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Cleveland BioLabs Protectan CBLB612 Demonstrates Significant Reduction of Myelosuppression in Mouse Model of Chemotherapy

October 27, 2008

Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced results of a series of studies demonstrating Protectan CBLB612′s ability to substantially reduce myelosuppression (the most common rate limiting adverse effect of chemotherapy) caused by a widely used chemotherapeutic drug, cyclophosphamide (Cytoxan, Neosar, CTX).

Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs, stated: “Our previous studies established Protectan CBLB612′s activity as a potent stimulator of hematopoetic stem cell proliferation and mobilization to peripheral blood in both mice and non-human primates, as well as its ability to protect lethally irradiated mice from radiation-induced mortality and to restore normal long-term hematopoiesis in surviving animals. In fact, many of these previous studies showed favorable comparisons of a single injection of Protectan CBLB612 to multiple injections of granulocyte-colony stimulating factor or G-CSF (Neupogen(R), Granocyte(R), Neulasta(R)), a common therapeutic approach for increasing the amount of hematopoietic stem cells in blood.”

“The new properties of CBLB612 we are reporting today further broaden the opportunities of its use as a supportive care drug for cancer treatment,” continued Dr. Fonstein. “Specifically, Protectan CBLB612 has potential as a chemotherapy adjuvant, entering one of the biggest medical markets: It is estimated that approximately 40% of the roughly $50 billion annually spent on cancer treatment represents supportive care addressing side effects of various treatments, including chemotherapy.”

In recent studies, mice bearing syngeneic melanomas were treated once a week for two weeks with a 500 mg/kg, or near maximum tolerable dose, of cyclophosphamide, alone or in combination with Protectan CBLB612. Protectan CBLB612 was administered 24 hours after each cyclophosphamide administration. Complete blood counts and tumor growth were evaluated over a three-week period.

Peripheral white blood cell counts were in the range of normal in Protectan CBLB612 treated animals following two independent cyclophosphamide injections, while untreated animals suffered severe leukopenia. The deepest drop of white blood cells in the Protectan CBLB612 treated group on average was to 2.66*103/uL compared to -0.432.66*103/uL in the control group (p < 0.05).

Treatment with Protectan CBLB612 did not interfere with the anti-cancer efficacy of cyclophosphamide and tumor growth was equally reduced in the chemotherapy-treated groups regardless of co-administration with Protectan CBLB612.

Tumor growth was partially diminished in mice that received Protectan CBLB612 alone, compared to animals that were injected only with the vehicle control. This intrinsic anti-tumor effect of Protectan CBLB612 may be related to its immune stimulation properties.

Protectan CBLB612 is a proprietary synthetic analogue of mycoplasma lipopeptides that acts as a powerful stimulator and mobilizer of hematopoietic stem cells (HSC) to peripheral blood. With efficacy and non-GLP safety already studied in mice and non-human primates, CBLB612 is undergoing pre-clinical safety and manufacturing development. Clinical trials for Protectan CBLB612 are projected for early 2010.

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 partnerships 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 http://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. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” 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

SOURCE: Cleveland BioLabs, Inc.




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