BUFFALO, NY -- (Marketwire) -- 05/28/09 -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it has responded to the Sources Sought Notice issued on May 5, 2009 by the Department of Defense (DoD) to identify interested companies that have the capability to develop and manufacture specifically identified Chemical, Radiological and Nuclear (CRN) therapeutics.

According to the Sources Sought Notice, the Chemical Biological Medical Systems Medical Identification and Treatment Systems Joint Product Management Office (CBMS-MITS JPMO) of the DoD is seeking identification of sources having the capability to develop, through FDA approval and production, the following CRN therapeutics:

  • An aerosolized atropine drug delivery system to treat lingering effects of nerve agent intoxication related to muscarinic stimulation;
  • A radiological/nuclear therapeutic medical countermeasure to be administered following exposure to ionizing radiation that will decrease incapacity and prolong survival by treating the gastrointestinal sub-syndrome of Acute Radiation Syndrome (ARS);
  • Amyl nitrate as an adjunct to current military cyanide treatment regimen.

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, "We view this Sources Sought Notice as further demonstration of the DoD's commitment to procuring the best possible available medical countermeasures against a broad spectrum of CRN threats. We believe CBLI has a very successful working relationship with the CBMS-MITS JPMO, as they are currently providing assistance on discreet and limited elements associated with the advanced development of our lead radiation protection compound, Protectan CBLB502, in conjunction with other federal agencies."

Cleveland BioLabs' Protectan CBLB502 has demonstrated statistically significant increases in survival and mitigation of both gastrointestinal and hematopoietic radiation-induced damage in rodent and non-human primate models of ARS. The protective effects of CBLB502 were observed in primates when administered as late as 72 hours after irradiation.

Protectan CBLB502 is being developed under the FDA's animal efficacy rule to treat radiation injury following exposure to radiation from nuclear or radiological weapons, or from nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety and drug metabolism testing in a representative sample of healthy human volunteers. Cleveland BioLabs is currently concluding the first of two human safety studies in healthy volunteers.

Cleveland BioLabs received, under a Broad Agency Announcement, a contract valued at up to $8.9 million from the CBMS-MITS JPMO of the DoD in April 2008 providing assistance on discreet and limited elements associated with the advanced development of the Company's lead radiation protection compound, Protectan CBLB502. Cleveland BioLabs also received a contract valued at up to $13.3 million from the Biomedical Advanced Research and Development Authority of the of the Department of Health and Human Services in September 2008 for certain elements related to the advanced development of Protectan CBLB502.

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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2009.

Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com