A re-evaluation of fumagillin selectivity towards endothelial cells.
We have re-evaluated the selectivity of fumagillin against endothelial cell proliferation and compared it to the reported selectivity of its potent analog TNP-470. We showed that fumagillin does not inhibit endothelial cell proliferation in a specific manner, but on the contrary it inhibits the proliferation of other cell types at the same range of concentrations. Furthermore, the IC 50 values of fumagillin for endothelial cells are two orders of magnitude higher than those values reported for TNP-470 on endothelial cells; on the contrary, the IC 50 value of fumagillin for human breast cancer MDA-MB231 cells is four orders of magnitude lower than the value reported for TNP-470 on the same cell line.
This article is to introduce FDA's(Food and Drug Administration,FDA)considerations of non-inferiority design used in anti-bacterial drug clinical trial.Non-inferiority study designs may be appropriate when there is adequate evidence of a defined effect size for the control treatment,so that the proposed non-inferiority margin can be supported.