RENOVIS ANNOUNCES EXPANSION OF PHASE III TRIAL WITH CEROVIVE
Renovis has announced that following consultations with regulators and the SAINT II trial Steering Committee its exclusive licensee for Cerovive, AstraZeneca, has increased the planned enrollment of the Phase III SAINT II trial to 3,200 patients from the originally planned 1,700 patients. Based on enrollment trends to date, this increase in trial size will move the anticipated regulatory filing date from the second half of 2006 to the second half of 2007. AstraZeneca is taking steps to increase the rate of enrollment into the SAINT II trial, including the addition of at least 10 countries that participated in the previously completed SAINT I trial. Data from the SAINT I trial showed a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke.
The increase in planned enrollment of SAINT II also improves the statistical powering of certain subgroup analyses. The statistical analysis plan for SAINT II has also been modified with respect to the prespecified analysis of patient outcomes as measured on the National Institutes of Health Stroke Scale, a key supportive efficacy endpoint intended to detect the effect of Cerovive on neurological impairment following acute ischemic stroke.
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