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