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Marina Gets Institutional Approval to Begin Phase I Study of FAP Drug

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Marina Biotech said this week that it has received institutional site approval at Massachusetts General Hospital for its investigational familial adenomatous polyposis treatment CEQ508, clearing the way for initiation of a planned phase I study of the drug.

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.

CEQ508 is based on Cequent Pharmaceuticals' so-called transkingdom RNAi technology, and 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.

Marina acquired Cequent earlier this year.

"Clinical site approval at MGH marks the last regulatory requirement prior to moving our first drug candidate into human trials," Michael French, president and CEO of Marina, said in a statement.

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