Good news for patients with familial adenomatous polyposis! FDA opens fast track channel for orphan drug cpp-1x / sul

Source: 2017-09-20 CPP (cancer prevention pharmaceuticals, Inc) is a company focusing on the research of tumor drugs and other drugs Yesterday, FDA announced that it will open a fast tracking channel for cpp-1x / Sul, a company's drug for the treatment of adult familial adenomatous polyposis The research and development of cpp-1x / Sul is in phase III clinical trials FAP is a rare genetic disease If not treated in time, almost 100% of patients suffer from colorectal cancer There is no effective FAP treatment The FDA has previously approved cpp-1x / Sul as an orphan drug for FAP treatment FDA's fast track channel aims to speed up the review of drugs for treating serious diseases, so as to meet the medical needs that cannot be met by current therapies, and its purpose is to provide effective new drugs for patients as soon as possible At present, cpp-1x / Sul is also included in this fast tracking channel, which will greatly promote the research and development process of cpp-1x / Sul Jeff Jacobs, chairman and CEO of CPP, said: "the FDA's decision to quickly track cpp-1x / Sul is good news for FAP patients who do not currently have any approved treatment This also means that the road of commercialization of CPP is being paved Our partner, sucampo pharmaceutical, will also continue to support us in promoting the early completion of the fap-310 clinical trial In the future, after cpp-1x / Sul is approved for marketing, it will provide first-class drug prevention and treatment for patients with FAP " In January 2016, CPP and sucampo signed a US $8 million cooperation agreement, which grants the exclusive authorization to the cpp-1x / Sul drugs of sucampo company At the same time, sucampo company will contribute to the commercialization of cpp-1x / Sul in North America Recently, sucampo also paid CPP $9.5 million (approximately $4.5 million in option fees and $5 million in convertible notes) Fap-310 clinical trial is a randomized, double-blind, phase III clinical trial The purpose is to determine whether the combination of eflornithe and sulindac is better than the combination of eflornithe and sulindac in the treatment of FAP patients In June this year, an independent data monitoring committee conducted an invalid analysis on the trial conducted by cpp-1x / Sul, and then recommended to continue the clinical phase III trial of cpp-1x / Sul The test has been registered and is expected to be completed in 2018.