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Renovis Announces that First Results from SAINT I Trial Show CEROVIVE (NXY-059) Demonstrated a Statistically Significant Reduction in Disability in Patients with Acute Ischemic Stroke
SOUTH SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Renovis, Inc. (Nasdaq: RNVS) announced today that a first analysis of data from the Phase III SAINT I trial involving more than 1,700 patients conducted by its licensee, AstraZeneca (NYSE: AZN), shows a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke (p= 0.038), as measured by the Modified Rankin Scale (MRS). However, on the National Institute of Health Stroke Scale (NIHSS), there was no significant difference in measurement of change in neurological impairment between the treatment groups. The clinical significance of these findings need to be assessed in light of the outcome of SAINT II and CHANT.
Half of the trial's 1,700 patients were randomized to receive CEROVIVE(R) (NXY-059). The incidence and profile of adverse events was similar to placebo.
The Phase III SAINT II trial will enable AstraZeneca to complete its evaluation of the efficacy and safety profile of CEROVIVE (NXY-059) in acute ischemic stroke patients. AstraZeneca plans to file regulatory submissions in the second half of 2006. Such filings for CEROVIVE will be dependent on the final data package, including results from SAINT II and CHANT.
"These data represent a real achievement in the development of neuroprotective agents for stroke," said Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. "CEROVIVE (NXY-059) is the first neuroprotectant treatment for acute ischemic stroke to show a statistically significant reduction of disability in a pivotal trial of the size and scope of SAINT I. We congratulate the development team at AstraZeneca for their exceptional work and on the importance of their contribution to the treatment of acute ischemic stroke, a condition for which there are very few safe and effective treatment options currently available."
Commenting on the preliminary data from SAINT I, Dr. Tomas Odergren, Global Product Director for CEROVIVE (NXY-059) at AstraZeneca said, "We are encouraged by these data and what this could mean for stroke patients, as acute ischemic stroke is a condition for which an effective and well tolerated treatment is urgently needed. However, the full potential of CEROVIVE will only be clear after completion of the clinical development program."
The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide in approximately 400 centers across 40 countries to evaluate the effect of the compound in acute ischemic stroke patients. These countries and regions include: Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America. The safety of patients included in the trials is being evaluated continually.
Additionally, the CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial will continue as planned. CHANT is a double-blind, randomized, placebo- controlled, parallel group, multi-center, Phase IIb study being conducted by AstraZeneca to assess the safety and tolerability of CEROVIVE (NXY-059) in adult patients with acute intracerebral hemorrhage. The independent data safety monitoring board recently conducted a planned safety review on the first 200 patients and recommended the trial to proceed according to plan. The trial will involve approximately 150 centers in 21 countries.
CEROVIVE (NXY-059), an investigational drug under development by AstraZeneca and licensed from Renovis, Inc., 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.
Renovis is a biopharmaceutical company developing drugs to treat neurological diseases and disorders. Our most advanced product candidate, CEROVIVE(R) (NXY-059), is in Phase III clinical trials for acute ischemic stroke with our exclusive licensee, AstraZeneca AB. CEROVIVE (NXY-059), an investigational drug under development by AstraZeneca and licensed from Renovis, Inc., 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. We are independently developing REN-1654, an oral drug candidate for neuropathic pain in a Phase II clinical trial for sciatica and REN-850, an oral drug candidate for multiple sclerosis in a Phase I clinical trial. Our research and development programs focus on major medical needs in the areas of neuroprotection, pain and neuroinflammatory diseases.
For additional information about the company, please visit http://www.renovis.com.
CEROVIVE (NXY-059) is a registered trademark of the AstraZeneca group of companies. All other product names and marks are or may be trademarks or registered trademarks used to identify products or services of their respective owners.
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, future revenues, projected costs, prospects, 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 could cause actual results or events to differ materially from the forward-looking statements that we make, including risks related to: our heavy dependence on the success of CEROVIVE (NXY-059), which is still under development; our dependence on our strategic collaboration with AstraZeneca; AstraZeneca's success in obtaining regulatory approval to market CEROVIVE (NXY-059); our ability to successfully develop other product candidates, such as REN-1654 and REN-850; obtaining, maintaining and protecting the intellectual property incorporated into our product candidates; and our ability to obtain additional funding to support our business activities. These and other risks 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 28, 2005. Our forward- looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements.
* Modified Rankin Scale (MRS): the most commonly used global disability scale for assessing stroke patients. It is a simple measure of independence primarily used in the rehabilitation phases of stroke.
* National Institute of Health Stroke Scale (NIHSS): provides a quantitative assessment of the neurological examination findings that are most relevant to stroke patients. This scale assesses neurological impairment, providing a measure of the severity of the stroke and was developed specifically for use in acute stroke trials.
SOURCE Renovis, Inc.
05/04/2005
Investors, John C. Doyle, Renovis, Inc., 650-266-1407, doyle@renovis.com; or
media, Emily Poe, Noonan Russo, 212-845-4266, emily.poe@eurorscg.com
/Web site: http://www.renovis.com /
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