Reuters reported this week that a patient who became ill following two experimental gene therapy injections for arthritis has died. U.S. health regulators are investigating the cause, officials said yesterday. The gene therapy trial by Targeted Genetics Corp. was placed on hold before the death, after the patient suffered a serious, unidentified health problem.
The hold means that no one else can receive the treatment, called tgAAC94, and no new patients can be enrolled in the study, the Food and Drug Administration said.
The company and the FDA said they were working to determine the cause of the death. "The investigation into the cause of the patient's illness and subsequent death is intensive and ongoing," an FDA statement said.
Gene therapy is being pursued by a number of biopharma companies including Genzyme. Michele Vaccarello took a look at the company's plans in this recent article.
