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news.AstraZeneca has increased the planned enrollment of a phase III trial investigating the benefits of Cerovive, a neuroprotectant, to 3,200 participants, moving the expected filing date for the drug to 2007.
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The trial, part of a collaboration between AstraZeneca and Renovis, was originally expected to enroll 1,700 patients. The companies believe that 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 trial, including the addition of at least ten countries that participated in previously completed trials.
The initial study, called the Saint I trial, produced very promising results showing the drug to significantly reduce disability after an acute ischemic stroke.
Dr Corey Goodman, president and CEO of Renovis said: “While the increase in planned enrollment for Saint II will change the timeline of regulatory filings for Cerovive, 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.”