SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

September 22, 2009 08:30 ET

National Institute of Allergy and Infectious Diseases Awards Cleveland BioLabs Additional Grant for Protectan CBLB502 Research in Mitigation of Radiation Damage

BUFFALO, NY--(Marketwire - September 22, 2009) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it has been awarded an additional $458,512 grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), to continue studies of certain mitigating properties of Protectan CBLB502 in the context of hematopoietic (blood/bone marrow) damage from radiation exposure. The Company had previously received $774,183 under this grant, Medical Countermeasures to Enhance Platelet Regeneration and Increase Survival Following Radiation Exposure, which is funded through the Project BioShield Act of 2004 and administered by the Department of Health and Human Services.

The goal of this program is to accelerate the development of safe and effective medical products to mitigate and treat thrombocytopenia and to enhance platelet regeneration after radiation exposure from radiological and nuclear terrorist attacks. Specifically, this initiative supports research and development of promising new approaches and medical products to enhance platelet regeneration and yield improved survival. Currently, there is no approved therapeutic drug in the Strategic National Stockpile for this radiation-induced complication.

"With NIAID's support, we have successfully demonstrated Protectan CBLB502's strong ability to mitigate the occurrence and severity of thrombocytopenia, as well as to accelerate recovery time in non-human primate models. We believe that the allocation of additional funds for this work is indicative of NIAID's recognition of our progress in developing Protectan CBLB502 as a potential medical countermeasure," commented Andrei Gudkov, Ph.D., D. Sci., Cleveland BioLabs Chief Scientific Officer and Principle Investigator on the grant. "This funding will help accelerate our work towards optimizing potential regimens of administration for enhanced mitigation of radiation-induced thrombocytopenia, a major determinant of the severity of acute radiation syndrome and mortality."

About CBLB502

CBLB502 is a derivative of a microbial protein, which has demonstrated the capacity to reduce injury from acute stresses, such as radiation and chemotherapy, in animal models. CBLB502 mobilizes several tissue protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.

CBLB502 is being developed under the U.S. Food and Drug Administration's Animal Efficacy Rule to treat Acute Radiation Syndrome (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 and drug metabolism 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 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. As part of the development of CBLB502, this study will be followed by a second, larger safety study in healthy human volunteers, which will be based on the results of the initial study. There is currently no FDA approved medical countermeasure to treat ARS.

CBLB502 is also being developed as a supportive care measure to reduce and prevent occurrence of side effects of radiotherapy or chemotherapy in cancer treatment.

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.

Contact Information

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