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Phase 3 Trial of Cerovive To Continue After Interim Data Analysis
The decision follows a recent IDMB interim analysis of these trials, which included data on stroke outcomes after a three-month follow-up period in 1,000 patients. The purpose of this analysis was to assess whether it would be futile (not meaningful) to continue patient enrollment in the SAINT trials when looking at the degree of post-stroke disability experienced by patients who received drug as compared to patients who received placebo, and to determine if there were safety concerns.
The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide and planned to enroll subjects in approximately 400 centers across 40 countries (Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America) to evaluate the effect of the compound in acute ischemic stroke patients. The safety of patients included in the trials is being continually evaluated.
"This interim analysis was the first time in the SAINT trials that the IDMB reviewed patient outcomes in addition to safety data for CEROVIVE (NXY- 059)," said Corey Goodman, Ph.D., CEO of Renovis. "The IDMB's positive recommendation represents another encouraging milestone in the development of CEROVIVE (NXY-059) for the treatment of stroke patients."
Commenting on this news, Tomas Odergren, M.D., Global Product Director for CEROVIVE (NXY-059) at AstraZeneca said, "AstraZeneca is pleased to learn the IDMB's recommendation to continue the SAINT trials as planned. Like Renovis, AstraZeneca is committed to the research and development of new therapies that have the potential to improve patients' lives and will continue to work closely with the IDMB and trial Steering Committee to ensure the best possible chance of success for CEROVIVE (NXY-059)."
Additionally, the CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial initiated enrolment in August 2004. CHANT is a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 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. The trial will involve approximately 150 centers in 21 countries.
CEROVIVE (NXY-059), a neuroprotectant with free-radical trapping properties, is a drug under development by AstraZeneca and licensed from Renovis, Inc.