Targeted Genetics reports tgAAC94 reduces swelling, tenderness in inflammatory arthritis

New York, June 5 - Targeted Genetics Corp. said preliminary data from its ongoing phase 1/2 trial of tgAAC94 in patients with inflammatory arthritis indicated the treatment reduced tenderness and swelling.

Preliminary data indicates tgAAC94 is safe and well-tolerated at doses of up to 5x10(12) particles (DRP)/mL in subjects with and without systemic tumor necrosis factor-alpha antagonists, the company said.

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 a 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 tumor necrosis factor-alpha antagonist therapy compared with patients not on these therapies, Targeted Genetics said.

The data was reported at the American Society of Gene Therapy annual meeting.

tgAAC94 utilizes an adeno-associated virus vector to deliver directly to affected joints the gene encoding a soluble form of the receptor for tumor necrosis factor-alpha.

In the ongoing study, approximately 120 adults are being randomized into three dose groups to receive a single intra-articular injection of either tgAAC94 or a placebo, followed by an open-label injection of tgAAC94 after 12 to 30 weeks, depending on when swelling in the target joint meets criteria for re-injection.

So far 40 patients have been treated.

Seattle-based Targeted Genetics develops targeted molecular therapies for the prevention and treatment of inflammatory arthritis, HIV/AIDS and other acquired and inherited diseases.

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