Renovis announces results of phase 3 trial for NXY-059 for stroke

By Lisa Kerner

Erie, Pa., Feb. 8 - Renovis, Inc. said data from its phase 3 Saint 1 trial showed a statistically significant reduction with NXY-059 versus a placebo on the primary outcome of stroke-related disability, as assessed on the Modified Rankin Scale.

The data, published in the New England Journal of Medicine, is from the international Stroke Acute Ischemic NXY-059 Treatment trial (Saint) conducted by Renovis' exclusive licensee, AstraZeneca AB on the effect of NXY-059 (previously called Cerovive) for the treatment of acute ischemic stroke.

Additional analysis of the data showed 4.4% more patients treated with NXY-059 becoming free of symptoms and 3.7% more patients able to walk without help and being less dependent on others for bodily needs, compared to a placebo, according to a company news release.

Saint I was a double-blind, placebo-controlled phase 3 study, in which patients were randomized to receive NXY-059 or a placebo within six hours of acute ischemic stroke. Renovis said the 90-day study involved 1,722 patients in 158 centers from 24 countries.

NXY-059 did not significantly improve neurological function as measured in the prespecified analysis of Saint I data on the NIH stroke scale. The most common adverse events noted in the study were fever, constipation, headache, urinary tract infection, stroke in evolution, and hypokalemia, the company said.

"The Saint I data show clear and clinically important reductions in disability among patients treated with NXY-059 versus placebo," Renovis president and chief executive officer Corey Goodman said in the release.

"If these data are supported by the Saint 2 results, we believe that NXY-059 could become a broadly useful treatment for acute ischemic stroke patients."

The company said a second phase 3 study, Saint 2, which will involve 3,200 patients at approximately 350 centers around the world, is underway. Top line data from Saint 2 is due in the first half of 2007.

Renovis also expects results in the first quarter of 2006 from its Cerebral Hemorrhagic and NXY-059 Treatment trial, the so-called Chant trial. The double-blind, randomized, placebo-controlled, parallel-group, multi-center, phase 2b study is to assess the safety and tolerability of 72 hours intravenous infusion of NXY-059 in adult patients with acute intracerebral hemorrhage.

Renovis is a biopharmaceutical company based in South San Francisco.

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