IDMC recommends continuation of Cancer Prevention's Phase III FAP trial

Cancer Prevention Pharmaceuticals Inc. (Tucson, Ariz.) said an IDMC recommended continuation of the Phase III CPP FAP-310 trial evaluating eflornithine/sulindac (DFMO/sulindac, CPP-1X/sulindac) to treat familial adenomatous polyposis (FAP). The product is a combination of eflornithine (difluoromethylornithine, DFMO), a selective inhibitor of ornithine decarboxylase (ODC), and sulindac, a generic NSAID.

The double-blind, international trial enrolled 171 FAP patients and is comparing 750 mg oral eflornithine once daily plus 150 mg oral sulindac once daily vs. each of its components -- eflornithine or sulindac -- for 2 years. The primary endpoint is time to first occurrence of any FAP-related event. Secondary endpoints include presence or absence of an ODC polymorphism and excretion of 4 urinary polyamines...