Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Receives First U.S. Patent Allowance for Its Radiation Protection Drug Protectan CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - August 17, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI )
announced today that it has received a Notice of Allowance from the U.S.
Patent and Trademark Office for its U.S. Patent Application Number
11/421,918, titled "Modulating Apoptosis." Allowed claims cover the method
of protecting a mammal from radiation using flagellin or its derivatives,
including Protectan CBLB502. This patent was already granted by the nine
member countries of the Eurasian Patent Organization (EAPO) and two
additional countries.
Cleveland BioLabs has filed 14 sets of patent applications in the U.S. and
internationally, around various aspects and properties for CBLB502 and
related Protectan compounds, including methods of use and composition of
matter.
Yakov Kogan, Ph.D., MBA, Chief Operating Officer of Cleveland BioLabs
noted, "We are extremely pleased to be receiving this patent coverage.
Protectan CBLB502 represents a completely novel approach to protection of
healthy tissues from the impact of radiation and other acute stresses. We
continue to pursue additional claims under this and other patent
applications both in the U.S. and internationally."
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 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 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.