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news.AtheroGenics' proposed amendment to the clinical protocol for its phase III trial of AGI-1067 in atherosclerosis has been approved by the FDA, meaning the company can now increase patient enrolment and otherwise enhance the trial.
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The phase III clinical trial, named ARISE, is testing AGI-1067, AtheroGenics’ lead compound for the oral treatment of atherosclerosis, in leading cardiovascular research centers throughout the US, Canada, the UK and South Africa.
The changes to the ARISE protocol are intended to enhance the trial as well as to accelerate its pace, without adversely affecting its special protocol assessment with the FDA. The changes approved by the FDA include a plan to increase the trial’s patient enrollment figure from 4,000 to 6,000.
Additionally, AtheroGenics has received FDA approval to decrease the trial’s target number of clinical events from 1,160 to 990. This revised target number will continue to yield greater than 95% statistical power to detect a 20% difference in clinical events between the study arms.
ARISE is expected to be completed by the end of the first quarter of 2006. AtheroGenics then plans to file a new drug application (NDA) with the FDA as soon as possible after the trial is completed and results have been analyzed.