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Whether it was the experimental arthritis drug being tested that caused the illness is not yet known. But the condition "was related in time to the receipt of a second injection of the product," the U.S. Food and Drug Administration said Thursday in a statement. The agency is investigating whether the illness was related to the treatment.
The FDA said it was informed about the death of the patient on Tuesday, the same day Targeted Genetic announced the interruption of the clinical trial in the wake of an "adverse event" for a patient. "We are deeply saddened by the death of an individual enrolled in our clinical trial," Chief Executive H. Stewart Parker said Thursday in a statement. She added that the patient's clinical symptoms have "to our knowledge, never been seen" as a consequence of the gene therapy used in the trial. Neither the company nor the agency said how the patient died. "We do not yet understand the cause of death," said Barrie Carter, Targeted Genetics' chief scientific officer. Some 127 patients have received an initial dose of the active drug or placebo, including 74 that received a second dose of the drug, Targeted Genetics said. The drug, known as tgAAC94, is designed to be used along with other therapies. The tgAAC94 is an AAV loaded with a TNFR:Fc chimera that is designed to be over-expressed and soak up TNFalpha, thus reducing any inflammatory cascade. For the trial, there are about 20 testing sites across the U.S., Carter said. The FDA said it does not know of similar illnesses in other gene-therapy trials, but as a precaution, the agency will take a closer look at all ongoing experiments of that type. Analysts have said that it's too early to know whether the illness is related to the drug, and that the drug could still be viable. But shares of the Seattle-based biotechnology company fell more than 20 percent on the day following its announcement that the trial was suspended. Yesterday's news that the patient had died came after the market close. On Thursday, the stock closed at $2.07, down 3 cents or 1.43 percent. Targeted Genetics, which currently doesn't market any drugs, is also working on therapies for human immunodeficiency virus, congestive heart failure and Huntington's disease
Message posted by: Simon Chandler
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