Cequent Pharmaceuticals announced this week that its new drug application for an oral RNAi-based treatment for advanced familial adenomatous polyposis has been approved by the US Food and Drug Administration.
FAP is an inherited, colorectal cancer syndrome characterized by the growth of colorectal polyps. Though the polyps are initially benign, they become malignant in nearly all cases in the absence of colectomy, according to the company.
The drug, dubbed CEQ508, is designed to inhibit the oncogene beta-catenin, which is expected to prevent new polyp formation and possibly slow the progression to malignancy of existing ones.
The company said it is now working with the clinical center where a proposed phase I trial of the drug is to be run, the Fred Hutchinson Cancer Research Center in Seattle, to obtain the necessary institutional approvals. The study is slated to begin in early 2010.
Cequent first filed the IND in November (see RNAi News, 11/19/2009).