Patient dies during gene therapy trial

July 27, 2007

U.S. health officials say a patient died while participating in a gene therapy experiment to treat arthritis.

The precise cause of death is unknown, The Washington Post said Friday.

The Food and Drug Administration said it was informed by Targeted Genetics Corp. of Seattle the patient died while receiving an investigational gene therapy product in a clinical trial for the treatment of active inflammatory arthritis, the agency said in a release.

The FDA said it has placed the trial on clinical hold, which means no further product can be administered and no new patients can be enrolled.

The product being studied used a recombinant adeno-associated virus (AAV) derived vector. It was administered into the arthritic joint to reduce inflammation.

The company said more than 100 subjects have been enrolled in the trial, with no other known adverse effects. As a precaution, however, the FDA said it is further reviewing all ongoing trials involving any use of AAV.

Copyright 2007 by United Press International

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