BioCentury
ARTICLE | Company News

Cleveland BioLabs, U.S. Department of Health and Human Services (HHS) other news

October 29, 2012 7:00 AM UTC

Cleveland BioLabs submitted a proposal to HHS's Biomedical Advanced Research and Development Authority (BARDA) to fund the remaining development steps needed for FDA approval of entolimod ( CBLB502) as a medical radiation countermeasure. Cleveland BioLabs said the scope of the proposal is based on FDA feedback and is intended to address points noted by BARDA relating to Cleveland BioLabs' previous proposal.

Earlier this month, Cleveland BioLabs 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 BARDA (see BioCentury, Sept. 17 & Oct 8). ...