TARGETED GENETICS EXPANDS INFLAMMATORY ARTHRITIS TRIAL

Targeted Genetics has received approval from the FDA to amend the clinical protocol of its ongoing Phase I trial of tgAAC94 in patients with inflammatory arthritis. The amended protocol now includes a higher dose and increases the number of patients targeted for enrollment from 40 to 120. Under the amended protocol, the study is now designated a Phase I/II trial.

Although the primary objective is safety, the increase in patient numbers and the exploration of additional secondary efficacy endpoints has warranted the trial designation upgrade from Phase I to Phase I/II.