Neurobiological Technologies Announces Viprinex(TM) Does Not Pass Interim Futility Analysis Further Enrollment in Viprinex Clinical Studies to be Terminated
EMERYVILLE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII) today announced that an independent Data Safety Monitoring Board (DSMB) has determined that the current clinical trials of Viprinex(TM) for the treatment of acute ischemic stroke are unlikely to show benefit. As a result, the company has terminated further enrollment inthe trials. NTI will obtain and analyze the data before evaluating the potential for any future development of Viprinex. The interim analysisconducted by the DSMB evaluated stroke patients' outcome 90 days following an acute ischemic stroke, comparing treatment with Viprinex to treatment with placebo. The DSMB determined that there was no clinically meaningful difference in outcome between the two treatment groups as measured on the modified Rankin scale of disability, the primary endpoint of the study.
"We are deeply disappointed that Viprinex did not improve overall patientoutcomes in our clinical study," said Paul E. Freiman, president and chiefexecutive officer. "This news is a significant set-back for our clinicalprogram. Once we obtain the data and we have analyzed the results from thisstudy, which we expect to occur in early 2009, we will determine whether wewill pursue any further development of Viprinex. In the meantime, we areimplementing plans we have developed to reduce our expenses, which will likelyresult in a significant reduction in our overall headcount if we determinethat future development of Viprinex is not warranted."
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc., (Nasdaq: NTII) is a biopharmaceuticalcompany focused on developing novel, first-in-class agents for central nervoussystem conditions and other serious unmet medical needs. The Company's mostadvanced product candidate, Viprinex(TM) (ancrod), has been studied in Phase 3clinical trials for evaluation as a new drug to treat acute ischemic stroke;the future development of Viprinex is under consideration. NTI also has early-stage development programs for Alzheimer's and Huntington's diseases andrights to receive payments on an approved drug for Alzheimer's disease and aninvestigational drug in Phase 3 trials for brain swelling.
SOURCE Neurobiological Technologies, Inc.