SOURCE: Cleveland BioLabs, Inc.

July 17, 2007 08:58 ET

Cleveland BioLabs Submits Responses to Two Requests for Information From Department of Health and Human Services and National Institute of Allergy and Infectious Diseases

Addresses Requests for Medical Countermeasures for Neutropenia and Thrombocytopenia Arising From Acute Radiation Syndrome

BUFFALO, NY--(Marketwire - July 17, 2007) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) (BOST: CFB) today announced that it has submitted responses to two Requests for Information (RFI) from the Department of Health and Human Services (HHS) and National Institute of Allergy and Infectious Diseases (NIAID) addressing medical countermeasures for neutropenia (low levels of neutrophils, a type of white blood cell) and thrombocytopenia (low platelet count) arising from Acute Radiation Syndrome (ARS).

Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs stated, "We are pleased to support the Government's efforts to establish countermeasures against potential radiation threats. Our Protectan family of compounds has demonstrated strong effects against both neutropenia and thrombocytopenia resulting from ARS, as well as overall survival benefits."

ARS, also referred to as radiation sickness, is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a relatively short time period. Such exposure can result in the depletion of hematopoietic (bone marrow/blood production) stem cells and progenitors, leading to severe neutropenia and thrombocytopenia. Severe neutropenia increases the risk of sepsis and death due to opportunistic infections, while thrombocytopenia increases the risk of hemorrhage and death due to bleeding. Both conditions are likely to be major contributors to mortality in untreated individuals exposed to doses of radiation that affect the hematopoietic system.

The RFI from HHS noted the agency's intention to pursue initial acquisition of 100,000 treatment courses of a medical countermeasure for neutropenia arising as a consequence of ARS. The RFI further stated that there would be options for up to an additional 100,000 treatment courses to meet the US Government's requirement of at least 200,000 treatment courses. The HHS RFI stated that a Request for Proposal (RFP) would be announced in August 2007, with proposals due in November 2007.

Cleveland BioLabs submitted its Protectan CBLB502 for the HHS RFI. Protectan CBLB502 has proven effective 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.

Earlier this year, Cleveland BioLabs submitted Protectan CBLB502 to the Department of Defense (DoD) in response to a RFP for medical radiation countermeasures to treat gastrointestinal effects of ARS. The DOD RFP award would provide funding for development of the countermeasure through FDA approval, as well as a commitment to purchase up to 500,000 doses, thereafter. The Company has stated that it expects the DoD RFP to be awarded in late 2007.

The RFI from NIAID requested the identification of therapeutics likely to be effective in preventing or reducing the development of thrombocytopenia, when administered after acute exposure to radiation. The NIAID RFI was distributed on behalf of the National Institutes of Health (NIH) and indicated that data obtained from this RFI would be used by the NIH in making recommendations and decisions regarding research and development of radiation countermeasures to meet the nation's biodefense needs.

Cleveland BioLabs submitted its Protectan CBLB612 for the NIAID RFI. CBLB612 has established both radiation protection and mitigation properties over a very broad time window of use. In animal experiments, Protectan CBLB612 has produced complete and sustained recovery of the hematopoietic system following lethal doses of radiation. Recent primate studies have shown a single administration of CBLB612 to cause a 20-fold increase of hematopoietic progenitor cells in peripheral blood.

The National Institute of Allergy and Infectious Diseases (NIAID) RFI may be accessed from the following URL: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-07-033.html

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 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. 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.

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