FDA Removes Hold on TgAAC94 Trial

The FDA has lifted its hold on Targeted Genetics’ Phase I/II trial of tgAAC94 for inflammatory arthritis.

The action follows the agency’s review of the safety data on all 127 subjects and from a fatal serious adverse event, which led to the hold in July.

The data indicates tgAAC94 did not contribute to the patient’s death, which was due to disseminated histoplasmosis. The subject was on adalimumab, methotrexate and prednisone, which are known to be immunosuppressive and a risk factor for histoplasma infection, Targeted Genetics said.

The company will revise the Phase I/II trial’s informed consent to include information about the serious adverse event. It also will amend the protocol to include suggestions made by the FDA and its independent data safety monitoring board.