Cleveland BioLabs Protectan CBLB612 Produces Breakthrough In Bone Marrow Stem Cell Transplant Study

Main Category: Transplants / Organ Donations
Also Included In: Stem Cell Research;  Blood / Hematology;  Cancer / Oncology
Article Date: 22 May 2007 - 0:00 PDT

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Cleveland BioLabs, Inc. (Nasdaq: CBLI) (Boston Stock Exchange: CFB), today announced the results of a study of the efficacy of Protectan CBLB612, in an animal bone marrow stem cell transplantation model.

Blood from healthy mice treated by Protectan CBLB612 was transplanted into mice that received a lethal dose of radiation that killed hematopoietic (bone marrow/blood production) stem cells. A small amount of blood from the CBLB612 treated mice successfully rescued the mice with radiation-induced bone marrow stem cell deficiency. 100% of the deficient mice transplanted with blood from CBLB612 treated mice survived past the 60-day mark, while 85% of the untreated deficient mice died within the first three weeks of the experiment. The 60- day mark is considered to be the critical point in defining the presence of long-term adult bone marrow stem cells, which are capable of completely restoring lost or injured bone marrow function. The rescuing effect of the peripheral blood of the treated mice was equivalent to that of conventional bone marrow transplantation.

Cleveland BioLabs President and Chief Executive Officer, Michael Fonstein, Ph.D., commented, "We are very excited about the results we have achieved to date in our studies of Protectan CBLB612 as an effective producer of long-term adult bone marrow stem cells in peripheral blood. The transplant study in particular, has advanced our research into clinical applications and suggests multiple potential uses within the field of regenerative medicine."

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.

Administration of Protectan CBLB612 increases the level of a number of cytokines known to stimulate blood regeneration. This compares to the current clinical practice of administering a single purified cytokine, such as G-CSF (Neupogen(R), Granocyte(R), Neulasta(R)). Protectan CBLB612 stimulates production of adult bone marrow stem cells through multiple mechanisms, making it potentially more effective than currently used clinical protocols. In addition, Protectan CBLB612 could be used in treating those individuals that do not respond to G-CSF.

In addition to efficacy in stimulation and mobilization of stem cells, 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 blood production system following lethal doses 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 Foundation, 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 filings with the Securities and Exchange Commission.

Cleveland BioLabs, Inc.
http://www.cbiolabs.com