FDA blasts Isner's VEGF trials

The FDA has accused Vascular Genetics Inc. founder Jeffrey Isner of violating regulations governing the conduct of clinical trials and human subject protections, putting subjects at risk in trials of Vascular Endothelial Growth Factor Plasmid (VEGF-2) and jeopardizing the accuracy of the trial results.

The trials involved the use of VEGF-2 to treat coronary artery disease and peripheral artery disease. In an April 28 Warning Letter, FDA said the violations included failure to protect the welfare of subjects, enrollment of ineligible subjects, failure to obtain informed consent and failure to inform the Institutional Review Board (IRB) of unanticipated problems involving risk to human subjects. ...