Ph I/II US trial of tgACC94 resumes

USA-based Targeted Genetics Corp says that the Food and Drug Administration has removed the hold on a Phase I/II clinical trial of tgACC94, its drug candidate for inflammatory arthritis. This follows a review of the safety data on all 127 subjects and all findings from a fatal serious adverse event, which led to a clinical hold in July.

According to the firm, the data obtained during the investigation indicates that tgAAC94 did not contribute to the patient's death, which was due to disseminated histoplasmosis. Final molecular test results supported initial observations that no amplification of viral vector occurred in the patient's body as a result of the investigational therapy, that only trace amounts of vector DNA were detected in tissues outside the treated joint, and that the amount of circulating tumor necrosis factor-alpha antagonist protein was as expected from the background therapy. The subject was on adalimumab, methotrexate and prednisone, which are known to be immunosuppressive and a risk factor for histoplasma infection.

"We are working closely with trial site physicians to ensure we resume development in the most efficient manner possible with patient safety, as always, of paramount importance," said Stewart Parker, chief executive of Targeted Genetics. "We anticipate having full data from the Phase I/II trial in the second half of 2008. In the meantime, we believe we have the information needed from this trial to simultaneously plan initiation of a Phase II trial of tgACC94 in the second half of 2008," he added.