Marina Biotech, Inc., has announced the initiation of patient dosing in the Dose Escalation Phase of its START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial with CEQ508.
Marina Biotech's Phase 1b/2a trial is an open-label, escalating-dose study of single daily doses of CEQ508 and will be conducted as a single center study in Boston, Massachusetts.
The first cohort comprised of three patients will be administered the starting dose of 1x10(8) colony forming units (cfu)/day. The study is primarily designed to evaluate the safety and tolerability of CEQ508 in patients with Familial Adenomatous Polyposis (FAP) after 28 days of daily, oral dosing.
The trial is also intended to provide data on beta-catenin biomarker changes pre- and post-treatment and pharmacokinetic data related to the gastrointestinal coverage of CEQ508. The Dose Escalation Phase consists of 12 patients in four dose escalating cohorts; two patients in the first dosing group have been enrolled.
"We're very pleased to be able to announce the initiation of patient dosing in our START-FAP trial," stated J. Michael French, President and CEO at Marina Biotech.
French continued, "The trial will allow us to establish the most appropriate once-daily dose for further clinical development, and will augment our existing safety database for CEQ508. In combination with the recently completed long-term non-human primate safety study and the orphan drug designation granted late last year, we remain on a rapid clinical development timeline for commercialization of CEQ508. We believe CEQ508 has the potential to be a safe and efficacious therapeutic for a patient population with no currently approved pharmaceutical alternative."