Marina Biotech this week said that a nine-month non-human primate toxicology study of its familial adenomatous polyposis treatment CEQ508 has shown the drug to be safe after repeated administration.
In the study, 18 cynomolgus monkeys received daily oral doses of either CEQ508 or a control agent for 281 days. No drug-related adverse responses were found in regards to clinical observation, body weights and temperatures, serum chemistry, coagulation, hematology, urinalysis, cytokines, or gross pathology, Marina said.
Monthly biopsies of colonic mucosa showed no evidence of local immune activation, the company added.
A company official said that Marina aims to present the data at upcoming oncology conferences.
FAP is an inherited, colorectal cancer syndrome characterized by the growth of colorectal polyps. Though the polyps are initially benign, they become malignant in nearly all cases in the absence of colectomy, according to Marina. CEQ508 is designed to inhibit the oncogene beta-catenin, thereby preventing new polyp formation and possibly slow the progression to malignancy of existing ones. It is currently being tested in the first portion of a phase Ib/IIa study.