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Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data
Date:10/13/2008

- Company Plans to Announce Interim Results in January 2009 and Final Trial

Data in mid-2009 -

EMERYVILLE, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) today announced that following a meeting with the U.S. Food and Drug Administration to discuss the Viprinex(TM) (ancrod) Phase 3 clinical program for acute ischemic stroke, the company plans to consolidate and analyze data from its two concurrently running double-blind clinical trials into a single Phase 3 pivotal trial. This new plan will accelerate the timing of the trial's efficacy and safety data to mid-2009. The previously announced interim analysis based on the first 500 treated patients is estimated to be completed by January 2009.

When a total of 650 treated patients has been accrued in the two trials, which is expected to occur in the first quarter of 2009, enrollment will be closed and the data will be merged into one blinded dataset. Since the two concurrent Phase 3 studies employ the same protocol and patient entry criteria, the validity of the single merged study remains the same as initially designed for the two individual studies.

"This is game-changing for us, our shareholders and patients," said Paul E. Freiman, president and chief executive officer. "This new plan allows us to obtain data much sooner to guide future clinical and business decisions. If results are positive, we will be able to move the program forward with much more information and a higher level of confidence. If the study fails, we will be able to curtail spending on the program at a much earlier point in time, saving precious financial resources."

The interim analysis will be conducted by an ind
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SOURCE Neurobiological Technologies, Inc.
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