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