Cell Pathways (Horsham, PA) says it intends to file a new drug application with the FDA this summer following final positive data for exisulind, a pro-apoptotic compound for the treatment of adenomatous polyposis coli (APC). The target group of patients who formed 10–40 polyps per year—a 34-patient subgroup of the 65-patient trial—showed statistically significant (greater than 50%) reduction in new polyp formation when treated with exisulind as compared with placebo. The results contrast with disappointing preliminary analysis of phase III trial (Nature Biotechnol, 17, 220). However, in light of the relatively small number of patients who met inclusion criteria, the FDA has requested additional clinical data, which Cell Pathways says it will obtain from other ongoing APC trials.