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Cancer Prevention Pharmaceuticals announces last patient completes phase 3 trial protocol of CPP-1X/sul for familial adenomatous polyposis
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.
“Patients currently suffering from FAP have no effective treatments to delay or prevent progression of their disease,” said Carol A. Burke, MD, a gastroenterologist at the Cleveland Clinic and principal investigator for the FAP-310 clinical trial.
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