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Cleveland BioLabs Receives First U.S. Patent for Radiation Protection Drug CBLB502
Wednesday, January 06, 2010
Buffalo, NY -- Cleveland BioLabs, Inc. (Nasdaq: CBLI) announced today that the U.S. Patent and Trademark Office has issued US Patent No. 7,638,485 titled "Modulating Apoptosis" covering the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502. This patent was already granted by the nine member countries of the Eurasian Patent Organization (EAPO), and two additional nations.
Cleveland BioLabs has also filed two additional new patent applications related to Protectan technology in the U.S. around various aspects and properties for CBLB502 and related Protectan compounds, including new methods of use of flagellin derivatives and screening for new compounds with similar properties.
Yakov Kogan, Ph.D., MBA, Chief Operating Officer of Cleveland BioLabs, noted, "With more than 13 sets of patents filed to date in the U.S. and internationally around various properties of CBLB502 and related compounds, we believe we have protected the potentially broad uses of our Protectan technology. The receipt of our first U.S. patent for protection from radiation is a major milestone in our development of CBLB502 and we continue to advance our work in this and other areas of protection from acute stresses."
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 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. 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.
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