CLEVELAND, April 23 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. (NASDAQ:CBLI)(BostonStockExchange:CFB), today announced that it has responded to the Request for Proposal (RFP) issued in March 2007, by The Department of Defense (DoD) for the Advanced Development of Medical Radiation Countermeasures (MRC) to treat gastrointestinal effects of acute radiation syndrome (ARS). It is expected that the RFP may be awarded later in the year.

The objective of the RFP is to develop a post-exposure Medical Radiation Countermeasure through approval/licensure with the U.S. Food and Drug Administration (FDA) and procure quantities sufficient to achieve Initial Operational Capability (IOC). A range of 50,000 to 500,000 doses was specified. The RFP award would provide funding for development of the countermeasure through FDA approval, as well as a commitment to purchase, thereafter.

Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs stated, "We believe our Protectan CBLB502 is well-suited to the requirements outlined by the RFP. We are on track to complete current Good Manufacturing Practices (cGMP)-compliant manufacturing by fall 2007 and submit an Investigational New Drug (IND) application for a human safety study later this year. If development continues as expected, we plan to file an application for final approval of CBLB502 with the FDA in mid to late 2008."

Cleveland BioLabs's lead compound, Protectan CBLB502, has demonstrated effectiveness in animal models as a radiation countermeasure when administered up to 24 hours prior to exposure or up to 8 hours after. CBLB502 is the first compound to provide protection from both gastrointestinal and hematopoietic (bone marrow/blood production) radiation-induced damage with no toxicity at therapeutic doses. Protectan CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires the Company to show efficacy in two animal species and only safety in humans.

In March, Cleveland BioLabs received a contract from the Defense Threat Reduction Agency (DTRA) of the Department of Defense (DoD) to fund "development leading to the acquisition" of Protectan CBLB502, in collaboration with the Armed Forces Radiobiology Research Institute (AFRRI), which has also received significant independent funding for work on Protectan CBLB502.

The Department of Defense RFP may be publicly accessed from the following URL:

In related news, the Department of Health and Human Services (HHS) recently released its Public Health Emergency Medical Countermeasure Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats, in which it announced its continued pursuit of the acquisition of medical countermeasure to treat ARS. The plan states that in March 2007, HHS withdrew its ARS RFP because it was determined, after extensive scientific and technical expert evaluation, that no competing offeror had a product that met U.S. government requirements for a Project BioShield acquisition. At the time the HHS RFP was issued, Cleveland BioLabs did not have its data on protection from radiation-induced hematopoietic damage available and was not able to participate; however, the Company has now completed the necessary trials to qualify for a new RFP.

The plan explained that HHS would continue to pursue an initial acquisition of a safe and effective medical countermeasure to treat ARS and in moving forward to meet this goal, HHS will make use of scientific developments that have occurred since the previous RFP closed, as well as new authorities provided by the Pandemic and All-Hazards Preparedness Act that could accelerate the advanced development of promising countermeasures. The plan also noted that HHS expects near-term procurements against this threat to be greater than $100 million.

The initial development of Protectan CBLB502 was supported by grants from the Department of Health and Human Services, through the BioShield Act, and NASA.

The HHS Public Health Emergency Medical Countermeasure Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats may be publicly accessed from the following URL:

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic Foundation, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Research Radiobiology Institute. To learn more about Cleveland BioLabs Inc., please visit the company's website at

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. Our 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 our Registration Statement on Form SB-2/A filed with the Securities and Exchange Commission on September 8, 2006.

    The Global Consulting Group
    Rachel Levine
    T: (646) 284-9439