Cancer Prevention Pharmaceuticals (CPP) has completed the target enrolment for its phase 3 clinical trial, CPP FAP-310, for assessing CPP-1X/sulindac in adults with familial adenomatous polyposis (FAP).
FAP is a rare genetic disease that commonly develops into colorectal cancer if untreated.
For the trial, CPP has enrolled 166 patients at 21 research institutes in the US, Canada and Europe.
CPP is currently developing CPP-1X/sulindac as a pharmaco-prevention therapy that is designed to reduce the progression of polyps and tumours related to FAP.
A randomised, double-blind, phase 3 clinical trial, CPP FAP-310 aims to find out in FAP patients if the combination of CPP-1X and sulindac delays the time to disease progression and subsequent FAP-related events, including the need for surgical and endoscopic procedures.
Patients undergoing the clinical trial will receive two years of daily treatments of CPP-1X/sulindac, and time to the first occurrence of any FAP-related event is evaluated during this two-year period.
Cancer Prevention Pharmaceuticals CEO Jeffrey Jacob said: "The completion of target enrolment 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.
"For this clinical trial, we have worked closely with many groups, including the US Food and Drug Administration and the European Medicines Agency to develop clinically relevant trial endpoints, with top clinical researchers and medical centres in the design and implementation of the trial, and with patient advocacy organisations to support awareness of the trial in the FAP community."
The company said that patients with typical presentation of FAP experience a genetic mutation that conveys an extremely high-risk of developing colon cancer, and they start to develop multiple benign polyps in the colon in their early teens.
Ultimately, the colon becomes carpeted with hundreds to thousands of polyps, with some becoming become cancerous if not treated.
For most FAP patients, existing medical practice suggests the surgical removal of the colon and sometimes the rectum followed by a lifetime of monitoring of the upper GI, retained rectum or ileal pouch, additional operations and a reduced quality of life.