Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Department of Defense Increases Ongoing Contract With Cleveland BioLabs for Developmental Studies Related to Protectan CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - October 6, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that the Chemical Biological Medical Systems Medical
Identification and Treatment Systems Joint Program Executive Office
(CBMS-MITS JPEO) of The Department of Defense (DoD) increased the Company's
ongoing contract, awarded in April 2008 for developmental studies related
to Protectan CBLB502, from $8.86 million to $9.59 million. The additional
funds are intended to support bridging studies.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland
BioLabs, stated, "We are gratified by the continued support demonstrated by
the CBMS-MITS JPEO."
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 by Cleveland BioLabs 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 its development of CBLB502,
Cleveland BioLabs will be conducting 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 30, 2009.