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FDA Grants Investigational Drug, Ancrod, Fast-Track Status for Use in Patients Suffering From Ischemic Stroke

RICHMOND, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NASDAQ:NTII) , a biotechnology company engaged in the business of acquiring and developing central nervous system related drug candidates, today announced that the U.S. Food and Drug Administration has granted the investigational drug, Viprinex(TM) (ancrod), fast-track status for its intended use in patients suffering from ischemic stroke. The fast-track designation provides for expedited regulatory review for new drug candidates demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Viprinex (ancrod) is under development for decreasing disability in patients with acute non-hemorrhagic stroke, treated within six hours of symptoms.

Paul Freiman, president and CEO of NTI, said, "In my forty-plus years of experience in this industry, it is often one product that transforms a company to the next level. I believe that Viprinex (ancrod) has this potential for NTI. There is a large unmet need in the treatment of ischemic stroke and if we prove in the clinic that Viprinex (ancrod) indeed has a positive outcome, we can become a very different company."

Viprinex (ancrod) was previously studied in approximately 2,000 patients in various clinical studies in the U.S. and Europe. Currently, the only available therapy for ischemic stroke must be administered within the initial three hours, significantly limiting the number of patients that may be treated.

It is estimated that less than five percent of stroke patients are suitable for current therapies and less than three percent actually receive treatment. The estimated direct and indirect costs of stroke in the U.S. in 2004 are thought to be $53.6 billion.

Source: Neurobiological Technologies, Inc.

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