SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

October 06, 2009 08:30 ET

Department of Defense Increases Ongoing Contract With Cleveland BioLabs for Developmental Studies Related to Protectan CBLB502

BUFFALO, NY--(Marketwire - October 6, 2009) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Chemical Biological Medical Systems Medical Identification and Treatment Systems Joint Program Executive Office (CBMS-MITS JPEO) of The Department of Defense (DoD) increased the Company's ongoing contract, awarded in April 2008 for developmental studies related to Protectan CBLB502, from $8.86 million to $9.59 million. The additional funds are intended to support bridging studies.

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, "We are gratified by the continued support demonstrated by the CBMS-MITS JPEO."

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 by Cleveland BioLabs 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 its development of CBLB502, Cleveland BioLabs will be conducting 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2009.

Contact Information

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