Patient death leads FDA to suspend gene therapy study.(Drug Safety)(Food and Drug Administration)

From: Adverse Event Reporting News | Date: July 30, 2007 | Copyright information

FDA has suspended a Seattle company's gene therapy study after learning that a patient died, The Associated Press (AP) reported July 26.

Targeted Genetics, which notified FDA of the patient's illness and subsequent death, had enrolled more than 100 people in a study of gene therapy for advanced arthritis without similar problems. This patient became ill after a second injection of the therapy directly into an arthritic joint, FDA said.

FDA said it was investigating what role, if any, therapy played in the death, which occurred July 24. The agency didn't reveal the cause ...

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