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Neurobiological Technologies, Inc. Presents Dosing Rationale For Viprinex(TM) (ancrod) At The European Stroke Conference
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.
Neurobiological Technologies, Inc.
http://www.ntii.com
View drug information on Namenda.
Neurobiological Technologies, Inc dozare a prezentat argumente pentru Viprinex (tm) (ancrod) European de la accident vascular cerebral de conferinte - Neurobiological Technologies, Inc. Presents Dosing Rationale For Viprinex(TM) (ancrod) At The European Stroke Conference - articole medicale engleza - startsanatate