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Enrollment completed for phase 3 trial of CPP-1X/sulindac in familial adenomatous polyposis
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Target enrollment has been reached for the CPP FAP-310 trial, a phase 3 clinical trial evaluating CPP-1X/sulindac combination therapy in adults with familial adenomatous polyposis, according to a press release from the drug maker.
CPP-1X/sulindac (Cancer Prevention Pharmaceuticals) — developed as a pharmaco-prevention therapy — aims to reduce the progression of polyps and tumors associated with the rare genetic disease.
“The completion of target enrollment in this pivotal phase 3 clinical trial is an important milestone for the non-invasive treatment of FAP, and we look forward to completing the trial and bringing to market a first-in-class pharmaco-prevention therapeutic,” Jeffrey Jacob, CEO of Cancer Prevention Pharmaceuticals, said in the press release. “For this clinical trial, we have worked closely with many groups, including the U.S. Food and Drug Administration and the European Medicines Agency to develop clinically-relevant trial endpoints, with top clinical researchers and medical centers in the design and implementation of the trial, and with patient advocacy organizations to support awareness of the trial in the FAP community.”
CPP FAP-310 is a randomized, double blind trial evaluating if combination therapy with CPP-1X and sulindac delays time to disease progression and resulting events related to the disease, such as the need for surgery or endoscopic procedures, according to the press release. The 166 patients enrolled at 21 research centers in the U.S., Canada and Europe will receive CPP-1X/sulindac daily for 2 years, and during this period the time to first occurrence of any event related to FAP will be evaluated.
“FAP patients face a lifetime of complex endoscopic and invasive surgical procedures, including colectomy, proctectomy and duodenectomy, which begin in the teenage years and progressively remove the colon, rectum and duodenum as the disease evolves,” Alfred Cohen, MD, chief medical officer of Cancer Prevention Pharmaceuticals, said in the press release. “The intent of this clinical trial is to provide FAP patients an approved, once-daily dosing to intervene in the disease's progression and defer major medical interventions.”
Disclosure: Cohen and Jacob are employed by Cancer Prevention Pharmaceuticals.