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 in
the trials. NTI will obtain and analyze the data before evaluating the
potential for any future development of Viprinex. The interim analysis
conducted 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 patient
outcomes in our clinical study," said Paul E. Freiman, president and chief
executive officer. "This news is a significant set-back for our clinical
program. Once we obtain the data and we have analyzed the results from this
study, which we expect to occur in early 2009, we will determine whether we
will pursue any further development of Viprinex. In the meantime, we are
implementing plans we have developed to reduce our expenses, which will likely
result in a significant reduction in our overall headcount if we determine
that future development of Viprinex is not warranted."
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), has been studied in Phase 3
clinical 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 and
rights to receive payments on an approved drug for Alzheimer's disease and an
investigational drug in Phase 3 trials for brain swelling.
SOURCE Neurobiological Technologies, Inc.