Cleveland BioLabs Protectan CBLB502 Demonstrates Strong Mitigation Of Hematopoietic Damage At 48 Hours Post-Exposure To 6.5 Gy Of Radiation

Main Category: Radiology / Nuclear Medicine
Article Date: 01 Apr 2008 - 1:00 PDT

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Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that recent primate studies have demonstrated the efficacy of Cleveland BioLabs's Protectan CBLB502 as a mitigator of hematopoietic damage up to 48 hours post radiation exposure.

Protectan CBLB502 was administered as a single injection at 48 hours post-exposure to 6.5 Gy doses of ionizing radiation, which results in approximately 75% mortality, if untreated (similar to doses received by Chernobyl firefighters). In the non-human primate model tested, approximately 67% of the Protectan CBLB502-treated animals survived compared to 25% of the control group. Administration of CBLB502 48 hours post exposure was shown to increase survival, and have a significantly beneficial effect on platelet levels while also reducing the severity of radiation-induced neutropenia.

Protection of civilian populations and war-fighters is of high current interest to both the Department of Health and Human Services (HHS) and the Department of Defense (DoD). On March 6, 2008 the Biomedical Advanced Research and Development Authority (BARDA), a Department of HHS, published a Broad Agency Announcement (BAA) soliciting research and development proposals for "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation."

BARDA seeks to acquire developed medical countermeasures that will be clinically useful in a civilian medical emergency situation that results from or involves exposure of a large population to the effects of a nuclear detonation, a radiologic dispersive device (such as a dirty bomb), or exposure to radioactive material with or without combined injury or trauma. Among certain other criteria, the BAA specified that any medical countermeasures submitted must be efficacious when administered at or later than 24 hours after exposure.

The BAA anticipates the award of 5 to 6 three-year contracts, each valued at $3 to $5 million annually, to be made on or about September 16, 2008. The BARDA BAA may be accessed from the following URL.

Cleveland BioLabs's Protectan CBLB502 has the ability to replenish normal hematopoietic profile in non-human primates, as demonstrated by recent experiments. CBLB502 is a derivative of a microbial protein that reduces injury from acute stresses by mobilizing several natural cell protecting mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration promoting cytokines. Potential medical applications for CBLB502 include reduction of radiotherapy or chemotherapy side effects in cancer patients.

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, 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.

Cleveland BioLabs

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