Company: Fungus likely caused gene trial death

Written byAndrea Gawrylewski

| 1 min read

Targeted Genetics officials anticipate that the cause of death of a subject in their gene therapy clinical trial in July will be disseminated histoplasmosis -- a fungal infection -- and not connected to the trial drug, H. Stewart Parker, CEO of Targeted Genetics, told The Scientist. The finding will be announced at the Monday (September 17) National Institutes of Health Recombinant DNA Advisory Committee meeting. "We believe strongly that it's very unlikely that this drug had anything to do with the death," said Parker. "We have to show that as conclusively as we can" at the meeting. As we linkurl:reported;http://www.the-scientist.com/news/display/53453/ in July, one patient in a clinical trial of tgAAC94, an adeno-associated virus (AAV) vector to treat inflammatory arthritis, got sick on July 24 and died July 29. The FDA halted the trial once the adverse effect had been reported. The patient was treated at the University of Chicago Medical Center for the reaction, and the pathologist there is still processing some of the tissue samples and molecular data, according to Parker. She said it is unlikely that that data will be received in time to be presented at the Monday meeting. The autopsy was performed by the pathologist at the University of Chicago, but Targeted Genetics has not seen the report in its entirety, said Parker. "It's a major mystery," Kyle Hogarth, head of the intensive care unit at the University of Chicago Medical Center told linkurl:The Washington Post;http://www.washingtonpost.com/wp-dyn/content/article/2007/08/16/AR2007081602322.html last month. "We as well as everyone else are anxious to examine this situation and take it to its conclusion, and look at all possible data to see if we had anything remotely to do with [the patient's] death," Parker said.

Company: Fungus likely caused gene trial death

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