Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data
October 13 2008 - 7:30AM
PR Newswire (US)
- 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 independent Data Safety
Monitoring Board (DSMB) that will examine futility as well as
safety. This constitutes a "go, no-go" decision point for the
Viprinex clinical program. Passing the futility analysis would
indicate that the drug has met predetermined interim efficacy
criteria. Because full enrollment of the consolidated trial is
expected to be completed in the first quarter of 2009, NTI will not
perform a superiority analysis during the interim review, in order
to avoid taking a significant statistical penalty at the conclusion
of the trial. Performing the interim futility analysis as planned
does not carry any statistical penalty. "We are very excited that
after more than four years of hard work on our stroke program, we
are rapidly approaching these two major milestones," stated Warren
W. Wasiewski, M.D., vice president and chief medical officer.
"Along with the rest of the stroke-care community, which has few
treatment options at its disposal, I look forward with great
enthusiasm to both the DSMB recommendation and the results of
trial's final analysis." Conference Call Details NTI will hold a
conference call to discuss this development later today at 1:00
p.m. (ET), 10:00 a.m. PT. The dial-in number is 877-440-5803 in the
U.S. & Canada and 719-325-4942 elsewhere in the world. A
telephonic replay will be available from 1:00 p.m. ET on October
13, 2008 to midnight ET on October 20, 2008. The replay number is
888-203-1112 in the U.S and Canada and 719-457-0820 elsewhere. The
pass code is 9164451 for the conference calls. About the Current
Viprinex Stroke Trials The ongoing Phase 3 clinical studies are
designed to assess the efficacy and safety of Viprinex for the
treatment of acute ischemic stroke when initiated within six hours
of stroke onset. The studies are randomized, double-blind,
placebo-controlled trials. Approximately 145 clinical sites are
open to enroll patients into the trials in 14 countries. 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), is in Phase
3 clinical testing as a novel investigational drug for the
treatment of acute ischemic stroke. Viprinex has multiple
mechanisms of action and is specifically designed to extend the
time period that patients can be treated after the onset of a
stroke. NTI also has early-stage development programs for
Alzheimer's and Huntington's diseases, rights to receive payments
on an approved drug for Alzheimer's disease and an investigational
drug in Phase 3 trials for brain swelling. NOTE: Except for the
historical information contained herein, the matters discussed in
this press release are forward-looking statements that involve
risks and uncertainties, including uncertainties regarding the
development of Viprinex for acute ischemic stroke, delays or other
problems with our clinical trials, including the inability to
enroll patients at anticipated rates, the outcome of the interim
analysis, the time and costs for obtaining approval for Viprinex,
and levels of future expenditures and capital resources needed to
fund operations, as well as other risks detailed from time to time
in our filings with the Securities and Exchange Commission,
including our Annual Report on Form 10-K, as updated periodically
in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Actual results may differ materially from those projected. These
forward-looking statements represent our judgment as of the date of
the release and we undertake no obligation to update these
forward-looking statements. DATASOURCE: Neurobiological
Technologies, Inc. CONTACT: Media, Brian Reid of WeissComm
Partners, Inc., +1-703-402-3626, , for Neurobiological
Technologies, Inc.; or Investors, Matthew M. Loar of
Neurobiological Technologies, Inc., +1-510-595-6000 Web site:
http://www.ntii.com/
Copyright
Neurobiological (NASDAQ:NTII)
Historical Stock Chart
From Jun 2024 to Jul 2024
Neurobiological (NASDAQ:NTII)
Historical Stock Chart
From Jul 2023 to Jul 2024