The bottleneck at Vascular Genetics

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 its target population in a fourth study. The company had agreed at the start of the studies to provide the agency with data on blood levels of the protein in trial participants, but has been unable to do so because it took longer than anticipated to develop a custom assay, according to President John Cumming. He added that the assay is being validated and should be available soon. ...