AtheroGenics: Faster than anticipated

In drug development, it may be hard to show statistical benefit for completely unexpected reasons, usually bad. But when AtheroGenics Inc. reported preliminary Phase II data for its AGI-1067 to prevent post-angioplasty restenosis, the company said it was unable to say whether the trial met its primary end point due an unexpected apparent biological benefit of the compound.

AGI-1067 is an oral small molecule that blocks expression of adhesion molecules. As reported last week, the 305 patients in AGIX's CART-1 study (Canadian Antioxidant Restenosis Trial) received AGI-1067, placebo or probucol for two weeks leading up to angioplasty, and for four weeks post-angioplasty. The primary end point was luminal diameter of vessels in AGI-1067 patients compared to those of placebo patients six months after the procedure (see B9). ...