Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced development, Food and Drug Administration (FDA) approval/licensure and delivery of Medical Radiation Countermeasure (MRC).

In a statement to the press, Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, commented that the DoD's RFP described a countermeasure as one that would be administered following exposure to ionizing radiation that will decrease incapacity and prolong survival by treating the gastrointestinal sub-syndrome of ARS. "We believe our radiation protection drug candidate, CBLB502, fits these and other listed criteria," noted Fonstein.

Dr. Fonstein reviewed CBLB502's development and highlighted the more than $32 million in development funding received over the past two years from several federal agencies, including the DoD, the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

"The tremendous programmatic and funding support from these US government agencies is instrumental in the successful development of CBLB502 working towards FDA licensure," said Fonstein. "CBLI views this support as a partnership to ensure that both the DoD and, potentially the HHS, have a capability to protect individuals against the terrorist threat of a radiation event."

Andrei Gudkov, Ph.D., D. Sci., Chief Scientific Officer for Cleveland BioLabs and Senior Vice President of Basic Research at Roswell Park Cancer Institute, also shared some background on CBLB502 and its properties.

About CBLB502

CBLB502 is a derivative of a microbial protein, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation in animal models. CBLB502 mobilizes several cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

CBLB502 is being developed under the U.S. Food and Drug Administration's Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon/ dirty bomb, or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety and pharmacodynamic drug marker testing in healthy human volunteers.

Evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 50 subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. There is currently no FDA approved medical countermeasure to treat ARS.

Source
Cleveland BioLabs, Inc.