Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020

Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).

FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.

“The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”

Spotlight

Flow Cytometry is a critical and informative part of all phases of drug development. Knowing which assays to run at each critical stage gate, can streamline your journey to the successful development of your therapeutic.

Spotlight

Flow Cytometry is a critical and informative part of all phases of drug development. Knowing which assays to run at each critical stage gate, can streamline your journey to the successful development of your therapeutic.

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