SOURCE: Cleveland BioLabs, Inc.

December 12, 2007 10:14 ET

Cleveland BioLabs Protectan CBLB612 Outperforms Market Leading Hematopoietic Stem Cell Stimulator in Mouse Study

Demonstrates Potential Breakthrough for Minimally Invasive and More Effective Blood Stem Cell Collection

BUFFALO, NY--(Marketwire - December 12, 2007) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced the results of a study of the effects of CBLB612, the lead compound in the Protectans 600 series, on propagation and mobilization to peripheral blood of hematopoietic (bone marrow/blood) stem cells (HSC) in comparison with G-CSF, the current market leading product, in mice.

Direct comparisons of CBLB612 and G-CSF, injected as single agents or in combination with AMD3100, a promising clinical-stage stem cell mobilizer developed by AnorMED Inc., demonstrated much stronger efficacy of CBLB612 as a stimulator and mobilizer of HSC in peripheral blood.

In this study, a single injection of CBLB612 was given in combination with the current standard methodology for stem cell donor isolation, which is four daily injections of G-CSF followed by one injection of AMD3100. The addition of CBLB612 to the protocol yielded eight to ten times higher concentrations of short-term and long-term HSC in peripheral blood, respectively, compared to the standard protocol. Even a single administration of CBLB612 in combination with AMD3100 yielded twice as many mobilized HSC compared with that of the standard regimen. Furthermore, CBLB612 mobilized all major classes of HSC to peripheral blood, suggesting that no HSC classes would be lost in the enrichment process.

Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs, commented, "This study represents a potential paradigm shift in the methodology for HSC mobilization and collection. Administration of Protectan CBLB612 increases the level of a number of cytokines known to stimulate blood regeneration, versus the current practice of administering a single purified cytokine, such as G-CSF. The increase in the number of mobilized stem cells to peripheral blood was such that one should expect complete restoration of the hematopoietic and immune system in an immuno-compromised recipient with whole blood transfusion from a CBLB612-treated donor. In fact, this might even be possible without aphaeresis (a process whereby donor blood is separated and HSC removed for collection) or bone marrow transplantation. Moreover, Protectan CBLB612 could be used in treating those individuals that do not respond to G-CSF."

Adult hematological bone marrow stem cell transplantation is currently used for hematological disorders (malignant and non-malignant), as well as some non-hematological diseases, such as breast cancer, testicular cancer, neuroblastoma, ovarian cancer, Severe Combined Immune Deficiency (SCID), Wiskott-Aldrich syndrome, and Chediak-Higashi syndrome.

Cleveland BioLabs's Protectans 600 series are modified factors of Mycoplasmas. Protectan CBLB612 has been shown to be highly efficacious as a stand-alone treatment in stimulating proliferation and mobilization of hematopoietic stem cells into peripheral blood in both mice and primates. A single injection of CBLB612 in Rhesus macaques resulted in a 20-fold increase of hematopoietic progenitor cells in blood. It was also shown that a small amount of blood from CBLB612 treated mice successfully rescued mice with radiation-induced bone marrow stem cell deficiency. 100% of the deficient mice transplanted with blood from CBLB612 treated mice survived past the 120-day mark, while 85% of the untreated deficient mice died within the first three weeks of the experiment.

In addition, Protectan CBLB612 has demonstrated both radiation protection and mitigation properties over a very broad time window of use. In animal experiments, Protectan CBLB612 has produced complete and sustained recovery of the hematopoietic system following lethal doses of radiation when given 48 hours before or up to 24 hours after the event of radiation.

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect 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 Research Radiobiology 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. Our 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 our periodic filings with the Securities and Exchange Commission.

Contact Information

  • Contacts:
    Rachel Levine
    Director Corporate Development & Communications
    Cleveland BioLabs, Inc.
    T: (646) 284-9439
    E: rlevine@cbiolabs.com