Neurobiological Technologies Announces Viprinex(TM) Does Not Pass Interim Futility Analysis
17 Décembre 2008 - 1:00PM
PR Newswire (US)
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
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.
DATASOURCE: Neurobiological Technologies, Inc. CONTACT: Matthew M.
Loar, CFO of Neurobiological Technologies, Inc., +1-510-595-6000
Web site: http://www.ntii.com/
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