Astellas has reported a fourth death in its clinical trial of the gene therapy for the rare disease X-linked myotubular myopathy. The gene therapy AT132 uses AAV8 mediated delivery (I incorrectly identified the vector as AAV5 in a post in August last year).
The trial had previously been halted by the FDA following the deaths, linked to liver damage, of three trial participants who had pre-existing liver conditions and who had received a higher dose of the gene therapy. The trial halt was only lifted last December by the FDA after Astellas agreed to continue dosing at a dose that contained less than half the vector genomes per kilogram of body weight of the high dose. Of particular concern is that the latest death occurred in a child (the first and only participant since the trial reopened) whose liver appeared normal on an ultrasound at the time of enrolment and who had received the lower dose.
Once more, the FDA has called a halt to the AT132 trial.
https://pharmaphorum.com/news/astel...tm_campaign=Feed: pharmaphorum (pharmaphorum)
https://www.fiercebiotech.com/biote...-audentes-buy-as-fda-slaps-clinical-hold-test
https://hotcopper.com.au/threads/co...5969206/page-29?post_id=55768055#.YUEXkZ1LiUk
https://hotcopper.com.au/threads/an...5566385/page-11?post_id=46735838#.YUEX4J1LiUk
Astellas has reported a fourth death in its clinical trial of...
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