Pharmacology
FDA Approves Phase III Amendments for Drug Intended for Oral Treatment of Atherosclerosis
By Akanksha, Pharmacology Correspondent
Feb 23, 2005, 08:14

AtheroGenics,Inc. a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its proposed amendment to the ARISE Phase III clinical trial protocol.

The ARISE Phase III clinical trial is testing the Company's lead compound, AGI-1067 ,for the oral treatment of atherosclerosis in leading cardiovascular research centers throughout the United States, Canada, the United Kingdom 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 the Company's plan to increase the trial's patient enrollment figure from 4,000 to 6,000. With this increase, the study will now accumulate 10,000 patient-years of exposure over the course of the trial. AtheroGenics estimates that ARISE will achieve full patient enrollment by mid-2005.Given the increased size and longer duration of the trial, the Company has also received FDA approval to eliminate the minimum 12-month follow-up period for patients.

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 percent statistical power to detect a 20 percent difference in clinical events between the study arms.

ARISE is expected to be completed by the end of the first quarter of 2006.The Company 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.

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