NICE, France, May 14 NTII-Present-European
NICE, France, May 14 /PRNewswire-FirstCall/ -- Neurobiological
Technologies, Inc. (NTI(R)) (Nasdaq: NTII) reported for the first time at the
European Stroke Conference detailed analyses supporting the dosing regimen in
NTI's two ongoing Phase 3 studies of Viprinex(TM) (ancrod) for ischemic
stroke. The company also provided information as to why it believes these
studies are more likely to be successful in treating ischemic stroke than
previous Phase 3 clinical trials conducted by others using the same snake
venom-derived agent.
David E. Levy, M.D., Vice President, Clinical Development at NTI,
presented his retrospective analysis of data from the prior North American and
European Phase 3 stroke trials of Viprinex involving more than 1,700 patients.
Viprinex has been shown to rapidly reduce blood levels of fibrinogen, an
important agent involved in blood clotting and blood viscosity. Elevated
fibrinogen levels are a risk factor for stroke and may be associated with
greater stroke disability. Prior studies with Viprinex that target fibrinogen
have shown a benefit from this approach.
"The prior studies of Viprinex showed improved efficacy, but used a dosing
regimen that infused the drug over five to seven days, which kept fibrinogen
levels low for too long, compromising safety," said Dr. Levy, the key
presenter. "NTI has changed the treatment paradigm to a single, three-hour
intravenous dose designed to reduce fibrinogen levels quickly, while avoiding
the prolonged low fibrinogen levels that were tried previously. Stopping the
infusion after three hours permits fibrinogen to return to normal levels much
faster than when the drug is given over five to seven days."
Dosing in the successful North American Phase 3 trial was compared to
dosing in the unsuccessful European Phase 3 trial. The analyses showed that
European patients initially infused with Viprinex at the most rapid rate had
statistically significant efficacy with Viprinex versus placebo. The analysis
also showed that patients across both studies whose mean fibrinogen levels
were kept above a certain threshold over the entire five to seven day
treatment period had a rate of symptomatic intracranial hemorrhage that was
substantially lower than in those with lower mean fibrinogen levels over the
same five to seven day period. These data suggest that rapid initial lowering
of fibrinogen is associated with better efficacy, but for safety purposes
fibrinogen should be allowed to return back up to its higher level after
treatment.
"Viprinex, a novel Fibrinogen Reducing Agent, is an enzyme that reduces
levels of fibrinogen, the primary protein involved in blood clotting," said
Warren W. Wasiewski, M.D., Vice President and Chief Medical Officer of
Neurobiological Technologies, Inc. and a second author of the retrospective
analysis. "Reducing fibrinogen in the blood lowers blood viscosity, which may
improve blood flow. Additionally, as the fibrinogen is broken down, natural
mechanisms are activated to dissolve blood clots that have already formed.
Since Viprinex acts in the blood for a longer period of time than existing
therapies for treatment of stroke, the effect of Viprinex on brain blood flow
should be sustained longer. We believe that a single infusion of Viprinex
would be better than a prolonged infusion for treating ischemic stroke."
Previous studies have shown that Viprinex can be effective when
administered up to six hours after the onset of stroke symptoms, which could
significantly expand the number of people who can be treated. The only
currently approved drug therapy for ischemic stroke is limited to a three-hour
window.
With more than 700,000 patients experiencing stroke each year in the
United States, and existing therapies limited to the first three hours after
onset of stroke symptoms, there is a substantial unmet medical need to
increase treatment options that are safe and effective to more stroke
patients.
The Ancrod Stroke Program I and II studies are Phase 3 clinical trials
currently underway at sites in the United States, various European countries,
Russia, Australia, New Zealand, South Africa, Israel and Taiwan.
About Neurobiological Technologies:
Neurobiological Technologies, Inc. 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 with multiple mechanisms of action that is
specifically designed to double the time period that patients can be treated
after the onset of a stroke. NTI also has the right to receive royalty
payments from sales of Namenda(R) (memantine HCL), an approved drug marketed
for Alzheimer's disease, and the right to receive payments from the
development and marketing of XERECEPT(R) (corticorelin acetate injection), an
investigational drug in Phase 3 clinical development for swelling associated
with brain tumors. Additionally, NTI has rights to two compounds in
early-stage development for Alzheimer's and Huntington's diseases.
Forward Looking Statements:
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 successful
completion of clinical trials for Viprinex, as well as other risks detailed
from time to time in our Annual Report of Form 10-K and other filings with the
Securities and Exchange Commission. There can be no assurance that Viprinex
will prove to be safe or effective in the ongoing Phase 3 trials or that it
will receive regulatory approval for commercialization. Actual results may
differ materially from those projected. These forward-looking statements
represent our judgment as of the date of the release. We undertake no
obligation to update these forward-looking statements.
SOURCE Neurobiological Technologies, Inc.
