Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
National Institute of Allergy and Infectious Diseases Awards Cleveland BioLabs Grant for Protectan CBLB502 Research in Mitigation of Radiation Damage
Supports Investigation of Ability to Reduce Occurrence and Severity of Thrombocytopenia and Improve Recovery Time
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - September 12, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that it has been awarded a $774,183 grant from the National
Institute of Allergy and Infectious Diseases (NIAID) of the National
Institutes of Health (NIH), to further study certain mitigating properties
of Protectan CBLB502 in the context of hematopoietic (blood/bone marrow)
damage from radiation exposure. The grant program, Medical Countermeasures
to Enhance Platelet Regeneration and Increase Survival Following Radiation
Exposure, is funded through the Project BioShield Act of 2004 and
administered by the Department of Health and Human Services.
The goal of this program is to accelerate the development of safe and
effective medical products to mitigate and treat thrombocytopenia and to
enhance platelet regeneration after radiation exposure from radiological
and nuclear terrorist attacks. Specifically, this initiative supports
research and development of promising new approaches and medical products
to enhance platelet regeneration and yield improved survival.
Among the most important medical countermeasures against acute radiation
syndrome are those that will treat or mitigate its hematopoietic component.
Certain radiation exposures can cause severe damage to the bone marrow,
which can have dramatic effects on circulating blood cells, including
platelets, neutrophils, lymphocytes, and erythrocytes. Platelets play an
essential role in hemostasis and thrombosis. As the level of circulating
platelets drops below 20,000/mm3 (a condition referred to as "severe
thrombocytopenia"), the risk to an affected individual for catastrophic
hemorrhage increases markedly. Severe thrombocytopenia is clearly a
contributor to mortality following radiation exposure. Currently, there is
no approved therapeutic drug in the Strategic National Stockpile for this
radiation-induced complication.
"We are gratified by the federal government's continued support of our
Protectan CBLB502 program," commented Andrei Gudkov, Ph.D., D. Sci.,
Cleveland BioLabs Chief Scientific Officer and Principle Investigator on
the grant. "This grant in particular focuses on the remarkable ability of
Protectan CBLB502 to mitigate the occurrence and severity of
thrombocytopenia, as well as accelerate recovery time in non-human primate
models. We will be further examining this aspect of Protectan CBLB502's
activity and working towards optimizing potential regimens of
administration for enhanced mitigation of radiation-induced
thrombocytopenia and mortality. Protectan CBLB502's multiple mechanisms of
action set it apart from other potential radiation protectors or
mitigators, in part due to its activity in both hematopoietic and
gastrointestinal aspects of acute radiation syndrome. Protectan CBLB502
may represent a valuable potential addition to the Strategic National
Stockpile."
Cleveland BioLabs recently received an allowance from the U.S. Food and
Drug Administration (FDA) to begin Phase I clinical trials in human
volunteers with Protectan CBLB502. Protectan CBLB502 is being developed
under the FDA's animal efficacy rule to treat radiation injury following
exposure to radiation from nuclear or radiological weapons, or from nuclear
accident. This approval pathway requires demonstration of efficacy in two
animal species and safety and drug metabolism testing in a representative
sample of healthy human volunteers. Protectan CBLB502 has demonstrated
activity as a radioprotectant in several animal species, including
non-human primates.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company
leveraging its proprietary discoveries around programmed cell death to
develop treatments for cancer and protection of 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 Radiobiology Research
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. The
Company's 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 the Company's periodic filings with the
Securities and Exchange Commission.