CEQ508 is currently in a Phase 1b/2a clinical development program and is intended for the treatment of Familial Adenomatous Polyposis.
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.
During the study, 18 cynomolgus monkeys were administered daily oral doses of either CEQ508 or control article for 281 days.
Marina Biotech chief scientific officer Barry Polisky said in preparation for an anticipated Phase 2 clinical trial, they initiated the enabling toxicology work early and are pleased to announce the recent completion of this program.
"Preliminary conclusions identify the No Observed Adverse Effect Level (NOAEL) for long-term daily oral administration of CEQ508 as 1×10(11) colony forming units (cfu)/day," Polisky said.