Targeted Genetics: interim data supports safety, tolerability of tgAAC94 in inflammatory arthritis

By Lisa Kerner

Charlotte, N.C., June 22 - Targeted Genetics Corp. said interim data from its phase 1 and ongoing phase 1/ 2 trial of tgAAC94 in patients with inflammatory arthritis support the safety and tolerability of intra-articular administration of tgAAC94 to affected joints.

The data also suggest that tgAAC94 may lead to improvements in signs and symptoms of arthritis in injected joints.

The data was presented by principal investigator Philip Mease at the Annual European Congress of Rheumatology in Amsterdam.

In the phase 1 study, 12 females and two males with rheumatoid arthritis and one male with ankylosing spondylitis received an injection into the knee or ankle, with a 24-week follow up period. Subjects receiving the higher dose of tgAAC94 had the most improvement in composite tenderness and swelling scores, the company said.

About 120 adults in the ongoing phase 1/ 2 study 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. Fewer patients receiving tgAAC94 had symptoms requiring re-injection at the 12-week time point, compared with patients in the placebo arm.

"Although the number of patients evaluated thus far is relatively small, these data are very encouraging and suggest positive response trends," Mease said in the release.

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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