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DMHS Defense
Military Health Systems |
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Cleveland BioLabs
Submits Response to Department of Defense 'Sources Sought
Notice'
Cleveland BioLabs
December 01, 2006
Response Highlights CBLB502's Efficacy as Radioprotectant,
Preferred Delivery Method, and Safety
Cleveland, OH -- Cleveland BioLabs, Inc. , today announced that
it has submitted its response to the Sources Sought Notice
issued by The Department of Defense (DoD) on November 14,
calling for therapeutic products to treat gastrointestinal
effects of Acute Radiation Syndrome (ARS). |
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Dr. Yakov Kogan,
Executive Vice President of Cleveland BioLabs commented, "Given
the increasing threat and incidence of radiation exposure to
both military personnel and civilians in today's society,
development of compounds to protect against the most damaging
effects of ARS is critical. The DoD's request has reinforced the
importance of protecting the gastrointestinal tract, in addition
to the hematopoietic (immune) system; and we believe that our
Protectan CBLB502 offers unique advantages over other
therapeutics through its ability to protect both systems before
and after exposure."
The Company's response included several features of Protectan
CBLB502 as both a radioprotectant and mitigator of radiation
exposure: CBLB502 is effective as a radioprotectant when
administered as little as 15 minutes prior to exposure and as a
mitigator, if administered up to one hour after exposure. In
addition, CBLB502 is stable in solution and powder form, so it
can be quickly dissolved and injected using self-injectable
devices, which are the preferred delivery system in the field.
Moreover, the compound does not display toxicity at therapeutic
doses.
Research has demonstrated that a single injection of less than
1% of the maximum tolerable dose of CBLB502 rescues greater than
80% of NIH Swiss mice from as high as 13 Gy of total body
irradiation. Other known compounds in development show no
protective effect from this level of radiation exposure. CBLB502
also showed strong radioprotective efficacy as a single therapy
in non-human primates, enabling survival of 70% of the animals
that received whole-body radiation, versus the control group, in
which 75% of the animals died.
Of those monkeys in the control group that survived, none were
without significant abnormalities, suggesting that long-term
deleterious effects from the radiation were likely. In contrast,
surviving monkeys treated with CBLB502 possessed no significant
structural abnormalities in bone marrow, immune system organs,
or small intestines at the 40-day mark. This is consistent with
data obtained from mice. Irradiated mice treated with CBLB502
survived the duration of their remaining normal life span
without development of any significant abnormalities and
preserving normal formation of blood cells (hematopoiesis). This
data suggests that CBLB502 offers true protection from
gamma-irradiation induced ARS, including the lethal effects on
both gastrointestinal and hematopoietic systems.
CBLB502 is undergoing an accelerated development program under
the FDA two-animal rule, which requires the Company to show
efficacy in two animal species (including primates) and only
safety in humans.
The Sources Sought Notice called for Prime Contractor(s) for
advanced development activities associated with therapeutic
products to either prevent or reduce the extent of incipient
radiation injury or promote repair of manifest radiation injury
to allow preservation or restoration of the anatomic integrity
and normal physiologic functioning of the gastrointestinal
tract. These therapeutic products are being developed in
response to a requirement to treat Armed Forces service members
for the effects of radiation injury and to allow commanders to
sustain and continue operations in the event of nuclear or
radiological attacks on U.S. Forces.
The Department of Defense's Sources Sought Notice can be
publicly accessed from the following URL: http://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M07S0001/SynopsisR.html.
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,
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 that
reflect our current view with respect to various aspects of the
events described above. Actual results could be significantly
different. Factors that could affect results include those set
forth in filings made by Cleveland BioLabs, Inc. with the
Securities and Exchange Commission. These factors include, but
are not limited to, those discussed in our Registration
Statement on Form SB-2 under the caption "Risk Factors." |
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