Cancer Prevention Pharmaceuticals (CPP) and Mallinckrodt Announce Results from Pivotal Phase 3 Trial of CPP-1X/Sulindac in Patients With Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals, Inc., a private biotech company developing novel therapeutics to prevent cancer and other diseases, and its partner Mallinckrodt Plc, 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.

“While we are disappointed that the CPP FAP-310 clinical trial did not achieve its primary endpoint, we are encouraged by the data that relate to important outcome measures,” said CPP CEO Jeff Jacob.