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Marina Biotech Completes Dosing of Second Cohort in the Phase 1b START-FAP Clinical Trial of CEQ508
Marina Biotech Completes Dosing of Second Cohort in the Phase 1b START-FAP Clinical Trial of CEQ508.
About this update from Adhera Therapeutics Inc.
[{"type":"text","content":"Marina Biotech Completes Dosing of Second Cohort in the Phase 1b START-FAP Clinical Trial of CEQ508Bothell, WA, April 3, 2012 – Marina Biotech, Inc. (OTCQX: MRNA), a leading nucleic acid-based drug discovery and development company, today announced the completion of dosing for Cohort 2 in the Dose Escalation Phase of its START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial with CEQ508. The three patients of Cohort 2 received a dose of 1x10(9) colony forming units (cfu)/day for up to 28 days of continuous oral dosing. Patients were monitored by study staff on a daily basis with the primary study endpoint of determining safety and tolerability of CEQ508 in patients with FAP. Dosing of Cohort 3 is expected to begin later in the second quarter of this year with each patient in the cohort receiving a dose of 1x10(10) cfu/day for up to 28 days.“We’re pleased to announce the completion of dosing of the second patient Cohort and plan to progress to Cohort 3 of our START-FAP trial,” stated J. Michael French, President and CEO at Marina Biotech. “Progression through the dose escalation phase will determine the most appropriate once-daily dose for the stable dose phase. We are eager to advance into our next dosing cohort and continue to be on track with our projections of completing the dose escalation phase by the end of the year. We believe CEQ508 has the potential to be a safe and efficacious therapeutic for a patient population with no currently approved pharmaceutical alternative.” About CEQ508CEQ508 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 phas...