Viprinex Stroke Trials Get Phase III Nod
This article was originally published in The Pink Sheet Daily
Executive Summary
Snake venom injection widens ischemic stroke treatment window.
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Neurobiological Technologies is set to proceed with Phase III testing of the snake venom-based Viprinex in emergency stroke, after renewed approval from safety monitors. For the fifth time, an independent safety monitoring board has approved continuation of two Phase III controlled trials, the Emeryville, Calif.-based firm said April 16. Viprinex (ancrod), a late-stage reperfusion agent made from Malayan pit viper venom, is being administered intravenously within six hours of acute ischemic stroke in the studies, which involve 1,300 patients. The agent has been shown to reduce blood viscosity by up to 30 percent, but ran into safety problems earlier on in development when study participants were stricken with intracranial hemorrhage. In the new Phase III trials under way, the firm is using a lower dose to avoid such adverse events and expects to file an NDA in the first quarter of 2010. NTI picked up Viprinex via its 2004 buyout of Empire Pharmaceuticals, which had previously acquired the agent from Abbott (1 (Also see "Neurobiological To Revive Viprinex Stroke Trials Following Empire Acquisition" - Pink Sheet, 19 Jul, 2004.)). The firm focuses on central nervous system drug candidates, including two agents now in Phase III trials: Viprinex and Xerecept (cortecorelin) for brain tumor swelling. Its agent Namenda (memantine) for Alzheimer's disease is marketed by Forest Laboratories, of New York, in the U.S., while European sales are managed by Merz, of Frankfurt, Germany. On April 1, the company named a new chief financial officer: Matthew Loar, formerly of San Francisco-based Osteologix. - Emily Hayes ([email protected]) |