SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

September 29, 2009 08:30 ET

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

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.

Contact Information

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