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FDA halts gene study after death of patient

July 27, 2007|From the Associated Press

WASHINGTON — The government has suspended a Seattle company's gene therapy study -- and is reviewing the safety of 28 others around the country -- after learning that a patient died this week.

The Food and Drug Administration didn't reveal the cause of death or any details about the patient, who had enrolled in a study of gene therapy for advanced arthritis.

The agency said it was investigating what role, if any, therapy played in the death, which occurred Tuesday.

Twenty-eight other gene therapy studies have been reported to the FDA that used, or are using, the same virus, called adeno-associated virus or AAV.

The FDA said Thursday that it was not aware of any serious side effects in any of those studies, but that as a precaution, officials were reviewing all the ones still actively treating patients.

Targeted Genetics Corp. notified the FDA of the patient's illness and subsequent death.

The company had enrolled more than 100 people in the study without similar problems, but this patient became ill after a second injection of the therapy directly into an arthritic joint, the FDA said.

The therapy uses AAV to deliver a gene that in turn blocks tumor necrosis factor, a substance that fuels the joint inflammation behind crippling forms of arthritis. Drugs that block TNF already are widely used to treat rheumatoid arthritis and other conditions, but a gene therapy approach is novel.

"We are deeply saddened by the death of an individual enrolled in our clinical trial," company president H. Stewart Parker said in a statement issued Thursday.

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