The FDA has not revealed cause of death or any details about the patient who passed away while a member of the gene therapy trial by Targeted Genetics Corp. However, the FDA has confirmed it is launching an investigation into the health and safety of 28 others involved in the study. The FDA said it was investigating if the gene therapy played any role in the death of the patient, which occurred Tuesday.
According to FDA, this patient became ill after a second injection of the therapy directly into an arthritic joint. The therapy uses adeno-associated virus or AAV to deliver a gene that in turn blocks tumor necrosis factor (TNF). Adenoviruses are a group that typically cause respiratory illnesses such as colds.
While drugs that block TNF already are widely used to treat rheumatoid arthritis and other conditions, this is the first study to use gene therapy.
Gene therapy has come under fire lately as this death marks the third fatality in the field since 1999 when 18-year-old Jesse Gelsinger died in his fourth day of a gene therapy experiment at the University of Pennsylvania.
According to AP reports, there have been no reports so far by the FDA of any serious side effects in any of those studies but, the agency is now reviewing all the projects still actively treating patients.
The incident will be discussed at a September meeting of a National Institutes of Health advisory panel where the regulators plan to discuss its potential scientific implications.
