The study is designed to assess the safety and potential efficacy of different doses of the drug, tgAAC94, administered directly to affected joints of patients with inflammatory arthritis. The therapy utilizes an adeno-associated virus vector to deliver the gene encoding a soluble form of the receptor for TNF-alpha, a key mediator of inflammation.
In the trial, 120 adults were randomized into three dose levels to receive a single intra-articular injection of either tgAAC94 or placebo into the knee, ankle, wrist, metacarpophalangeal or elbow, followed by an open-label injection of tgAAC94 after 12 to 30 weeks, depending on when arthritis symptoms in the target joint meet criteria for re-injection. Following the second injection, all subjects are followed for an additional 30 weeks.
Interim data suggest that treatment with tgAAC94 may lead to improvements in signs and symptoms of arthritis in injected joints, Targeted Genetics said.
H Stewart Parker, president and CEO of Targeted Genetics, said: “Completing enrollment and initial dosing in this trial is an important step in the development of tgAAC94. We expect to present additional interim data from the trial at multiple scientific venues during 2007, and data from the completed study in mid-2008.”