BUFFALO, N.Y., Nov. 6, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) announced today the online publication in the Journal of Immunology of a study demonstrating efficacy of Entolimod™ (previously known as CBLB502) in improving the graft-versus-tumor (GVT) activity of allogeneic bone marrow transplantation (allo-BMT) in a mouse model. The reported studies were conducted by scientists at Roswell Park Cancer Institute (RPCI) and Cleveland BioLabs.

Entolimod™ is a Toll-like receptor 5 (TLR5) agonist currently under development as a radiation countermeasure. Allo-BMT is an established treatment for leukemia, lymphoma, and other hematologic and non-hematologic malignancies in which donor-derived immune cells (specifically, CD8+ T cells) identify and attack host tumor cells, producing a beneficial GVT effect.

The results of the study showed that Entolimod™ treatment significantly enhanced allogeneic CD8+ T cell-mediated GVT activity, as evidenced by decreased tumor burden and improved host survival. For example, 60% of mice that received Entolimod™ treatment in addition to allo-BMT were alive and tumor-free on Day 60 after lymphoma cell injection, while 100% of mice given allo-BMT alone were dead by Day 32 due to tumor outgrowth. Importantly, histopathology analyses on the subject mice showed that Entolimod™ treatment did not exacerbate graft-versus-host disease (GVHD) that often arises as a complication of allo-BMT due to the attack on healthy host tissues by transplanted donor cells.

The study also provided insight into the mechanism underlying Entolimod™'s ability to enhance the GVT effect of allo-BMT. It was shown that Entolimod™ acts independently of the TLR5 status of the tumor through specific populations of hematopoietic cells in the bone marrow (CD11b+ dendritic cells and CD11c+ myeloid cells), which respond by secreting the cytokine IL-12. This cytokine then acts upon donor CD8+ T cells, resulting in stimulation of their proliferation and enhancement of their tumor-killing capacity.

Andrei Gudkov, Ph.D., D.Sci., Chief Scientific Officer of Cleveland BioLabs, Senior Vice President of Basic Science at Roswell Park Cancer Institute and co-author of the paper, commented: "This study extends potential therapeutic applications of Entolimod™ to include use in combination with allo-BMT to increase its anti-tumor efficacy without exacerbating GVHD.  It also underscores the importance of mechanistic studies conducted as part of our radiation countermeasure program, which have helped us better understand Entolimod™'s ability to promote beneficial immune responses that could impact a broad range of medical scenarios far beyond radiation protection/mitigation."

Annually, there are approximately 20,000 cases of allo-BMT worldwide and about 6,000 cases in the U.S., with roughly 35-50% of cases developing GVHD.

The Journal of Immunology publication may be found online at: http://www.ncbi.nlm.nih.gov/pubmed/23045613

About Roswell Park Cancer Institute (RPCI)

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI's website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

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.

The Cleveland BioLabs, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11668

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.

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

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