CPP-1X/sul treatment familial adenoma polyps application for listing delayed colorectal surgery.

FAP is a rare genetic disorder, and it is more common, polyps can be covered with the colon and rectum, with a high risk of cancerIf left untreated, almost 100% of patients develop colorectal cancerTypical FAP patients, in adolescence began to have multiple non-cancerous (benign) growth of polyps in the colon, the number of polyps with age increase, can reach hundreds of thousandsThe average age of colorectal cancer in typical FAP patients is 39For most FAP patients, current medical practices include lifelong periodic monitoring and highly invasive surgeryCPP-1X/sul is a fixed-dose combination of CPP-1X (eflornithine, efluorobirdine) and sulindac, and is currently developing a potential drug preventive therapy for FAP patientsIf approved, CPP-1X/sul will provide an alternative to surgery for THE FAP patient population, significantly improving their quality of lifeIn clinical trials, cPP-1X/sul significantly delayed the need for large surgery in the colon, rectum or cystic bag compared to CPP-1X or sulindac after up to 4 years of treatmentThe drug is expected to soon be used as an adjunct therapy for the management of FAP patients facing large intestine surgeryIn a clinical trial of patients with large intestine polyps, the CPP-1X/sul combination prevented more than 90 percent of precancerous adenomas compared to placebosBased on biological similarity with FAP, a key Phase III trial CPP FAP-310 separately compared CPP-1X/sul with each drug in the portfolioThe trial recruited 171 FAP patients at 17 research centers in the United States, Canada and EuropeThis is the largest prospective controlled study ever conducted in a 48-month study of treated FAP patients, much longer than any other clinical trial in this groupThe purpose of the study was to determine whether CPP-1X/sul was superior to CPP-1X or sulindac single formulation spent on delaying the first time of any FAP-related events(e., colon and rectal excision, cystic bags, duodenal and/or high-risk adenoma surgery)The trial design incorporates FAP patients with a variety of upper and lower gastrointestinal (GI) diseasesThe data showed that CPP-1X/sul performed better than a single drug in the overall study population, but was not statistically significantHowever, further analysis of the data found that CPP-1X/sul showed key differential effects for the anatomy of the lower and upper digestive tracts For patients with lower digestive tract anatomy (colon integrity, rectum retention, or cystic bag), the data showed that CPP-1X/sul had significant statistical significance for delayed undergoing gastrointestinal surgery events for up to 4 years compared to two single drugs (p.02) In addition, the safety of the CPP-1X/sul combination is not significantly different from the known safety of a single drug, supporting the overall safety of long-term use of this fixed-dose combination product Original source: Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis Source: Familiadenomatos Polyposis New Drug: Fayadoma Polyps! CPP-1X/sul (efluorobirdine/shurin) Us and Europe apply for listing, delayed colorectal surgery!