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Experimental drug shows promise against inflammatory arthritis

At four weeks follow-up, nine of 11 patients treated with tgAAC94 showed sustained improvement in disease signs and symptoms.

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Preliminary results of a phase 1 study show an experimental drug is well tolerated by patients with inflammatory arthritis when injected directly into disease-affected joints.

The study evaluated the safety and efficacy of intra-articular injections of tgAAC94 (Targeted Genetics Corp.) in patients not using concomitant systemic tumor necrosis factor-alpha (TNF-a) antagonist therapy. TgAAC94 is a modified adeno-associated virus (AAV) designed to deliver a DNA sequence encoding for TNFR:Fc to cells within arthritic joints. TNFR:Fc is a potent inhibitor of TNF-a, which has been shown to be a key mediator of inflammation and tissue damage, according to the company.

Philip J. Mease, MD, chief of the rheumatology clinical research division at the Swedish Hospital Medical Center in Seattle, conducted the trial with colleagues in the United States and Canada. The researchers randomly assigned 15 patients to receive one of two escalating doses of tgAAC94 (11 patients) or placebo (four patients). They included the placebo group primarily to evaluate whether any possible adverse events that might develop resulted from the injections alone or from tgAAC94, according to a press release.

The researchers found that patients tolerated tgAAC94 injections at doses up to 1x10(11) DRP per mL of joint volume. The preliminary data also suggest the drug can produce improvements in arthritis symptoms, company officials noted in the release.

At four weeks follow-up, nine of 11 patients treated with tgAAC94 showed sustained improvement in both arthritis signs and symptoms. Seven out of nine treated patients evaluated at eight weeks follow-up also showed sustained improvement.

Only two of the four placebo-treated patients showed such improvements, according to the press release.

“Though the patient numbers are relatively small and the study is not powered to show efficacy, I am encouraged that delivery of tgAAC94 directly into affected joints appears to be safe and has the potential to reduce signs and symptoms of arthritis,” Mease said.

Investigators will continue patient follow-up out to 24 weeks, although enrollment in the trial has been closed.

Based on the results, the company plans to continue clinical development and initiate a new trial involving patients concurrently receiving systemic anti-TNF therapies but continue to suffer from affected joints. “We expect to begin the next clinical trial of tgAAC94 in the third quarter of this year,” H. Stewart Parker, president and chief executive officer of Targeted Genetics, said in the release.

For more information:

• Targeted Genetics Corp.; Web site: www.targen.com.