AtheroGenics Inc announced the initiation of a Phase IIb clinical trial of its proprietary v-protectant drug, AGI-1067, for the treatment of restenosis and atherosclerosis. This clinical trial, the Canadian Antioxidant Restenosis Trial-2 (CART-2), will continue to explore the drug's positive effect on reducing restenosis by extending the duration of dosing, and will further investigate the apparent impact of AGI-1067 on the reversal of atherosclerosis, as revealed in a post-study analysis of the CART-1 data.

"CART-2 will build upon the promising and profound results demonstrated by AGI-1067 in the CART-1 trial," said principal investigator Jean-Claude Tardif, of the Montreal Heart Institute. "While AGI-1067 was effective in reducing restenosis in the CART-1 trial with only six weeks of dosing, our hypothesis is that this positive effect can be substantially enhanced by a longer course of therapy. In addition, the reversal of atherosclerotic progression will be of significant focus, as it represents a potentially groundbreaking therapy where no comparable treatment exists."

The Phase IIb study will enroll 500 patients in approximately 24 clinical sites, and feature a 12-month-long dosing regimen of AGI-1067 at 280mg. As the CART-1 trial featured two-week pre-procedure dosing, the new trial will also examine the need, if any, for pre-dosing.

"We are committed to aggressively advancing the AGI-1067 clinical development program not only as a potential treatment for restenosis, but also for atherosclerosis," said Russell M. Medford, President and Chief Executive Officer of AtheroGenics. "The timelines that we established for initiating this trial were extremely tight, and I'm pleased to report that our organization has risen to the task. We have worked closely with cardiovascular experts to design this trial, and positive results should pave the way for launching a pivotal Phase III trial in 2003."