BUFFALO, NY -- (Marketwire) -- 07/01/09 -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today
announced that the Chemical Biological Medical Systems Medical
Identification and Treatment Systems Joint Product Management Office
(CBMS-MITS JPMO) of The Department of Defense (DoD) has exercised the
contract option and released a second phase of funding under a contract
calling for developmental studies valued at up to $8.8 million, awarded in
April 2008.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland
BioLabs, stated, "The release of this phase of funding under our contract
with the DoD is a significant milestone, indicating clear recognition of
our progress. Timing of this release was based upon the CBMS-MITS JPMO's
conclusion that we have successfully achieved the stated goals of our
initial Phase I human safety study for Protectan CBLB502 and are entering
further steps of development under the contract."
Cleveland BioLabs recently announced that data from more than 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 Acute Radiation
Syndrome (ARS). A pattern of biomarker production was observed in humans
consistent with those patterns seen in animals during mitigation of
radiation-induced injury by dosing with CBLB502. This study will be
followed by a second, larger safety study in healthy human volunteers,
building on the results of the initial study.
These studies are being conducted under the U.S. Food and Drug
Administration's Animal Efficacy Rule to treat ARS 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. Demonstration of specific activity in humans is
based on biomarkers that directly reflect the mechanism of the drug's
action. Evidence of CBLB502's mechanism of activity and efficacy in animal
models was published in Science Magazine in April 2008 (Science, 2008, vol.
320, pp. 226-230). 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.
Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com