Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@hfgcg.com
Cleveland BioLabs Founding Partner Cleveland Clinic Receives Department of Defense Grant to Study Protectans CBLB502 and CBLB612 for Tourniquet and Other Battlefield Uses
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - November 9, 2007) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that its academic and founding partner, Cleveland Clinic,
received a $1 million grant from the Department of Defense to conduct
pre-clinical studies on two of the Company's lead compounds, Protectan
CBLB502 and Protectan CBLB612, for use in tourniquet and other
ligation-reperfusion battlefield injuries where blood flow is stopped and
then restored after a prolonged period of time.
The tourniquet has been used for over 300 years for effective hemorrhage
control during surgery and trauma. While properly applied tourniquets are
extremely effective in controlling hemorrhage, their use is far from
benign. Tourniquet-related injury consists of compression injury to the
underlying skin, nerve, and muscle, as well as reperfusion injury to the
underlying and distal muscle and nerve. When tourniquets applied for long
durations are removed, a severe systemic inflammatory response leading to
damage to remote organs can take place, in some cases resulting in
fatality.
Military statistics show two-thirds of all combat-related deaths are due to
bleeding; and 80% of those deaths occur within 15 minutes of injury. The
tourniquet is the first line of defense for the soldier in the battlefield.
Statistics also show the rate of limb amputation due to battlefield
arterial wounds has not improved since World War II, despite aggressive
advances in surgical treatment.
To date, Protectan CBLB502 and Protectan CBLB612 have primarily been
developed as radiation protectors and mitigators, due to their respective
capacities to temporarily delay apoptosis, or regulated cell death, in
certain tissues and thereby enable repair of damage. Apoptosis also plays
a significant role in tissue injury occurring as a result of DNA damage
caused by ligation-reperfusion conditions, such as those caused by
tourniquet use.
CBLI researchers in collaboration with investigators from Cleveland Clinic
have demonstrated that a single injection of Protectan CBLB502 effectively
prevents acute renal failure and subsequent death in a mouse model of
ischemia-reperfusion renal injury.
Ganes Sen, Ph.D, Principal Investigator on the grant and the Interim
Chairman of the Department of Molecular Genetics at Lerner Research
Institute at Cleveland Clinic, said, "We are excited to pursue additional
anti-ischemia applications for Cleveland BioLabs' Protectan compounds.
Their proven success in delaying apoptosis in animal models of radiation
makes ligation-reperfusion injury a logical extension of their use. If we
will be able to demonstrate the ability of Protectans to reduce tissue
damage caused by the tourniquet and prevent excessive bleeding from wounded
limbs, it may significantly broaden the use of tourniquet in the medical
practice, which has been limited by the high risk of loss of limbs as a
result of prolonged tissue hypoxia."
Andrei Gudkov, Ph.D, D. Sci., Chief Scientific Officer of Cleveland BioLabs
and the inventor of the technology, noted, "We are eager to conduct further
studies of this application for our Protectan compounds with Cleveland
Clinic, which is a leader in many medical fields where ligation-reperfusion
damage is commonly encountered. While the potential military use of
Protectans for tourniquet and other ligation-reperfusion injuries is
critical, there are multiple civilian uses in traumas such as car accidents
and organ failure incurred during heart surgery. Statistics show that 50%
of all civilian trauma deaths are from bleeding."
Protectan CBLB502 is undergoing an accelerated development program as the
radiation antidote under the FDA two-animal rule, which requires
demonstrations of efficacy in two animal species and only safety in humans.
The Company plans to submit an Investigational New Drug (IND) application
to the FDA for a human safety study this year.
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 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.
About The Lerner Research Institute
The Lerner Research Institute is home to all laboratory-based research at
Cleveland Clinic. Its mission is to understand the causes of human diseases
and to develop new treatments and cures. The Lerner Research Institute is
ranked fifth in NIH funding among all U.S. research institutes. More than
1,000 scientists work in research programs focusing on cardiovascular,
cancer, neurologic, musculoskeletal, allergic and immunologic, ophthalmic,
metabolic, and infectious disease. The Institute also is an integral part
of Cleveland Clinic Lerner College of Medicine of Case Western Reserve
University -- training the next generation of physician-scientists.
About CCF Innovations
CCF Innovations, the technology commercialization arm of Cleveland Clinic,
stewards the Clinic's technology innovation strategy. It enhances
product-oriented innovation throughout Cleveland Clinic and transforms
promising therapies, devices and diagnostics into beneficial medical
products, via spin-off companies, licensees and equity partnerships.
About Cleveland Clinic
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit
multispecialty academic medical center that integrates clinical and
hospital care with research and education. Cleveland Clinic was founded in
1921 by four renowned physicians with a vision of providing outstanding
patient care based upon the principles of cooperation, compassion and
innovation. U.S. News & World Report consistently names Cleveland Clinic as
one of the nation's best hospitals in its annual "America's Best Hospitals"
survey. Approximately 1,800 full-time salaried physicians and researchers
at Cleveland Clinic and Cleveland Clinic Florida represent more than 100
medical specialties and subspecialties. In 2006, there were 3.1 million
outpatient visits to Cleveland Clinic. Patients came for treatment from
every state and from more than 80 countries. There were more than 53,000
hospital admissions to Cleveland Clinic in 2006. Cleveland Clinic's Web
site address is www.clevelandclinic.org.
Financial Interests
Cleveland Clinic holds a minority equity ownership interest in Cleveland
BioLabs and has the right to receive royalties from Cleveland BioLabs. One
Clinic official serves on the Cleveland BioLabs Board of Directors, and one
or more members of the Clinic's Professional Staff serve as paid
consultants to Cleveland BioLabs. Institutional and individual conflicts
of interest in research are reviewed and managed by the Clinic's Conflicts
of Interest Committee.
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of the Private Securities Litigation Reform Act of 1995. Forward-looking
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