Cleveland BioLabs and Incuron Announce Results of Studies of CBL0137 in Animal Models of Neuroblastoma

Cleveland BioLabs and Incuron Announce Results of Studies of CBL0137 in Animal Models of Neuroblastoma

BUFFALO, N.Y., Jun 21, 2012 (GlobeNewswire via COMTEX) -- Cleveland BioLabs, Inc. CBLI -4.08% and its subsidiary, Incuron, LLC, today announced the results of new studies demonstrating potentially curative effects of CBL0137, in combination with chemotherapy in animal models of neuroblastoma. The results were presented at the Advances in Neuroblastoma Research (ANR) Association 2012 meeting, the world's largest forum on this challenging childhood malignancy, on June 20, 2012, in Toronto, Ontario.

Professor Michelle Haber, Ph.D., Executive Director of Children's Cancer Institute Australia and President of the ANR Association, described the studies in her lecture titled, "Anticancer Compounds that Simultaneously Suppress NF-kB and Activate p53 are Highly Effective at Delaying Tumor Development and Progression in the TH-MYCN Mouse Model of Neuroblastoma."

Dr. Haber's presentation featured a series of experiments conducted in close collaboration between scientists at Children's Cancer Institute Australia, Roswell Park Cancer Institute, Cleveland BioLabs and Incuron, in which CBL0137 combined with cyclophosphamide and topotecan, the standard chemotherapeutic agents for relapsed neuroblastoma treatment, was tested in TH-MYCN mice with spontaneous neuroblastomas that closely mimic human neuroblastoma. When administered separately, CBL0137 and standard chemotherapy showed a delay in tumor development and prolongation of survival, although neither treatment alone was capable of causing complete tumor regression. When CBL0137 was given either orally or intravenously in combination with cyclophosphamide and topotecan, however, complete tumor regression was achieved in 100% of the study animals.

"We are very excited by the outcome of these studies," stated Dr. Haber. "We have been working with this model for many years and have tested numerous therapeutic approaches, but this is the first time we have achieved complete regression in tumor-bearing animals. The results of these studies using CBL0137 in combination with cyclophosphamide and topotecan offer hope to physicians, patients and their families, and encourage us to make further progress with this research as quickly as possible."

Neuroblastoma is the most frequently occurring solid tumor encountered in early childhood and is often difficult to treat successfully.

CBL0137 is a proprietary small molecule with a unique mechanism of action that is in development for oncology applications. Studies have shown that the drug acts by blocking activity of chromatin remodeling complex FACT, resulting in simultaneous modulation of three signal transduction pathways (p53, NF-kappaB and heat shock response) commonly deregulated in cancer. An Investigational New Drug (IND) application for clinical testing of the oral administration of 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. Completion of Phase I trials in adults is a prerequisite for the initiation of trials in children.

More information on the Advances in Neuroblastoma Research Meeting may be found at: www.anr2012.com .

About Incuron, LLC

Incuron, LLC is a Russian Federation based joint venture founded in 2010 between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and Cleveland BioLabs. Incuron is developing 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 .

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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Cleveland BioLabs, Inc.

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