Targeted Genetics interim study data says tgAAC94 improves arthritis symptoms

By Angela McDaniels

Seattle, June 1 - Targeted Genetics Corp. said interim data from its ongoing phase 1/ 2 trial of tgAAC94 in patients with inflammatory arthritis demonstrates a trend toward sustained improvement in tenderness and swelling in the joints of patients who received the drug candidate, compared to those who received a placebo.

The data also indicates that 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.

"We have observed very favorable safety and toxicity profiles at the first two dose levels and have seen trends toward improvement. The data suggest that a single, intra-articular injection of tgAAC94 resulted in measurable and sustained reductions in pain and swelling," lead investigator Philip Mease of Seattle's Swedish Hospital Medical Center said in a company news release.

"Given the number of inflammatory arthritis patients who still experience unresolved symptoms despite treatment with systemic TNF-alpha antagonist therapy, there is a compelling need to explore additional approaches to treatment, and we believe that tgAAC94 may have significant potential in improving the long-term management of this disease."

The company will present data and additional details of the trial design at the American Society of Gene Therapy 2006 Annual Meeting, which is being held in Baltimore from June 1 to June 5.

In the ongoing study, 40 adults were 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. The study will enroll a total of 120 adults.

tgAAC94 is being developed as a potential supplement to systemic anti-TNF-alpha protein therapy for use in patients with inflammatory arthritis who have one or more joints that do not respond to systemic protein therapy, according to the release.

The product candidate uses an adeno-associated virus vector to deliver a DNA sequence that encodes a soluble form of the receptor for tumor necrosis factor-alpha (TNFR:Fc) directly to affected joints. TNFR:Fc protein inhibits tumor necrosis factor alpha, a key mediator of inflammation.

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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