Cleveland BioLabs preclinical data

Cleveland BioLabs reported data from 179 non-human primates in a blinded, placebo-controlled, dose-ranging study showing that a single injection of CBLB502 given 25 hours after a 70% lethal dose of total body irradiation met the primary endpoint by demonstrating a significant dose-response relationship on overall survival (OS) at day 60 (p=0.0021 for the trend up to 10 µg/kg CBLB502 and p<0.0001 for the trend up to 40 µg/kg CBLB502). Specifically, doses above the minimal efficacious dose of CBLB502 led to a 60-day OS rate of about 75% vs. 27.5% for placebo. The company said it plans to use the data as a basis for finalizing its remaining development steps with FDA and for submitting a BLA in 2014.

In April, HHS's Biomedical Advanced Research and Development Authority (BARDA) indicated that it will not invite Cleveland BioLabs to submit a funding proposal for CBLB502 to treat ARS. In a conference call, Cleveland BioLabs said BARDA "did not agree that our proposed studies were the proper studies to move ahead with FDA approval" (see BioCentury, April 9). ...