SOURCE: Cleveland BioLabs, Inc.

September 24, 2009 09:55 ET

Cleveland BioLabs Receives $2.3 Million Addition to $13.3 Million Contract With Biomedical Advanced Research and Development Authority (BARDA) to Develop Radiation Countermeasure Protectan CBLB502

BUFFALO, NY--(Marketwire - September 24, 2009) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the first milestone-based option on the Company's existing contract under the Broad Agency Announcement titled, "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation," for selected tasks in the advanced development of Protectan CBLB502. In addition, BARDA increased the first milestone-based option from $4.0 million to $6.3 million, increasing the total contract value including all milestone-based options from $13.3 million to $15.6 million over the three-year period.

The funds under this option will be used to support clinical studies, toxicology and manufacturing necessary for completion of a Biologic License Application (BLA) for the U.S. Food and Drug Administration (FDA).

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, "BARDA's decision to both exercise and increase this milestone-based funding option under our development contract is a strong indication of the progress we have made in advancing Protectan CBLB502 towards submission for FDA licensure. We look forward to continuing our collaborative efforts."

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