Huntington's diseases and rights to receive payments on an approved drug for Alzheimer's disease and an investigational drug in Phase 3 trials for brain swelling.

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 uncertainties regarding the development of Viprinex for acute ischemic stroke, delays or other problems with our clinical trials, the outcome of the interim analysis, the time and costs for obtaining approval for Viprinex, and levels of future expenditures and capital resources needed to fund operations, as well as other risks detailed from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K, as updated periodically in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release and we undertake no obligation to update these forward-looking statements.

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