Marina Biotech Completes Dosing of First Cohort in the Phase 1b/2a START-FAP Clinical Trial of CEQ508
Marina Biotech, Inc. has announced the completion of dosing for Cohort 1 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 first three patients received the starting dose of 1x10(8) 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 2 is expected to begin in July 2011 with each patient in the cohort receiving a dose of 1x10(9) cfu/day for up to 28 days.
"We're pleased to announce the completion of dosing of the first patient Cohort and plan to progress to Cohort 2 of our START-FAP trial," stated J. Michael French, President and CEO at Marina Biotech.
French continued, "This first dose will serve as the initial foundation for establishing a comprehensive safety profile for oral administration of CEQ508. Progression through the dose escalation phase will determine the most appropriate once-daily dose for future clinical development. 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."