AtheroGenics restenosis drug effective in Phase II

Preliminary results from a Phase II study of AtheroGenics'orally-active antioxidant AGI-1067 have suggested that the drug can reduce restenosis in patients undergoing percutaneous transluminal coronary angioplasty. Six months after PTCA, patients who took a range of doses of AGI-1067 on a daily basis had, on average, greater luminal diameters in their coronary arteries than those who received placebo. AtheroGenics licensed worldwide rights to the drug to Schering-Plough in 1999 in a deal worth up to $189 million.

At the highest dose examined in the trial, known as CART-1, AGI-1067 achieved an increase in target blood vessel size similar to that reached with another antioxidant agent, probucol, which was included in the study as an active control. Probucol featured in the MVP study, which also looked at the role of vitamin E in preventing restenosis in this setting. In this latter trial, published in 1997, vitamin E was found to have no effect, while probucol was associated with a significant reduction in restenosis.

Importantly, AGI-1067 did not appear to be associated with the cardiovascular effects (QT prolongation) which have been seen with probucol.