Marina Biotech Announces First Patient Enrollment in FAP Clinical Trial
Product News Mar 15, 2011
Marina Biotech, Inc. has announced enrollment of the first patient in the Dose Escalating Phase of its Phase Ib/IIa clinical trial, Safety and Tolerability of An RNAi Therapeutic in FAP or START-FAP, with CEQ508 intended for the treatment of Familial Adenomatous Polyposis (FAP).
CEQ508 is the first ever orally administered RNAi-based therapeutic to reach human clinical development and recently received orphan drug designation from the Food and Drug Administration (FDA).
The Dose Escalating Phase of the START-FAP trial involves an oral regimen, administered daily for 28 days. The trial is being conducted at Massachusetts General Hospital in adult patients with FAP. Enrollment involves a thorough screening process, including an in-depth assessment and assurance that the patient meets the study inclusion criteria, and occurs between 7 and 30 days prior to drug dosing.
In addition, the patient must undergo endoscopy procedures one to seven days prior to the initiation of drug dosing. Following the course of drug administration, a second round of endoscopy procedures will be performed. Biopsies taken at baseline and end-of-treatment time points will allow safety evaluations as well as analysis of biomarker changes.
"We're pleased to announce patient enrollment - a first step, in what we hope will be a rapid regulatory and clinical timeline to the commercialization of CEQ508 for the treatment of patients with FAP," said J. Michael French, President and CEO of Marina Biotech.
French continued, "Patients participating in the START-FAP trial will make a significant commitment throughout the trial period as each patient will undergo extensive pre- and post-dosing regimen procedures as well as daily visits by a home nurse to administer the CEQ508 dose. We commend and appreciate every patient participating in this trial as their dedication lays a critical framework upon which we can quickly advance to a pivotal trial and bring a much needed therapeutic option to patients in need."