Cleveland Biolabs, a company out of St. Buffalo, NY, has received the first US patent for technology to make drugs to treat radiation exposure in mammals. The Protectan system utilizes flagellin protein to mess with the mechanisms of apoptotic cell death, specifically focusing on how those mechanisms differ between normal and tumor cells.
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 cell 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. 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.