SOUTH SAN FRANCISCO, Calif., March 14 /PRNewswire-FirstCall/ -- Renovis, Inc. (Nasdaq: RNVS - News) today announced that preliminary results from the Phase IIb CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) safety and tolerability trial with the investigational drug, NXY-059, in acute intracerebral hemorrhage (ICH) were reported by its exclusive licensee, AstraZeneca. Although NXY-059 is in development for the treatment of Acute Ischemic Stroke (AIS), it was felt important to assess the safety and tolerability of NXY-059 in ICH as treatment may be initiated prior to a neuroimaging confirmation of the diagnosis of AIS. The data showed that the safety and tolerability of NXY-059 was similar to placebo, with comparable mortality rates (20% in each group) and no difference between the NXY-059 and placebo groups on the secondary endpoint of stroke outcomes after ICH in the study.
“Once again, we congratulate the development team at AstraZeneca for their outstanding efforts with the NXY-059 clinical program,” said Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. “The safety and tolerability of NXY-059 in ICH patients plays an important role in the overall development strategy for the drug. The CHANT results support our belief that NXY-059 may be applicable to a broad range of AIS patients.”
CHANT was a double-blind, randomized, placebo-controlled, parallel group, multi-center Phase IIb study conducted to evaluate the safety and tolerability of NXY-059 in patients with acute ICH. Stroke outcomes were explored as a secondary objective. Patients were randomized to receive 72 hours intravenous infusion of NXY-059 or placebo within six hours of ICH onset. A total of 603 patients from 20 countries were treated.
Commenting on the preliminary CHANT results, Dr. Tomas Odergren, Global Product Director for NXY-059 at AstraZeneca said, “Our evolving understanding of the safety and tolerability profile of NXY-059 in acute stroke conditions is enhanced greatly by the CHANT trial results. The results show that NXY-059 was well tolerated in the studied patients with Intracerebral Hemorrhage and that the overall safety profile was similar to the profile seen in Acute Ischemic Stroke patients in SAINT I. The potential implications on the way the drug may be used to treat AIS will be subject to the outcome of the second pivotal Phase III trial, SAINT II, and regulatory approvals.”
Safety and tolerability in the CHANT trial were assessed in terms of mortality, adverse events, neuroimaging scans, presence of abnormal findings on vital signs, laboratory assessments, and by electrocardiography (ECG). Stroke outcomes were explored using a range of stroke scales including the modified Rankin Scale (mRS), Barthel Index and National Institutes of Health Stroke Scale (NIHSS).
The Phase III SAINT trials (SAINT I and SAINT II) for NXY-059 in AIS are being conducted worldwide in approximately 400 centers across 40 countries to evaluate the effect of the compound in AIS patients. These countries and regions include: Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America. Data from SAINT I were initially reported in May 2005 and subsequently published in the New England Journal of Medicine in February 2006.
Dependent on the outcome of the ongoing SAINT II trial, AstraZeneca plans to file regulatory submissions for NXY-059 for AIS in Europe and the U.S. in the first half of 2007.
About Renovis
Renovis is a biopharmaceutical company primarily focused on the discovery and development of drugs for neurological diseases and disorders. Our most advanced product candidate, NXY-059, is in Phase III clinical trials for acute ischemic stroke with our exclusive licensee, AstraZeneca AB. NXY-059, an investigational drug under development by AstraZeneca and licensed from Renovis, has a proposed mechanism of action of free radical trapping. It is being studied as a neuroprotectant in clinical trials based on effects seen in experimental models of acute ischemic stroke. In addition to proprietary research programs in the areas of neuroprotection, pain and inflammation we have 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 http://www.renovis.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, plans and objectives of management are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Renovis cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors that could cause actual results or events to differ materially from the forward- looking statements that we make are described in greater detail in the “Risk Factors” section of our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 14, 2006. We do not assume any obligation to update any forward-looking statements.
Contacts: INVESTORS: MEDIA: Renovis, Inc. Noonan Russo John C. Doyle Jane Petrino (650) 266-1407 (212) 845-4274 doyle@renovis.com jane.petrino@eurorscg.com
Source: Renovis, Inc.
