Cancer Prevention Research Publishes Preclinical Studies on Suppression of Breast Cancer Tumor Formation and Progression Using CBL0137

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| Source: Cleveland BioLabs, Inc.

BUFFALO, N.Y., July 2, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI)and its subsidiary, Incuron, LLC, announced today that a study demonstrating that CBL0137 counteracts tumor formation in a mouse spontaneous breast cancer model was published online in Cancer Prevention Research, a peer-reviewed publication of the American Association for Cancer Research. The paper was co-authored by scientists at Roswell Park Cancer Institute and Cleveland BioLabs.

The published study evaluated the effect of CBL0137 on mammary tumor formation in MMTV-neu transgenic mice.  These mice are genetically predisposed to spontaneously develop breast cancer due to enforced expression of Her2/Neu, a proto-oncogene whose expression is strongly associated with the aggressiveness of breast cancer in humans.  In the study, mice were continuously administered CBL0137 orally, via their drinking water, starting at 12 weeks of age. Overall, the tested regimen of CBL0137 treatment had a strong preventive effect on cancer development in this model.  Depending on the concentration of CBL0137 administered, the study authors observed inhibited tumor onset, delayed tumor progression, and prolonged survival among the study animals.  Importantly, continuous long-term CBL0137 treatment did not cause any detectable damage to normal organs and tissues. 

The rationale for evaluating CBL0137 as a cancer treatment in the MMTV-neu mouse model was based upon the previously deciphered mechanism of action of CBL0137.  By altering the activity of the FACT (facilitates chromatin transcription complex), CBL0137 simultaneously modulates three signal transduction pathways (p53, NF-kappaB and heat shock response) that are known to be important for tumor formation (Gasparian, et al., 2011. Curaxins: Anticancer Compounds that Simultaneously Suppress NF-kB and Activate p53 by Targeting FACT. Science Translational Medicine 3(95):95ra72).  Moreover, FACT was found to be overexpressed in breast cancer, suggesting its potential as a therapeutic target.

Andrei Gudkov, Ph.D., D.Sci., Chief Scientific Officer of Cleveland BioLabs, Senior Vice President of Basic Science at Roswell Park Cancer Institute and a co-author of the paper, stated, "These initial results further substantiate our earlier published findings regarding CBL0137's mechanism of action. If proven in future clinical studies, the potential ability of CBL0137 to prevent tumor formation could have an enormous impact on the development of general cancer prophylaxis, especially in subpopulations genetically predisposed to cancer.  The fact that CBL0137 did not appear to cause any measurable toxicity during continuous administration throughout a significant period of the study animals' lives also suggests a benign safety profile."

CBL0137 is a proprietary small molecule with a unique mechanism of action that is in development for oncology applications.  An Investigational New Drug (IND) application for clinical testing of orally administered CBL0137 was recently opened with the regulatory authority of the Russian Federation. A similar program aimed at developing an intravenous formulation of CBL0137 is ongoing in the United States, and a pre-IND meeting was recently conducted with the U.S. Food and Drug Administration. 

The publication (Koman IE, et al., 2012. Targeting FACT complex suppresses mammary tumorigenesis in Her2/neu transgenic mice. Cancer Prevention Research, in press) can be accessed at:

http://cancerpreventionresearch.aacrjournals.org/content/early/2012/06/09/1940-6207.CAPR-11-0529.abstract.

About Incuron, LLC

Incuron, LLC is a Russian Federation-based joint venture founded in 2010 between the Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and Cleveland BioLabs.  Incuron is currently developing lead drug candidates CBL0102 and CBL0137 for oncology and orphan indications.  To learn more about Incuron, LLC, please visit the company's website at http://www.incuron.com/.

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia 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.

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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 Investor Relations & Communications

Cleveland BioLabs, Inc.

T: (646) 284-9439

E: rlevine@cbiolabs.com

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