Marina Biotech Announces Interim Safety Results of Long-Term Toxicology Study

CEQ508 was administered in an oral suspension once daily to non-human primates for over 180 consecutive days at a dose level of 10(11) colony forming units (cfu)/day. During this period of time, no toxicity or test article related adverse events were observed. To support the potential requirements of a Phase 2 clinical trial, the non-human primate study was extended for an additional three months. CEQ508 is Marina Biotech's clinical candidate for the treatment of Familial Adenomatous Polyposis (FAP), and is expected to begin dosing in patients in a Phase 1b/2a trial this quarter.

"These interim results and the completion of the full nine month safety study in non-human primates demonstrates the potential for the long term treatment of patients with our novel RNAi-based therapeutic," said J. Michael French, President & CEO of Marina Biotech. "CEQ508 is Marina Biotech's first drug candidate to reach human clinical trials. We're very excited to begin the clinical trial and look forward to quickly advancing this drug to the market and providing a necessary therapeutic to a patient population in need."

CEQ508 is the first drug candidate in a novel class of therapeutic agents utilizing the transkingdom RNA interference (tkRNAi) platform. CEQ508 is comprised of 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 β-catenin, which is known to be dysregulated in classical FAP. CEQ508 is being developed as an orally administered treatment to reduce the levels of β-catenin protein in the epithelial cells of the small and large intestine. The Phase 1b/2a clinical trial will be conducted in patients with FAP at Massachusetts General Hospital, Boston, Massachusetts.