Marina Biotech, Inc., has announced that it has completed a 9 month toxicology study in non-human primates with its first drug candidate, CEQ508. CEQ508 is currently in a Phase 1b/2a clinical development program and is intended for the treatment of Familial Adenomatous Polyposis. During the study, 18 cynomolgus monkeys were administered daily oral doses of either CEQ508 or control article for 281 days.
No test article-related adverse responses were identified in the following parameters: clinical observations, body weights and temperatures, serum chemistry, coagulation, hematology, urinalysis, cytokines and gross pathology.
Additionally, monthly biopsies of colonic mucosa showed no evidence of local immune activation. CEQ508 was recently granted Orphan Drug Designation by the FDA's Office of Orphan Products Development.
"In preparation for an anticipated Phase 2 clinical trial, we initiated the enabling toxicology work early and are pleased to announce the recent completion of this program," stated Barry Polisky, Ph.D., Chief Scientific Officer at Marina Biotech, Inc.
"Preliminary conclusions identify the No Observed Adverse Effect Level (NOAEL) for long-term daily oral administration of CEQ508 as 1x10(11) colony forming units (cfu)/day. This was the highest dose administered to these animals. We are encouraged by these results which provide important safety data for chronic administration of CEQ508."