Renovis Announces Positive First Results From SAINT I Trial of Cerovive

Renovis has announced that a first analysis of data from the Phase III SAINT I trial involving more than 1,700 patients conducted by its licensee, AstraZeneca, shows a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke, as measured by the Modified Rankin Scale.

However, on the National Institute of Health Stroke Scale, there was no significant difference in measurement of change in neurological impairment between the treatment groups. The clinical significance of these findings needs 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.