Renovis stock collapses on NXY-059 Phase III efficacy results

SOUTH SAN FRANCISCO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- Renovis, Inc. announced today that a pivotal Phase III study of NXY-059 (SAINT II) conducted by its exclusive licensee, AstraZeneca, did not demonstrate a statistically significant reduction on the primary endpoint of stroke-related disability in patients treated with NXY-059, as assessed versus placebo using the modified Rankin Scale (mRS) (p=0.33, odds ratio 0.94).

On a secondary endpoint in the SAINT II study, treatment with NXY-059 did not result in a statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale (NIHSS) (p=0.70). There was also no evidence of NXY-059 lowering the incidence of symptomatic intracranial hemorrhage when administered with the approved thrombolytic agent, rt-PA (p=0.56). The incidence and profile of adverse events in patients in SAINT II receiving NXY-059 was similar to placebo. The mortality rate was also comparable in the treatment and placebo groups.

"We are obviously very disappointed by the lack of efficacy shown by NXY-059 in the SAINT II study," commented Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. "Stroke is an area of enormous medical need and we had hoped that NXY-059 might become an important new treatment option for patients and physicians. Unfortunately, the data are clear and although we will continue to review the results from SAINT I and SAINT II, we understand AstraZeneca's decision to discontinue development of NXY-059."

WHAT IS NXY-059 and HOW DOES IT WORK?
Increased free radical formation contributes to the damage caused to the brain by acute ischemia. NXY-059 is a nitrone-based free radical trapping agent in development for acute stroke. Free radicals are generated during brain ischemia and are implicated in the pathological events that lead to brain damage. Beneficial effects have been demonstrated both early and late, whether assessed by infarct volume measured histologically or by functional testing. Neuroprotection has been confirmed in more than one species, including primates, and validated in independent laboratories. Nitroxides and nitrones are stabilized forms of the biological messenger nitric oxide. They also have some unique properties. e.g. unlike other antioxidants, they generally neither act as proxidants, nor do they propagate free radical chain reactions. They inhibit superoxides.

Renovis (Nasdaq: RNVS)is down $10.62 which is roughly 75% in late afternoon trading.