WASHINGTON — The Food and Drug Administration has given a Seattle company permission to resume its human tests of an experimental, gene- based arthritis treatment whose safety came into question last summer after a 36-year-old study participant died.
Although a final report from outside investigators will not be made public until Dec. 3, the regulatory agency has concluded that the death was not related to the treatment, said a spokeswoman for the company, Targeted Genetics.
As many as 35 patients are still eligible to get one more injection of the experimental product, spokeswoman Stacie Byars said, adding that the company recognizes that some may opt out.
Jolee Mohr of Taylorville, Ill., died July 24, about three weeks after getting trillions of genetically engineered viruses injected into her right knee. She became ill the day she got that injection, eventually dying of a fungal infection and massive internal bleeding.
But investigations by company scientists, a National Institutes of Health expert panel and doctors at the University of Chicago found no evidence that the treatment was at fault.
