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Phase 3 Trial of Cerovive Expands Patient Enrollment
"SAINT I was the first-ever trial of a neuroprotectant that reached a statistically significant positive result on the primary endpoint," stated Dr. Tomas Odergren, Global Product Director for CEROVIVE (NXY-059) at AstraZeneca. "The insight gained from this result has been carried over to the SAINT II trial to improve the statistical powering of this trial to confirm the clinically significant level of benefit seen in the SAINT I trial. This change was made after consultation with regulators and the trial Steering Committee."
"We are very pleased that AstraZeneca has decided to invest significant additional resources in the SAINT II trial to provide added assurance that this second Phase III trial with CEROVIVE (NXY-059) will duplicate the success of the SAINT I trial by also showing a statistically significant reduction of disability after acute ischemic stroke," stated Corey S. Goodman, Ph.D., President and Chief Executive Officer of Renovis. "While the increase in planned enrollment for SAINT II will change the timeline of regulatory filings for CEROVIVE (NXY-059), Renovis and AstraZeneca believe that this change is a critical step toward fulfilling the urgent need of acute ischemic stroke patients for an effective and well tolerated treatment."
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 (NIHSS), a key supportive efficacy endpoint intended to detect the effect of CEROVIVE (NXY-059) on neurological impairment following acute ischemic stroke.
"We are pleased that patient outcomes on the NIHSS in SAINT II will be measured in a manner that is appropriate to the nature of the data collected and that is consistent with the analysis method applied to the pre-specified primary endpoint in the trial."
Separately, AstraZeneca will continue as planned with the CHANT trial, which is a Phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of CEROVIVE (NXY-059) in adult patients with acute intracerebral hemorrhage. This decision is based upon a recommendation from the Independent Data and Safety Monitoring Board (IDMB) and the trial Steering Committee following a planned interim analysis of safety data from 400 patients. CHANT is planned to involve a total of approximately 600 patients. We currently expect to report results from the CHANT trial in coordination with AstraZeneca during the first half of 2006.
Source: Renovis, Inc.