September 12, 2008
National Institute of Allergy and Infectious Diseases Awards Cleveland BioLabs Grant for Protectan CBLB502 Research in Mitigation of Radiation Damage
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.
Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: [email protected]
SOURCE: Cleveland BioLabs, Inc.