NXY-059 Does Not Meet Efficacy Endpoints in Phase III Trial for Acute Ischemic Stroke
Thursday October 26, 2:01 am ET
--Conference call scheduled for 8:30am EDT, October 26, 2006--
SOUTH SAN FRANCISCO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- Renovis, Inc. (Nasdaq: RNVS - News) 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."
Dr. Goodman continued, "We have managed our resources carefully so that Renovis is in a strong financial position to continue our unpartnered drug discovery programs targeting major medical needs in inflammatory and neurological diseases. In addition, our partnerships with Pfizer and Genentech continue on track. We expect that a compound from our collaboration with Pfizer to develop VR1 antagonists for pain will enter the clinic in 2007."
Updated Conference Call and Webcast Information
Corey S. Goodman, Ph.D., President and Chief Executive Officer, and John C. Doyle, Senior Vice President of Finance and Operations and Chief Financial Officer, will discuss recent developments involving NXY-059 and the SAINT II trial and review third quarter 2006 results via webcast and conference call on October 26, 2006 at 8:30 a.m. EDT. Interested parties may access the call by dialing 1-800-299-9630 in the United States and 1-617-786-2904 internationally. The participant code is 75531115. A replay of the call may be accessed by dialing 1-888-286-8010 or 1-617-801-6888. The participant code for the replay is 40477873. This call is being webcast by Thomson and can be accessed in the Investor Relations section of the Renovis web site at www.renovis.com. A replay of the webcast will be available until November 2, 2006.
About Renovis
Renovis is a biopharmaceutical company focused on the discovery and development of drugs for major medical needs in the areas of neurological and inflammatory diseases. In addition to proprietary research programs in the areas of neurological and inflammatory diseases, Renovis has a worldwide collaboration and license agreement with Pfizer to research, develop and commercialize small molecule VR1 antagonists, and a research and development collaboration with Genentech to discover and develop anti-angiogenesis drugs and drugs that promote nerve re-growth following nervous system injury.
For additional information about the company, please visit www.renovis.com. |
