AstraZeneca Cerovive stroke data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
AstraZeneca plans to submit its neuroprotectant Cerovive (NXY-059) for disability reduction in patients with acute ischemic stroke in the second half of 2006, the firm says May 4. AZ reported preliminary results of a pivotal trial (SAINT I) in which the free radical trapping agent showed a significant disability reduction versus placebo on the Modified Rankin Scale (p=0.038). However, "on the National Institute of Health Stroke Scale, there was no significant difference" between Cerovive and placebo. "The clinical significance of these findings need to be assessed in light of the outcome" of the ongoing SAINT II and CHANT trials. AstraZeneca is developing Cerovive with Renovis...