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FDA suspends Seattle company's gene therapy study after patient's death

A Seattle-based company's gene therapy study for advanced arthritis was suspended this week, and 28 others around the country are pending review, following the death of a patient on Tuesday.

A Seattle-based company's gene therapy study for advanced arthritis was suspended this week, and 28 others around the country are pending review, following the death of a patient on Tuesday.

Targeted Genetics Corp notified the Food and Drug Administration (FDA) of the patient's illness and subsequent death after receiving a second injection of the therapy comprising adeno-associated virus or AAV. AAV delivers a gene that blocks tumour necrosis factor (TNF) - the substance that causes joint inflammation associated with crippling forms of arthritis. Drugs that block TNF are widely used to treat rheumatoid arthritis and other conditions, but the use of it in gene therapy is new. More than 100 people were enrolled in the study; but no others experienced any problems as a result of their involvement. 

Twenty-eight other gene therapy studies that used, or are using, the same AAV virus have been reported to the FDA. The FDA said on Thursday that it was not aware of any serious side effects resulting from any of these studies, but that as a precaution, officials were reviewing all those that were still actively treating patients.

Regulators are taking this latest death very seriously, and the National Institutes of Health's advisory committee on gene therapy will meet in September to discuss the potential scientific implications of this case.
 

30th September 2008

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