Analysis of Earlier European Stroke Trial Supports Treatment Regimen for Viprinex(TM) in Current International Phase 3 Clini...( EMERYVILLE Calif. Sept. 25 /- Neu...),Health

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
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