Targeted Genetics Corp., a downtown Seattle biotech , and the FDA yesterday revealed that one of TGC's gene-therapy patients has died. The FDA has now

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Experimental-Drug Death

FDA halts Seattle arthritis study.

Targeted Genetics Corp., a downtown Seattle biotech, and the FDA yesterday revealed that one of TGC's gene-therapy patients has died. The FDA has now halted the firm's study of a drug that could be used to treat inflammatory arthritis, and is reviewing programs involving similar experimental drug testing at other U.S. companies. The drug, clinically known as tgAAC94, was injected directly to affected joints of study subjects with inflammatory arthritis, TGC said. Only sketchy details have been released, but in a statement, TGC says the trial was halted a few days earlier "as a precautionary measure after the occurrence of a Serious Adverse Event (SAE) in one subject. The individual who experienced this SAE has subsequently died." Others enrolled in the trial will continue to be monitored. "The investigation into the cause of the patient's illness and subsequent death is intensive and ongoing," an FDA statement says. The trial was launched in October 2005; since then, 127 subjects have received an initial dose of the drug or a placebo, while others were given two injections. The patient who died received two doses, the FDA said.

 
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