Phase III trial of CPP-1X/sulindac fails to meet endpoint in familial adenomatous polyposis

Cancer Prevention Pharmaceuticals announced that CPP's pivotal phase III clinical trial, CPP FAP-310, of the investigational drug CPP-1X/sulindac in patients with familial adenomatous polyposis (FAP), did not meet its primary endpoint. Specifically, the reduction of time to the first occurrence of an FAP-related event for the combination of CPP-1X (eflornithine) and sulindac (a nonsteroidal anti-inflammatory drug) did not reach statistical significance compared to the two control arms.

CPP FAP-310 included only active comparator arms and was the largest and longest study ever conducted in patients with FAP. The results showed CPP-1X/sul was well tolerated and activity was observed in some patients, including strong signals for delaying the need for colon surgery. but Based on the topline results, Mallinckrodt does not plan to pursue the commercialization of the CPP-1X/sulindac program.