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Apr 20 2007, 4:30 AM EST

Cleveland BioLabs Protectan CBLB612 Demonstrates Efficacy in Stimulating Proliferation and Mobilization of Bone Marrow Stem Cells in Primate Model

PRNEWSWIRE

CLEVELAND, April 20 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. (Nasdaq: CBLI; Boston Stock Exchange: CFB), today announced the results of a study of the effects of Protectan CBLB612, the lead compound in the Protectans 600 series, on proliferation and mobilization to peripheral blood of pluripotent hematopoietic stem cells in a primate model (Rhesus macaques).

CBLB612 was found to be highly efficacious in stimulating proliferation and mobilization of hematopoietic stem cells into peripheral blood in these primates. A single injection of CBLB612 in Rhesus macaques resulted in a 20- fold increase of hematopoietic progenitor cells in blood. At the peak of the effect (48-72 hours post-injection) the proportion of free-floating CD34+ cells in the total white blood cell count reached 30% (compared with 1.5% in normal blood). CD34 is a molecule present on certain cells within the human body. Cells expressing CD34, otherwise known as CD34+ cells, are normally found in the umbilical cord and bone marrow as hematopoeitic cells.

Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., commented, "The results of this study are outstanding and further support the potential of Protectan CBLB612 as a convenient source of adult stem cells mobilized in peripheral blood. We believe that the effects of CBLB612 on stem cell proliferation and mobilization may be even further improved after we complete a series of dose/schedule optimization studies."

A common current therapeutic approach for increasing the amount of hematopoietic stem cells in blood is multiple injections of granulocyte-colony stimulating factor or G-CSF (Neupogen(R), Granocyte(R), Neulasta(R)). G-CSF is a human growth factor that works by inducing bone marrow to produce more white blood cells and early hematopoietic stem cells in particular. The effect of a single dose of CBLB612 on the proportion of hematopoietic progenitor cells in blood was comparable to that of four daily injections of G-CSF.

A report published by the National Institute of Health (NIH) division of the Department of Health and Human Services entitled "Regenerative Medicine 2006," notes that hematopoietic stem cells have been used clinically since 1959 and are used increasingly routinely for transplantations, albeit almost exclusively in a non-pure form. More than 40,000 transplants were performed annually worldwide by 1995. Currently, the main indications for bone marrow transplantation are either hematopoietic cancers (leukemias and lymphomas), or the use of high-dose chemotherapy for nonhematopoietic malignancies (cancers in other organs). Other indications include diseases that involve genetic or acquired bone marrow failure, such as aplastic anemia, thalassemia sickle cell anemia, and increasingly, autoimmune diseases.

Recent research efforts utilizing adult stem cells include a study in Brazil, which used stem cells made from patients' own blood to treat Type I diabetes. Preliminary results of the treatment, which were detailed in the April 11 Journal of the American Medical Association, showed that 13 of the 15 patients have so far been able to able to stop using insulin to treat their disease. Researchers at Imperial College in London have also used adult stem cells cultivated from bone marrow to grow a human heart valve.

Cleveland BioLabs's Protectans 600 series are modified factors of Mycoplasmas. 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 hematopo

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