Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid...( SEATTLE Sept. 17 /- Targeted Gene...),Health

SEATTLE, Sept. 17 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation (Nasdaq: TGEN) today reported on the public hearing conducted by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which reviewed the serious adverse event reported by Targeted Genetics surrounding the death of a patient participating in the Company's Phase I/II trial of tgAAC94 for inflammatory arthritis.

The clinical case was presented for the first time in a comprehensive manner and showed that histoplasmosis played a significant role in the cause of the patient's death. Initial molecular tests showed there was no replication of vector and only trace amounts of vector DNA in tissues outside the joint. Consequently, these data suggest it is unlikely that tgAAC94 contributed to the conditions that caused the death. Molecular tests are being conducted in remaining tissues and Targeted Genetics will continue to collaboratively work with academic colleagues, RAC, FDA and other involved parties to complete the investigation.

"While additional tests are needed to draw final conclusions, we believe the results to date are consistent with preclinical and clinical findings that indicate the level of vector that is present outside the locally treated area is insufficient to have further exacerbated an infection," said H. Stewart Parker, president and chief executive officer of Targeted Genetics.

Barrie J. Carter, Ph.D., executive vice president and chief scientific officer of Targeted Genetics added, "A gene therapy approach may have enormous potential to improve the treatment of rheumatoid arthritis, a disease that leads to profound morbidity and premature mortality. It is critical that we let the clini
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