Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced today the last patient has completed the study protocol in its pivotal Phase 3 trial of CPP-1X/sul for adults with familial adenomatous polyposis (FAP), a rare genetic disease that, if left untreated, progresses to colorectal cancer in nearly 100% of patients.
Analysis of the results from the randomized, double-blind trial are expected to be complete in early 2019, followed by potential submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA), which has granted CPP-1X/sul for the treatment of FAP fast track and orphan drug designation.
“This is a significant milestone in our development of CPP-1X/sul,” said CPP Chairman and CEO Jeff Jacob. “It has taken five years across multiple sites in the United States, Canada and Europe to complete the trial. We look forward to bringing to FAP patients a pharmaco-prevention therapeutic that, if approved, could change the treatment paradigm for their debilitating and life-threatening disease.”