Analysis of Earlier European Stroke Trial Supports Treatment Regimen for Viprinex(TM) in Current International Phase 3 Clinical
September 25 2008 - 6:00AM
PR Newswire (US)
EMERYVILLE, Calif., Sept. 25 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NTI(R)) (NASDAQ:NTII) today
announced that previously found excess symptomatic intracranial
hemorrhage in an earlier European trial of ancrod (now
Viprinex(TM)) for the treatment of acute ischemic stroke may be
minimized with avoidance of prolonged low levels of fibrinogen and
use of common blood pressure entry criteria. The data, presented
today at the 6th World Stroke Conference in Vienna, Austria, are
from a retrospective analysis led by NTI scientists of two previous
Phase 3 clinical trials, known as STAT and ESTAT, which involved
more than 1700 patients and were conducted before NTI acquired the
rights to ancrod. The STAT trial in the United States showed
ancrod-treated patients had a better outcome than placebo-treated
patients, while the European ESTAT trial showed an ancrod treatment
outcome similar to placebo, but a higher rate of symptomatic
intracranial hemorrhages. When the drug safety information from the
trials were compared, it was noted that patients treated with
ancrod in ESTAT who had symptomatic intracranial hemorrhages were
more likely to have had prolonged low fibrinogen blood levels, to
have received higher doses of ancrod and to have had higher blood
pressures at trial entry. "The conclusions of this analysis
provided NTI with the information needed to revise the dosing
regimen to avoid prolonged low fibrinogen levels and launch new
Phase 3 clinical trials using common blood pressure patient-entry
criteria," says Gregory del Zoppo, M.D. of the University of
Washington, chairman of the current ancrod clinical trials'
steering committee, and a coauthor of the retrospective analysis.
"Earlier Viprinex trials used a dosing regimen that infused the
drug over five to seven days, which kept blood fibrinogen levels
low for too long," said David Levy, Vice President, Clinical
Development of NTI, who led the analysis. "We changed the treatment
paradigm to a three-hour infusion which has been designed to reduce
fibrinogen levels quickly, while also avoiding prolonged low
fibrinogen levels as seen in the ESTAT data." Using the revised
dosing regimen, NTI is currently conducting two Phase 3 clinical
trials of Viprinex to investigate whether ancrod can safely and
effectively reduce disability following an acute ischemic stroke.
The trials are being conducted in 14 countries throughout the
world, and to date have enrolled over 500 patients. NTI believes
that Viprinex can be administered up to six hours after the onset
of stroke symptoms, significantly expanding the number people who
can be treated compared to the single currently approved drug for
the treatment of stroke in the U.S. Viprinex (ancrod) is a novel
Fibrinogen Reducing Agent (FRA), the active ingredient of which is
an enzyme that reduces blood levels of fibrinogen, the primary
protein involved in blood clotting. It is derived from Malayan pit
viper venom and is highly specific for fibrinogen. Previous
research suggests that Viprinex may work in three ways to improve
blood flow to areas of the brain affected by the stroke by: --
Interfering with fibrinogen's ability to participate in blood clot
formation, which should limit clot growth and reduce odds of
reocclusion due to new clots. -- Reducing blood viscosity
(resistance to flow), which should improve blood flow to areas of
the brain affected by the stroke. -- Indirectly activating the
natural blood clot dissolving mechanism, which should restore blood
flow further to areas of the brain affected by the stroke. 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. Acute ischemic stroke is one of the most prevalent,
debilitating and costly diseases in the world for which there are
few acceptable treatment options. 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. 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, 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: Matthew M. Loar, CFO of
Neurobiological Technologies, Inc., +1-510-595-6000 Web site:
http://www.ntii.com/
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