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BUFFALO, N.Y., Sept. 10, 2012 (GLOBE NEWSWIRE) --
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the receipt of an Advice Letter from the U.S. Food and Drug Administration (FDA) indicating agreement with proposed pivotal animal efficacy studies for the development of CBLB502 (Entolimod™) as a radiation countermeasure. The FDA also accepted the Company's recently concluded Good Laboratory Practice non-human primate (NHP) study as part of the pivotal program.
Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance for Cleveland BioLabs, stated, "We are encouraged by the multiple agreements outlined in the FDA's correspondence, as well as the prompt nature of their response. We are pleased with both our progress and the constructive nature of our recent interactions, and look forward to receipt of the August End-of-Phase II meeting minutes along with additional feedback on our clinical protocol."
Entolimod™ is a therapeutic drug currently in development under the FDA's Animal Rule to reduce the risk of death after total body irradiation. The Animal Rule provides a mechanism for marketing approval when human efficacy studies are not ethical or feasible. Development under the Animal Rule includes efficacy studies in animal models and human safety studies, as well as studies to support the conversion of the effective dose in animals to an effective dose in humans.
In June, the Company announced survival results for its randomized, blinded, placebo-controlled efficacy study of Entolimod™ in 179 NHPs conducted under Good Laboratory Practice with elements of Good Clinical Practice, as required by the Animal Rule. This study demonstrated with a high degree of statistical significance that a single dose of Entolimod™ given to Rhesus macaques 25 hours after exposure to a 70% lethal dose of total body irradiation improved animal survival by nearly three times compared to the control group. Dose-dependence of Entolimod's™ efficacy was demonstrated with doses above the minimal efficacious dose establishing a plateau at approximately 75% survival at 60 days after irradiation, as compared to 27.5% survival in the placebo-treated group.