The pace of Vascular Genetics Inc.'s Phase I/II trials of its VEGF-2 gene therapy in coronary artery disease and critical limb ischemia has out-distanced the company's ability to develop an assay for the protein in patients, prompting the FDA to place a hold on the studies until the new technology is in place.

Since entering the clinic with VEGF-2 in December 1998, Vascular Genetics (Durham, N.C.) has completed enrollment and dosing in three trials, and treated the majority of