Cerovive results . . . a tad confusing:
>>SOUTH SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Renovis, Inc. (Nasdaq: RNVS - News) 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 - News), 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® (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.<<
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Cheers, Tuck |
