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BUFFALO, N.Y., Oct. 1, 2012 (GLOBE NEWSWIRE) --
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the receipt of the End-of-Phase II meeting minutes (the "Minutes") and an Advice Letter providing further clarification on the remaining clinical study protocols for the development of Entolimod™ (CBLB502) as a radiation countermeasure from the U.S. Food and Drug Administration (the "FDA").
The Minutes reiterated the FDA's commitment to moving the Entolimod™ program forward and summarized the Agency's responses and requests regarding several aspects of the Company's proposed plan for dose conversion, as discussed during the meeting and in related correspondence.
The Advice Letter provided specific guidance on the structure of the remaining clinical studies, including two primary study outcomes: generation of additional biomarker information for dose conversion as an initial study focus and then subsequent generation of extended safety data using the projected efficacious dose defined by the initial dose conversion study. The letter also provided specific recommendations on several technical aspects of the Company's proposed clinical protocol that remain in active and ongoing discussion.
Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, stated, "This correspondence represents a significant step forward in delineating the path forward for Entolimod™ and we continue to be pleased by our interactions with the FDA. We believe that the receipt of the Minutes and feedback on our clinical program, along with our previously announced agreements on the pivotal animal program enable us to continue funding discussions with our government agency partners."
The Company previously announced the receipt of an Advice Letter from the FDA indicating agreement with the design of the proposed pivotal animal efficacy studies and accepting the Company's recently concluded Good Laboratory Practice non-human primate study as part of the pivotal program.
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.