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Marina Biotech Announces Clinical Protocol Approval of CEQ508 at Massachusetts General Hospital


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Marina Biotech, Inc., a leading RNAi-based drug discovery and development company, today announced institutional site approval at Massachusetts General Hospital (MGH), for their clinical trial protocol for Familial Adenomatous Polyposis (FAP), allowing trial initiation including patient enrollment and dosing. The protocol was independently reviewed and approved by the Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC) at MGH, a world class medical center and clinical trial site. The trial, consisting of two phases, is designed to determine safety and tolerability of CEQ508, which is both the company's first RNAi-based therapeutic to reach human clinical trials and the first orally administered RNAi-based therapeutic to reach human clinical trials. In addition, the company announced the trial's Principal Investigator and the formation of a Data Safety Monitoring Board (DSMB) responsible for overall safety decisions in addition to reviewing data between phases.

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

"CEQ508 utilizes our orally administered, transkingdom RNAi technology which provides an extremely efficient and convenient approach to delivery of an RNAi-based therapeutic. We are also pleased to announce a world-class team of clinical investigators who will form our DSMB. With the pending dosing of CEQ508 in patients with FAP, we become one of the few RNAi companies with programs in clinical development."

The CEQ508 trial will be conducted under the guidance of Daniel C. Chung, M.D., Clinical Chief, Gastrointestinal Unit and Director, High Risk GI Cancer Clinic at MGH who will serve as the trial's Principal Investigator. Marina Biotech's Data Safety Monitoring Board (DSMB) is comprised of accomplished scientific and medical leaders of the gastrointestinal community and will function as the safety review committee throughout both phases of the trial. Committee members include Anil K. Rustgi, M.D., T. Grier Miller Professor of Medicine and Chief, Division of Gastroenterology at the University of Pennsylvania; Fay Kastrinos, M.D., M.P.H., Assistant Professor of Medicine and Director, Familial Colon Cancer Clinic at Columbia University Medical Center; and Kenneth Hung, M.D., Ph.D., Assistant Professor of Medicine at Tufts Medical Center.

CEQ508 is the first drug candidate in a novel class of therapeutic agents utilizing the transkingdom RNA interference (tkRNAi) platform. CEQ508 comprises attenuated bacteria that are engineered to enter into dysplastic tissue and release a payload of short-hairpin RNA (shRNA), a mediator in the RNAi pathway. The shRNA targets the mRNA of beta-catenin, which is known to be dysregulated in classical FAP. CEQ508 is being developed as an orally administered treatment to reduce the levels of beta-catenin protein in the epithelial cells of the small and large intestine. Upon enrollment, patients will be placed in one of four dose-escalating cohorts. Following completion of the dose escalation phase, the trial plan calls for a stable-dose phase in which additional patients will receive the highest safe dose. CEQ508 will be administered daily in an oral suspension for 28 consecutive days

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