The company were keen to find out whether patients displayed any adverse reaction to tgAAC94 being injected locally into the joints, and are encouraged to have found that the drug and process were well tolerated by patients. Patients also showed some signs of improvement in the signs of arthritis in the treated joints.
The preliminary data indicate that seven out of nine patients who received tgAAC94, and who have been evaluated through week eight following treatment, experienced sustained improvement in signs and symptoms of disease. In those subjects receiving placebo, improvements in arthritis signs were noted in two out of four subjects.
In the multi-center trial, conducted in the US and Canada, fifteen patients who enrolled in the trial were randomized to receive either one of two escalating dose levels of tgAAC94 or a placebo.
H Stewart Parker, president and CEO of Targeted Genetics, said, “Based on the results of this trial, we expect to advance the development of tgAAC94 into the next stage of clinical development; including localized treatment of patients who are concurrently receiving systemic anti-TNF therapies, but who continue to suffer from one or more affected joints. We expect to begin the next clinical trial of tgAAC94 in the third quarter of this year.”
The progress of patients will continue to be monitored for 24 weeks after the injection.