September 16, 2008
Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) Awards Cleveland BioLabs Contract to Develop Protectan CBLB502
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) has awarded the Company a 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. The total contract value including all milestone-based options is $13.3 million over a three-year period, with the first year's award of $3.4 million, commencing September 16, 2008.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, stated, "We are excited to receive this award from a major potential buyer of radiation countermeasures. We believe it strengthens Protectan CBLB502's position as a leading candidate for acquisition for the Strategic National Stockpile, upon FDA approval. Protectan CBLB502's unprecedented efficacy, unique ability to address both hematopoietic and gastrointestinal damage, broad time window of use, and mitigation effects that do not require additional supportive care set it apart from any other existing or potential therapies. This award, together with the $8.9 million contract we received earlier in the year from the Department of Defense, is expected to support the final stages of Protectan CBLB502's development necessary for submission for FDA approval and demonstrates clear and strong support of our product development by two major potential customers."
Cleveland BioLabs has successfully established cGMP quality manufacturing for Protectan CBLB502, demonstrated preclinical efficacy and safety of this product and recently received an allowance from the FDA to begin Phase I clinical trials in human volunteers. Protectan CBLB502 is being developed under the FDA's animal efficacy rule to treat radiation injury following exposure to radiation from nuclear or radiological weapons, or from nuclear accident. This approval pathway requires demonstration of efficacy in two animal species and safety and drug metabolism testing in a representative sample of healthy human volunteers.
Protectan CBLB502 is a derivative of a microbial protein that mitigates injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
Development of Protectan CBLB502 has been supported by grants from the Department of Health and Human Services and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health through the Project BioShield Act of 2004, as well as by the National Aeronautics and Space Administration and the Defense Threat Reduction Agency and Chemical Biological Medical Systems of the Department of Defense.
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: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: [email protected]
SOURCE: Cleveland BioLabs, Inc.