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Targeted Genetics Reports Inflammatory Arthritis Clinical Data at,European Rheumatology Conference

the additional cohorts in this study would provide an important advance in our understanding of how to manage inflammatory arthritis, a chronic and often debilitating disease."

In the dose escalation portion of the study, three cohorts of 20 subjects were randomized to receive tgAAC94 (n = 15) or placebo (n = 5). Aggregate data on the primary and secondary end-points from the first 61 subjects support the safety and tolerability of single and repeat intra-articular injections of tgAAC94 to affected joints at doses up to 1x10(13) DNase Resistant Particles per milli-liter (DRP/mL) of joint volume in subjects with and without systemic TNF-alpha antagonists. At week 12 after treatment with tgAAC94, 13%, 14% and 33% of subjects receiving low, mid and high dose tgAAC94, respectively, achieved a two-point reduction in swelling compared to none in the placebo group. A trend in reduction of swelling in tgAAC94-injected joints compared to placebo was also observed in subjects with or without concurrent use of systemic TNF antagonist.

For each of the cohorts, all subjects receive a dose of tgAAC94 at 12 weeks or later after first injection. The criteria for timing of the second injection are: no improvement in swelling 12 weeks after first injection; swelling returns to baseline levels after an initial improvement 12 or more weeks after first injection; or more than 30 weeks have passed since first injection. According to these criteria, a similar proportion of subjects did not need the second injection prior to week 30 in all dose groups and placebo. Following the second injection, subjects are followed for an additional 30 weeks.

"These data are very encouraging and suggest that tgAAC94 has the potential to address the unmet medical needs of a significant number of inflammatory arthritis patients," said H. Stewart Parker, president and chief executive officer of Targeted Genetics. "Moreover, these results demonstrate the feasibility of using our AAV pla
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