Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, today announced The New England Journal of Medicine (NEJM) has published results from its landmark FAP-310 Phase 3 clinical trial of CPP-1X/sul as a pharmaco-preventive treatment for adults with familial adenomatous polyposis (FAP).
TUCSON, Ariz. and STAINES-UPON-THAMES, United Kingdom, May 7, 2019 /PRNewswire/ -- Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, and its partner Mallinckrodt Plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that CPP's pivotal phase 3 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.