Contact Information: Contact: Rachel Levine, Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Awarded $5.3 Million Grand Opportunities Grant From National Institutes of Health for Protectan CBLB502 Research in Mitigation of Radiation Damage of GI Tract
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - September 29, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that it has been awarded a $5.3 million Grand Opportunities (GO)
grant under the American Recovery and Reinvestment Act of 2009 from the
Office of the Director and the National Institute of Allergy and Infectious
Diseases (NIAID) of the National Institutes of Health (NIH). The grant
will fund studies of molecular mechanisms by which Protectan CBLB502
mitigates gastrointestinal (GI) damage from radiation exposure. Cleveland
BioLabs will lead a consortium of collaborators on this project, including
Roswell Park Cancer Institute, Cleveland Clinic, the University of Illinois
at Chicago and Attagene, Inc.
"It is an honor to win such a highly competitive grant," commented Andrei
Gudkov, Ph.D., Chief Scientific Officer of Cleveland BioLabs, Senior Vice
President of Basic Science at Roswell Park Cancer Institute, and Principle
Investigator on the grant. "We are very pleased with the NIH's recognition
of the strength of our program and the importance of CBLB502 as a
radiomitigator. This award is indicative of the success of the unique
partnership between Cleveland BioLabs and Roswell Park Cancer Institute,
which also involves a network of other academic and commercial
collaborators. The grant will not only support our advancement of
Protectan CBLB502 towards completion of a Biologic License Application for
Acute Radiation Syndrome, but also further our study of Protectan CBLB502
as a mitigator of radiation-induced GI damage in medical settings."
The NIH has established the Research and Research Infrastructure Grand
Opportunities or "GO" grants program under the American Recovery and
Reinvestment Act of 2009. The GO grants program supports large-scale
research projects that accelerate critical breakthroughs, early and applied
research on cutting-edge technologies, and new approaches to improve the
synergy and interactions among multi and interdisciplinary research teams.
The initiative was established to seek novel approaches in areas that
address specific knowledge gaps, scientific opportunities, new
technologies, data generation, or research methods that would benefit from
an influx of funds to quickly advance the area in significant ways.
About CBLB502
CBLB502 is a derivative of a microbial protein, which has demonstrated the
capacity to reduce injury from acute stresses, such as radiation, in animal
models. CBLB502 mobilizes several tissue protective mechanisms, including
inhibition of programmed cell death (apoptosis), reduction of oxidative
damage and induction of regeneration-promoting cytokines.
CBLB502 is being developed under the U.S. Food and Drug Administration's
Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation
poisoning from any exposure to radiation such as a nuclear or radiological
weapon/dirty bomb, or from a nuclear accident. This approval pathway
requires demonstration of efficacy in representative animal models and
safety and drug metabolism testing in healthy human volunteers.
Evidence of CBLB502's mechanism of action and activity in animal models was
published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp.
226-230). Data from 50 subjects in an initial Phase I safety and
tolerability study indicated that CBLB502 was well tolerated and that
normalized biomarker results corresponded to previously demonstrated
activity in animal models of ARS. As part of the development of CBLB502,
this study will be followed by a second, larger safety study in healthy
human volunteers, which will be based on the results of the initial study.
There is currently no FDA-approved medical countermeasure to treat ARS.
CBLB502 is also being developed as a supportive care measure to reduce and
prevent occurrence of side effects of radiotherapy or chemotherapy in
cancer treatment.
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.