SOURCE: Cleveland BioLabs, Inc.

November 09, 2007 08:30 ET

Cleveland BioLabs Founding Partner Cleveland Clinic Receives Department of Defense Grant to Study Protectans CBLB502 and CBLB612 for Tourniquet and Other Battlefield Uses

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.

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

  • Contact:
    Rachel Levine
    Director Corporate Development & Communications
    Cleveland BioLabs, Inc.
    T: (646) 284-9439
    E: rlevine@hfgcg.com