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US gene therapy trial is to restart, despite patient’s death

BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39419.369282.DB (Published 06 December 2007) Cite this as: BMJ 2007;335:1172
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration has allowed the resumption of clinical trials of an experimental form of gene therapy for inflammatory arthritis. Trials were suspended in July when a patient died after a second injection into the knee joint of the gene based therapy developed by Targeted Genetics Corporation of Seattle, Washington.

    Targeted Genetics said in a press release that the FDA had reviewed data on safety concerning all 127 patients in the trial of the treatment, which used tgAAC94, an investigational gene therapy product developed to treat active inflammatory arthritis, as well as data from the patient who died. The investigation found that the drug did not contribute to her death, the company said.

    The Recombinant Advisory Committee of the National Institutes …

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