Biomedical Advanced Research and Development Authority (BARDA) Exercises $4.1 Million Fourth Option on Cleveland Biolabs Inc. Contract to Develop Radiation Countermeasure CBLB502

BUFFALO, NY--(Marketwire - July 29, 2010) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the $4.1 million fourth milestone-based option on the Company’s existing contract under the Broad Agency Announcement titled, “Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation,” for selected tasks in the advanced development of Protectan CBLB502. The value of the contract, originally awarded in September 2008, is $15.6 million, including an increase in the first milestone-based option, which was exercised in September 2009.

Option four supports validation of the CBLB502 manufacturing process, manufacturing of three additional registration batches of the drug, and additional animal studies. All of these activities are necessary for completion of a Biologic License Application (BLA) for the U.S. Food and Drug Administration (FDA).

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, “We are pleased that our efforts to advance CBLB502 towards submission for FDA licensure have resulted in BARDA’s decision to execute the fourth option under our current contract.”

The Company recently announced that CBLB502 was granted Fast Track status from the FDA for reducing the risk of death following total body irradiation during or after a radiation disaster.

About CBLB502
CBLB502 is a derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

CBLB502 is being developed by Cleveland BioLabs under the FDA’s Animal Efficacy Rule to treat 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, pharmacokinetic, pharmacodynamic and biomarker 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 human 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. Dosing of 100 subjects in a second human safety study for CBLB502 was completed in May. Analysis of safety and biomarker data from this study is ongoing. There is currently no FDA approved medical countermeasure to reduce the risk of death following total body irradiation.

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company’s website at http://www.cbiolabs.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s periodic filings with the Securities and Exchange Commission.