�Neurobiological
Technologies, Inc. (NTI(R)) (Nasdaq: NTII) announced that enrollment
into its deuce Phase 3 pivotal studies evaluating Viprinex(TM) (ancrod) for
the discussion of acute ischemic stroke has reached the layer of patients
necessary to conduct a planned interim analysis crosswise the two studies. NTI
is presently studying whether Viprinex is safe and effective for treating
acute ischemic stroke when given within six-spot hours of stroke onset.
"We ar very pleased to experience reached the enrollment criteria to lead
the aforethought interim analysis," stated Paul E. Freiman, president and chief
executive officer of NTI. "Our independent Data Safety Monitoring Board
(DSMB) will meet to limited review the efficaciousness data on an unblinded basis for the
first time. In addition, the DSMB volition evaluate the safety of Viprinex, as
they've been doing since the startle of the studies."
Results of the interim analysis are expected in January 2009. The
interim analysis will be based on the first 500 tempered patients in the
stream trials wHO have completed their 90 day judgment. If the treatment
effect observed for the ancrod patients is not bettor than that observed
for the placebo patients, then the trials will be halted for futility,
indicating that they are unlikely to attest the benefit required for
approval. If the trials are allowed to continue, NTI testament not experience access
to any unblinded patient information until the trials ar completed. The primary
termination of the trials is the modified Rankin Score, a quantity of
disablement.
"We believe that data from five hundred patients is sufficient for the DSMB to
comport a thorough assessment of futility, and have consequently moved up
the meantime analysis from earlier plans to conduct it at 650 patients,"
stated Warren W. Wasiewski, M.D., vice president and chief medical officer.
"This is a significant milestone for the program and we are all look
forward to learning the outcome of this review."
About Ischemic Stroke Ischemic accident is caused by obstruction of a blood vessel in the brain
referable to a clot. The lack of blood flow, or ischemia, leads to cell death.
According to the American Heart Association, 87% of the 700,000 yearly
strokes in the United States are ischemic. Stroke is the third preeminent
cause of death in the United States, behind heart disease and cancer, and
the leading cause of handicap. The only FDA-approved do drugs for the
treatment of acute ischemic stroke is Activase(R) (alteplase), which
presently must be given within three hours of stroke onset.
About Neurobiological Technologies, Inc. Neurobiological Technologies, Inc., (Nasdaq: NTII) is a
biopharmaceutical company focussed on developing novel, first-in-class
agents for central nervous system atmospheric condition and former serious unmet
medical necessarily. The Company's most advanced product campaigner, Viprinex(TM)
(ancrod), is in Phase 3 clinical testing as a novel investigational drug
for the treatment of acute ischemic cerebrovascular accident. Viprinex has multiple
mechanisms of action and is specifically designed to double the time period
that patients can buoy be treated after the onset of a stroke. Acute ischaemic
stroke is one of the about prevalent, debilitating and pricy diseases in
the humans for which there are few satisfactory treatment options. NTI too
has early-stage development programs for Alzheimer's and Huntington's
diseases and rights to receive payments on an approved dose for Alzheimer's
disease and an investigational drug in Phase 3 trials for brain swelling.
Forward Looking Statements Except for the historical information contained herein, the matters
discussed in this press release are modern statements that involve
risks and uncertainties, including uncertainties regarding the outcome of
the interim analysis, obtaining approval for Viprinex, levels of future
expenditures and capital resources needed to fund trading operations, as well as
other risks elaborated from sentence 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 whitethorn 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.
Neurobiological Technologies, Inc.
http://www.ntii.com
More info
