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U.S. Department of Health and Human Services

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FDA Releases Statement on Gene Therapy Trial

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On July 24, 2007, Targeted Genetics Corporation informed FDA about the death of a patient who received an investigational gene therapy product. The product was being tested in a clinical trial as a treatment for active inflammatory arthritis. FDA's condolences go to the patient's family.

The Seattle firm notified FDA earlier that a patient in the trial experienced a serious adverse event. Although the cause of illness wasn't known, and is still uncertain, FDA immediately placed the trial on clinical hold.

The product in the trial uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector, derived from a recombinant adeno-associated virus (AAV), delivers the gene for Tumor-Necrosis Factor -Receptor.  The gene therapy was administered into patients' joints to reduce inflammation.

According to the company, more than 100 subjects have been enrolled in the trial without known similar serious events. However, the patient's illness was related in time to the receipt of a second injection of the product.

Targeted Genetics is cooperating with FDA's investigation, and has agreed to give the agency information that may help determine the cause of this patient's death. FDA is also coordinating with the National Institutes of Health to better understand the potential scientific and safety implications of this event.

Although FDA is not aware of similar adverse events occurring in other gene therapy trials, the agency is reviewing all ongoing trials involving any use of AAV as a precaution.

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This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: July 27, 2007