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FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
Date:12/10/2009

CAMBRIDGE, Mass., Dec. 10 /PRNewswire/ -- Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) approved Cequent's first IND (investigational new drug) application yesterday. This action enables Cequent to initiate the first-ever trial of an orally administered RNA interference drug in humans: CEQ508 - the company's lead drug candidate based on its proprietary tkRNAi technology. CEQ508 targets beta-catenin, a key oncogene implicated in the formation of colonic polyps and in the progression of polyps to colorectal cancer.

The IND application acceptance is the second procedural hurdle that the young company has cleared in order to begin human clinical trials of CEQ508 in the FAP (familial adenomatous polyposis) patient population. The company noted that the 14 reviewing members of the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) voted unanimously to endorse the proposed clinical protocol after conducting an in-depth review and public discussion of the proposed CEQ508 program on September 9, 2009.*

"We submitted our IND application to the FDA on November 9, 2009. Having our first IND application accepted in the 30-day period is an extraordinary accomplishment for any company, particularly so for Cequent, given that we are working on an entirely new class of drugs," said Cequent Chief Executive Officer Peter Parker. "It speaks volumes to the quality of the submission, which comprised more than 4,000 pages. I'm so proud of our scientific team, who, in a short time, were successful in turning an intriguing RNAi research concept into a viable drug candidate ready to be tested in humans."

The FDA approved Cequent's proposed clinical protocol for the Phase I clinical trial, including
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SOURCE Cequent Pharmaceuticals, Inc.
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