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Neurobiological Technologies Reaches Patient Enrollment Target For Interim Analysis of Viprinex(TM) Phase 3 Stroke Trials
Date:8/12/2008

EMERYVILLE, Calif., Aug. 12 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) today announced that enrollment into its two Phase 3 pivotal studies evaluating Viprinex(TM) (ancrod) for the treatment of acute ischemic stroke has reached the level of patients necessary to conduct a planned interim analysis across the two studies. NTI is currently studying whether Viprinex is safe and effective for treating acute ischemic stroke when given within six hours of stroke onset.

"We are very pleased to have reached the enrollment criteria to conduct the planned interim analysis," stated Paul E. Freiman, president and chief executive officer of NTI. "Our independent Data Safety Monitoring Board (DSMB) will meet to review the efficacy data on an unblinded basis for the first time. In addition, the DSMB will evaluate the safety of Viprinex, as they've been doing since the start of the studies."

Results of the interim analysis are expected in January 2009. The interim analysis will be based on the first 500 treated patients in the current trials who have completed their 90 day assessment. If the treatment effect observed for the ancrod patients is not better than that observed for the placebo patients, then the trials will be halted for futility, indicating that they are unlikely to demonstrate the benefit required for approval. If the trials are allowed to continue, NTI will not have access to any unblinded patient data until the trials are completed. The primary endpoint of the trials is the modified Rankin Score, a measure of disability.

"We believe that data from 500 patients is sufficient for the DSMB to conduct a thorough assessment of futility, and have accordingly moved up the interim anal
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SOURCE Neurobiological Technologies, Inc.
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