Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) Awards Cleveland BioLabs Contract to Develop Protectan CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - September 16, 2008) - 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.