Cancer Prevention Pharmaceuticals Inc. (CPP) is a private biotech company working on innovative therapeutics designed to prevent cancer and other diseases. Their latest product, CPP-1X/sul, was specifically developed for patients with familial adenomatous polyposis (FAP), a rare genetic disease that directly leads to colorectal cancer if left untreated.
“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”, noted Jeff Jacob, Chairman, and CEO of CPP. “This is a significant milestone in our development of CPP-1X/sul”.
Clinical trials enrolled 171 patients from 17 research institutes across the United States, Canada and Europe. They evaluated CPP-1X (eflornithine) in combination with sulindac as single agents in delaying time to the first occurrence of any FAP-related event.
Familial adenomatous polyposis is generally an inherited condition caused by a defect in the adenomatous polyposis coli (APC) gene. It induces extra tissue (polyps) to form in the large intestine and typically becomes cancerous. In some cases, the genetic mutation can occur spontaneously.
Estimates show that FAP affects about 1 in 10.000 people. Patients are often subjected to a lifetime of periodic monitoring as well as surgeries. These include the removal of the colon, rectum, surgical pouch, duodenum and/or high-risk adenomas.
“If the study results are favorable and CPP-1X/sul is approved by the FDA, clinicians will be able to offer their FAP patients a safe and effective drug treatment that may reduce or potentially avoid the need for complex endoscopic or surgical intervention”, said Carol A. Burke, MD, principal investigator for the study and gastroenterologist at the Cleveland Clinic.