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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

the choice of the adult FAP patient population, selection of cohort size, the dosing regimen, and duration of treatment. The trial is designed to determine safety and tolerability of CEQ508, starting with a dose-escalation phase in which patients will be given one of four escalating concentrations of the drug, contingent upon safety monitoring. This initial part of the clinical trial is expected to take approximately six months. Next, following a safety review, the trial plan calls for a stable-dose phase in which additional patients will receive the highest safe dose. The FDA will permit daily dosing of 18 or more patients for 28 days. A key readout and secondary objective of the trial includes analysis of biomarker beta-catenin expression changes in the gastrointestinal tract of patients determined from biopsy samples obtained prior to taking the drug and at the end of the dosing period.

Cequent's Vice President of Drug Development, Alison Silva, commented, "I want to commend the reviewers at CBER who have been very responsive, providing critical feedback immediately following our submission and throughout the application process. They worked with us so that we could address their questions quickly and effectively to reach a successful conclusion by our action date."

With the FDA approval of Cequent's clinical-trial protocol now in hand, the company has begun working with the proposed clinical center to obtain the necessary institutional approvals. Cequent expects to begin the Phase I clinical trial during the first quarter of 2010 at the Fred Hutchinson Cancer Research Center in Seattle, Washington, part of the Fred Hutchinson/University of Washington Cancer Consortium. The Cancer Consortium maintains a registry of FAP patients and is also one of 40 National Cancer Institute-designated comprehensive cancer centers nationwide. Gideon Steinbach, M.D., Ph.D., is slated to be the principal investigator (PI) of the Cequent trial. Dr. Steinbach is
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SOURCE Cequent Pharmaceuticals, Inc.
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