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Analysis of Earlier European Stroke Trial Supports Treatment Regimen for Viprinex(TM) in Current International Phase 3 Clinical Trials
Date:9/25/2008

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.

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