FDAnews
www.fdanews.com/articles/96311-targeted-genetics-rsquo-inflammatory-arthritis-phase-i-ii-trial-placed-on-clinical-hold

Targeted Genetics’ Inflammatory Arthritis Phase I/II Trial Placed on Clinical Hold

July 25, 2007

Targeted Genetics announced that the development program of tgAAC94, an investigational therapy for the treatment of inflammatory arthritis, has been placed on clinical hold.

According to Targeted Genetics, the FDA stopped further administration of tgAAC94 due to the uncertainty of the cause of a serious adverse event that occurred in one subject enrolled in the study.

Subjects already enrolled in the study will continue to be followed and monitored, the company said. Since the trial began in October 2005, 127 subjects have received an initial dose of active drug or placebo, and 74 subjects out of the total 127 have received a second dose of active drug, the company added.