Cleveland BioLabs, U.S. Department of Defense other news
Cleveland BioLabs received a $770,442 increase to its $1.6 million contract with the DoD's Defense Threat Reduction Agency (DTRA) issued in January 2011 to develop entolimod ( CBLB502) to treat acute radiation syndrome (ARS). The increase brings the total value of the contract to $2.4 million. The company already has a separate $46.2 million contract with the DoD's Chemical Biological and Medical Systems (CBMS) (see BioCentury, July 11, 2011).
Cleveland BioLabs also said it received the August meeting minutes and FDA feedback on the human clinical safety protocol for CBLB502. According to the company, the agency provided guidance on the structure of the remaining outcome trials, which will generate additional biomarker information for dose conversion as well as extended safety data using the projected efficacious dose defined by the initial dose conversion study. In September, Cleveland BioLabs said it would need the minutes and the agency's feedback on the human clinical safety protocol before applying for funding from government agencies, including HHS's Biomedical Advanced Research and Development Authority (BARDA) (see BioCentury, Sept. 17). ...