Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Submits Response to Department of Defense Request for Proposal for Radiation Countermeasure
Hosts Press Conference to Discuss Business and Clinical Updates
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - February 24, 2010) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that it has submitted a response to the Request for Proposal
(RFP) issued by The Department of Defense (DoD) for the advanced
development, Food and Drug Administration (FDA) approval/licensure and
delivery of Medical Radiation Countermeasure (MRC).
In a statement to the press, Michael Fonstein, Ph.D., Chief Executive
Officer and President of Cleveland BioLabs, commented that the DoD's RFP
described a countermeasure as one that would be administered following
exposure to ionizing radiation that will decrease incapacity and prolong
survival by treating the gastrointestinal sub-syndrome of ARS. "We believe
our radiation protection drug candidate, CBLB502, fits these and other
listed criteria," noted Fonstein.
Dr. Fonstein reviewed CBLB502's development and highlighted the more than
$32 million in development funding received over the past two years from
several federal agencies, including the DoD, the Biomedical Advanced
Research and Development Authority (BARDA) of the Department of Health and
Human Services (HHS), and the National Institute of Allergy and Infectious
Diseases of the National Institutes of Health.
"The tremendous programmatic and funding support from these US government
agencies is instrumental in the successful development of CBLB502 working
towards FDA licensure," said Fonstein. "CBLI views this support as a
partnership to ensure that both the DoD and, potentially the HHS, have a
capability to protect individuals against the terrorist threat of a
radiation event."
Andrei Gudkov, Ph.D., D. Sci., Chief Scientific Officer for Cleveland
BioLabs and Senior Vice President of Basic Research at Roswell Park Cancer
Institute, also shared some background on CBLB502 and its properties.
A webcast archive of the press conference will be posted at
www.cbiolabs.com under the Investors tab.
About CBLB502
CBLB502 is a derivative of a microbial protein, which has demonstrated the
capacity to reduce injury from acute stresses, such as radiation in animal
models. CBLB502 mobilizes several cell 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 pharmacodynamic drug marker 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. There is currently no FDA approved
medical countermeasure to treat ARS.
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.