Thursday, March 24, 2011

CBLB502: Efficacious and Safe, So Far

A Staff Writer at the Pharmaceutical Business Review reported on May 10, 2010, that "Cleveland BioLabs has completed the dosing of healthy volunteers in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).  Cleveland BioLabs said that CBLB502 is being developed under the FDA's Animal Efficacy Rule [known as "fast-tracking" - ed.] to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon/dirty bomb, or from a nuclear accident. The approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers.  Additionally, evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008.  Data from 50 human subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalised biomarker results corresponded to previously demonstrated activity in animal models of ARS.  The second safety study included a total of 100 healthy human volunteers randomised among four dosing regimens of CBLB502.  Participants in the study were monitored for adverse side effects and blood samples were obtained to assess the effects of CBLB502 on various biomarkers and to further characterise the pharmacokinetics of CBLB502.  Reportedly, the primary objectives of this study are to gather additional data on safety, pharmacokinetics, and cytokine biomarkers in a larger and broader subject population in order to finalise an appropriate dose to take forward for the large, definitive human volunteer safety study.  Cleveland BioLabs said that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services has supported the entire cost (approximately $1.3m) of this clinical Phase 1b human safety study as part of contract."  Sounds like something they may need in Japan sooner rather than later.