4 December 2007
A US gene therapy trial of a treatment for active inflammatory arthritis (including rheumatoid arthritis) has been given permission to resume after a Food and Drug Administration (FDA) hearing concluded that the death of a trial participant in July this year (see previous news) was due to a fungal infection completely unrelated to the gene therapy. There was concern that the immunosuppression induced by the delivery of the therapeutic DNA (encoding the TNF-alpha receptor), in combination with the subject’s current arthritis medication, might have contributed to the death, and the trial was suspended while investigations were carried out.
A meeting of the federal Recombinant DNA Advisory Committee (RAC) held on 3rd December at the National Institutes of Health (NIH) has reviewed the death and also concluded that it was unrelated to the gene therapy treatment, but suggested that the design of the study is altered slightly, to include more haematological monitoring of participants and greater care to exclude any with signs of current infection or a history of opportunistic infections for treatment. They also noted that more information should be sought on the potential effect of immunosuppressant drug treatment on risk.
The phase I/II clinical trial will continue with some modifications; of the 35/127 patients due to receive a second dose of the gene therapy agent, all will be informed of the death of the trial participant and any with a raised temperature will not receive the therapeutic (see press release).