Targeted Genetics clinical hold following patient death
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA places clinical hold on Targeted Genetics' gene therapy trial with tgAAC94 for the treatment of inflammatory arthritis following the death of a 36-year-old woman, the biotech announces July 24. The biologic uses a recombinant adeno-associated virus (AAV) derived vector to deliver a gene encoding the protein TNFR:fc, a soluble form of the tumor necrosis factor alpha receptor, to reduce inflammation and disease in patients with active inflammatory arthritis. Since the trial began in October 2005, 127 subjects have received an initial dose of active drug or placebo, and an additional 74 subjects received a second dose of active drug, according to Targeted Genetics...