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Renovis says phase 3 results for stroke neuroprotectant agent expected in fourth quarter
By E. Janene Geiss
Philadelphia, June 8 - Renovis, Inc. said Thursday that it expects to report top-line results from the pivotal Saint II trial with NXY-059 in coordination with its exclusive licensee, AstraZeneca AB, during the fourth quarter of 2006.
The trial is a double-blind, placebo-controlled phase 3 study in which patients are randomized to receive NXY-059 or a placebo within six hours of acute ischemic stroke, according to a company news release.
The study is designed to confirm the results of the previously completed phase 3 pivotal Saint I trial, which met the primary endpoint of reduced patient disability versus a placebo following acute ischemic stroke, as assessed on the Modified Rankin Scale.
Subject to successful completion of Saint II, AstraZeneca said it intends to submit applications for regulatory approval of NXY-059 in the United States and Europe in the first half of 2007.
The company said it expects to complete enrollment in the Saint II trial ahead of schedule this month with about 3,200 patients from more than 350 centers in 30 countries.
If the data are positive, Renovis said it believes that NXY-059 could fundamentally change the standard of care of acute ischemic stroke patients by allowing treatment of a broad population of patients in a wide array of clinical settings.
NXY-059 is a free radical trapping neuroprotectant and the first compound that has been publicly recognized by the Stroke Treatment Academic Industry Roundtable of academic and industry experts to meet their criteria for development of neuroprotective agents.
AstraZeneca is a London pharmaceutical and health care company.
Renovis is a biopharmaceutical company focused on neurological diseases and disorders.
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