Targeted Genetics releases promising arthritis drug data

The compound, tgAAC94, is an investigational therapeutic designed to inhibit the activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation. The phase I/II study is designed to assess the safety and potential effect of different doses of tgAAC94 administered directly to affected joints of subjects with inflammatory arthritis with or without concurrent use of systemic TNF antagonist therapies.

In the dose escalation portion of the study, three cohorts of 20 subjects were randomized to receive tgAAC94 or placebo. At week 12 after treatment with tgAAC94, 13%, 14% and 33% of subjects receiving low, mid and high dose tgAAC94, respectively, achieved a two-point reduction in swelling compared to none in the placebo group. A trend in reduction of swelling in tgAAC94-injected joints compared to placebo was also observed in subjects with or without concurrent use of systemic TNF antagonist.

Patients randomized in the second segment (cohorts 4 to 6) of this phase I/II study are currently being followed for safety and improvement in swelling of injected joints as well as additional measures aimed to assess functional improvement in treated joints. These data will guide further clinical development and design of the subsequent phase II study. The company expects to present additional data from the study in the second half of 2007, with complete results anticipated in mid-2008.

H Stewart Parker, president and CEO of Targeted Genetics, said: “We believe that tgAAC94 has significant potential to address disease that remains refractory to approved therapies, and are encouraged by the data suggesting that tgAAC94 can reduce signs and symptoms of inflammatory arthritis.”