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news.The FDA has removed the hold on Targeted Genetics Corporation's Phase I/II clinical trial of tgACC94 for inflammatory arthritis. This action follows the agency's review of the safety data to date on all 127 subjects and all data from a fatal serious adverse event, which led to a clinical trial hold in July 2007.
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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 also 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 TNF-alpha antagonist protein was as expected from the background therapy.
Targeted Genetics is revising the Phase I/II trial’s informed consent to include information about the serious adverse event, and will amend the protocol to encompass suggestions made by the FDA and its independent data safety monitoring board.
Stewart Parker, president and CEO of Targeted Genetics, said: “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. 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.”