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Journal of Immunology Publishes Study of Cleveland Biolabs Inc. (CBLI)' Drug CBLB502 in Acute Renal Ischemic Failure



10/3/2011 9:23:18 AM

BUFFALO, NY--(Marketwire - October 03, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that a study demonstrating CBLB502's ability to inhibit acute renal ischemic failure was published in the October 1, 2011 issue of The Journal of Immunology (J Immunol 2011 187:3831-3839; doi:10.4049/jimmunol.1003238).

The study, conducted by scientists at Cleveland Clinic, Roswell Park Cancer Institute and Hokkaido University, analyzed the ability of CBLB502 to attenuate injury in a murine model of acute ischemic renal failure, a potentially fatal and poorly treatable disease that is frequently developed as a result of decreased blood flow through the kidneys.

CBLB502, given 30 minutes before bilateral renal pedicle occlusion, provided marked protection against the renal dysfunction and inflammation that follows reperfusion of ischemic kidneys. CBLB502 administration caused marked decreases in leukocyte infiltration, pro-inflammatory cytokine production, and tubular injury and resulted in significant improvement of animal survival. Importantly, CBLB502 given within 30 minutes after ischemic kidney reperfusion reproduced the protective effects of pretreatment with the same compound, indicating a window following reperfusion in which CBLB502 administration may mitigate against acute renal ischemic failure. These results indicate the potential for use of TLR5 (toll-like receptor 5) agonists, such as CBLB502, as both mitigators and protectors against acute renal ischemic failure.

Andrei Gudkov, Ph.D., D. Sci., Chief Scientific Officer of Cleveland BioLabs, and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "The spectrum of pathologies that may be addressed by CBLB502's mechanism of action continues to expand. Ischemia-reperfusion injury continues to be a major clinical problem causing significant morbidity and mortality in transplantation as well as in other surgeries. This study and previously collected data on CBLB502's efficacy against tourniquet-induced injury in animal models further reinforces our belief that CBLB502 may be broadly efficacious in protecting against ischemic injury."

CBLB502 is currently at an advanced stage of development for biodefense applications as a medical radiation countermeasure. In January 2011, preclinical data regarding direct anticancer effects of CBLB502 in several mouse and rat models of colon and lung cancer, lymphoma, melanoma, and head and neck cancer was reported.

The Journal of Immunology publication may be found online at: http://www.jimmunol.org/content/early/2011/08/29/jimmunol.1003238

The study cited in the publication was supported by grants from Cleveland BioLabs, Inc., the U.S. Department of Defense, and the National Institutes of Health.

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 relationships 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 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.

These factors include, among others, the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.


Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com


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