Cleveland Bio (Nasdaq: CBLI) and Incuron Announce Positive Study Results

Orlando, FL 6/21/12 (StreetBeat) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) 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.

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