US firm Targeted Genetics has presented interim data from its ongoing Phase I/II trial of tgAAC94 in patients with inflammatory arthritis at the American Society of Gene Therapy (ASGT) 2006 Annual Meeting. Pervin Anklesaria, the firm's vice president, therapeutic development, highlighted initial data from the study and a summary of the recently completed Phase I clinical trials of tgAAC94.
tgAAC94 utilizes an adeno-associated virus vector to deliver the gene encoding a soluble form of the receptor for tumor necrosis factor-alpha directly to affected joints. TNFR:Fc protein is a potent inhibitor of tumor necrosis factor alpha, a key mediator of inflammation.
Preliminary data indicate tgAAC94 is safe and well-tolerated at doses of up to 5x10(12) particles (DRP) /mL in subjects with and without systemic TNF-alpha antagonists. Data from the first cohort of subjects treated with doses of 1x10(11) (DRP)/mL of joint volume demonstrate a trend toward sustained improvement in tenderness and swelling in treated joints, compared to placebo. Additionally, fewer patients receiving tgAAC94 had symptoms requiring re-injection at the 12-week time point, compared with patients in the placebo arm. Although the numbers are small, the data also suggest a trend toward greater responses to tgAAC94 in patients taking systemic TNF-alpha antagonist therapy compared with patients not on these therapies.
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