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Marina Biotech's CEQ508 Granted FDA Fast Track Designation for Familial Adenomatous Polyposis
Marina Biotech's CEQ508 Granted FDA Fast Track Designation for Familial Adenomatous Polyposis.
About this update from Adhera Therapeutics Inc.
[{"type":"text","content":"\n \n \n Marina Biotech's CEQ508 Granted FDA Fast Track Designation for Familial Adenomatous Polyposis\n \n \nMarina Biotech's CEQ508 Granted FDA Fast Track Designation for Familial Adenomatous Polyposis\n\nCompany Also Receives U.S. Patent Allowance Broadly Covering tkRNAi Bacterial Compositions\n\n \n BOTHELL, WA--(Marketwired - Aug 5, 2015) - Marina Biotech, Inc. (OTCQB: MRNA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CEQ508, an investigational RNAi therapeutic for the treatment of Familial Adenomatous Polyposis (FAP). Currently, there is no pharmaceutical approach available to treat FAP, which affects an estimated one in 10,000 people worldwide and is associated with a near 100% risk of colon cancer if untreated. In addition, the company announced the allowance of US 13/196,436 covering the tkRNAi delivery technology -- the delivery technology for CEQ508 -- in the U.S. The patent broadly covers a wide range of vectors for bacterial mediated gene silencing, as well as the fundamental invasive bacterium for delivering RNA therapeutics. \n Fast Track is a process designed by the FDA to facilitate the development, and expedite the review of new drugs to treat serious conditions and fill an unmet medical need. Fast Track designated drugs are eligible for more frequent communication with the FDA and may receive Accelerated Approval and Priority Review. \n \"We believe that Fast Track designation, together with Orphan Drug status previously granted by the FDA for CEQ508, provides Marina a unique opportunity to address an unmet medical need and bring CEQ508 to patients with Familial Adenomatous Polyposis as quickly as possible,\" said Michael French, president and Chief Executive Officer. \"The Fast Track designation for CEQ508 can significantly reduce the review time of a new drug application and therefore reduce the time to market. In addition, the recent U.S. patent allowance for the tkRNAi delivery technology expands the broad international coverage of this technology, which now includes related patents granted in Europe, Japan, Korea, Australia and Canada. Fast Track designation for CEQ508 and the further expansion of the intellectual property estate surrounding the tkRNAi platform continues to build the value of our pipeline and, in particular, our lead clinical prog...