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The data, presented today at the 6th World Stroke Conference in Vienna,Austria, are from a retrospective analysis led by NTI scientists of twoprevious Phase 3 clinical trials, known as STAT and ESTAT, which involved morethan 1700 patients and were conducted before NTI acquired the rights toancrod. The STAT trial in the United States showed ancrod-treated patients hada better outcome than placebo-treated patients, while the European ESTAT trialshowed an ancrod treatment outcome similar to placebo, but a higher rate ofsymptomatic intracranial hemorrhages. When the drug safety information fromthe trials were compared, it was noted that patients treated with ancrod inESTAT who had symptomatic intracranial hemorrhages were more likely to havehad prolonged low fibrinogen blood levels, to have received higher doses ofancrod and to have had higher blood pressures at trial entry.
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"The conclusions of this analysis provided NTI with the information neededto revise the dosing regimen to avoid prolonged low fibrinogen levels andlaunch new Phase 3 clinical trials using common blood pressure patient-entrycriteria," says Gregory del Zoppo, M.D. of the University of Washington,chairman of the current ancrod clinical trials' steering committee, and acoauthor of the retrospective analysis.
"Earlier Viprinex trials used a dosing regimen that infused the drug overfive to seven days, which kept blood fibrinogen levels low for too long," saidDavid Levy, Vice President, Clinical Development of NTI, who led the analysis."We changed the treatment paradigm to a three-hour infusion which has beendesigned to reduce fibrinogen levels quickly, while also avoiding prolongedlow fibrinogen levels as seen in the ESTAT data."
Using the revised dosing regimen, NTI is currently conducting two Phase 3clinical trials of Viprinex to investigate whether ancrod can safely andeffectively reduce disability following an acute ischemic stroke. The trialsare being conducted in 14 countries throughout the world, and to date haveenrolled over 500 patients. NTI believes that Viprinex can be administered upto six hours after the onset of stroke symptoms, significantly expanding thenumber people who can be treated compared to the single currently approveddrug for the treatment of stroke in the U.S.
Viprinex (ancrod) is a novel Fibrinogen Reducing Agent (FRA), the activeingredient of which is an enzyme that reduces blood levels of fibrinogen, theprimary protein involved in blood clotting. It is derived from Malayan pitviper venom and is highly specific for fibrinogen.
Previous research suggests that Viprinex may work in three ways to improveblood flow to areas of the brain affected by the stroke by:
-- Interfering with fibrinogen's ability to participate in blood clotformation, which should limit clot growth and reduce odds of reocclusion dueto new clots.
-- Reducing blood viscosity (resistance to flow), which should improveblood 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 thestroke.
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc., (Nasdaq: NTII) is a biopharmaceuticalcompany focused on developing novel, first-in-class agents for central nervoussystem conditions and other serious unmet medical needs. The Company's mostadvanced product candidate, Viprinex(TM) (ancrod), is in P
