Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Assessment of Its Phase I/II Trial of tgAAC94 for Inflammatory...( SEATTLE Dec. 3 /- Targeted Geneti...),Health

SEATTLE, Dec. 3 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (Nasdaq: TGEN) today reported on the National Institutes of Health (NIH) Recombinant DNA Advisory Committee's (RAC) assessment of the previously reported fatal serious adverse event (SAE) in the Phase I/II trial of tgAAC94 for inflammatory arthritis.

The Committee's opinion is that the subject's death was a result of complications from an opportunistic infection, disseminated histoplasmosis, which caused the study participant to experience a retroperitoneal hematoma and multi-organ failure. Further, the RAC observed that an apparent risk factor that may have had an impact on the patient's susceptibility to the infection was the patient's longstanding systemic treatment for rheumatoid arthritis with a TNF antagonist, adalimumab. The RAC indicated there was insufficient data available to determine if the patient may have had an immune response to the local injection of tgAAC94 as a part of the clinical trial in which she was participating. The panel also observed, however, that if there was an immune response to the intra-articular injection of tgAAV94 in this patient, it was very unlikely to have been a significant contributor, if at all, to the subject's clinical course and was not the cause of her death.

On October 23, 2007, upon comprehensive review of all available data, which were also presented at the American College of Rheumatology Annual Meeting on November 10, the study's independent data safety monitoring board concluded that the SAE was not related to the tgAAC94 product. In addition, as recently reported, the U.S. Food and Drug Administration (FDA) also released the trial from clinical hold, permitting the clinical trial
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