Targeted Genetics Corporation, a Seattle-based company specializing in molecular therapeutics, informed the U.S. Food and Drug Administration (FDA) of the death of a patient who had been receiving an investigational gene therapy product as part of a clinical trial. The patient, one of more than 100 enrolled in the trial, had been receiving the therapy for severe inflammatory arthritis. The product in the trial employs a recombinant adeno-associated viral vector to deliver the genetic material. The FDA was notified of the death on July 24, 2007. The study has been suspended while the company investigates the cause of death. eNotes will report on this story as further details become available.
Read the FDA Statement on Gene Therapy Clinical Trial.
Source: FDA news release dated July 26, 2007 and The Seattle Times July 28, 2007