Marina Biotech, Inc. has announced that Cohort 2 in the Dose Escalation Phase of the START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial with CEQ508 will begin enrolling patients in the next several weeks at Massachusetts General Hospital (MGH) in Boston.
The Company also noted that it has successfully transferred all GMP-related stability testing to a contract services organization.
"Three patients completed Cohort 1 of the study last year," stated Alan W. Dunton, M.D., Consulting Chief Medical Officer at Marina Biotech.
Dunton continued, "CEQ508 was well tolerated by patients with FAP and the Data Review Committee, comprised of the Principal Investigator, Co-Investigator and myself, unanimously agreed that the study should proceed to Cohort 2. CEQ508 has the potential to be a safe and efficacious therapeutic for a patient population with no currently approved pharmaceutical alternative."
"We are encouraged by the positive safety results from the first cohort and the advancement this represents for CEQ508 and the tkRNAi platform overall," stated Richard Ho M.D.-Ph.D., Executive Vice President, Research and Development at Marina Biotech.
Ho continued, "The oral delivery of CEQ508, a highly potent oligonucleotide therapeutic, is unique in the RNAi and nucleic acid space. As proper for a Phase I study and a first-in-class therapeutic, the Cohort 1 dose level is below that expected to result in robust inhibition of beta-catenin messenger RNA, the gene target for CEQ508. However, data collected for Cohort 1 indicates the potential for exposure of CEQ508 throughout the entire intestinal tract which is important for not only FAP but any disease that involves the gastrointestinal system. We look forward to collecting additional safety data in Cohort 2."