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news.Targeted Genetics Corporation has initiated a phase I clinical trial of tgAAC94 administered directly to affected joints of patients with inflammatory arthritis.
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tgAAC94 utilizes Targeted Genetics’ Adeno-Associated Viral (AAV) vector technology to deliver a DNA sequence encoding an inhibitor of TNF-alpha, a potent pro-inflammatory cytokine that plays a major role in inflammatory arthritis.
This double-blinded, placebo-controlled study is designed to enroll up to 40 subjects and will evaluate tgAAC94 at two dose levels in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, who may be receiving concomitant treatments of anti-TNF-alpha therapy, but who continue to experience inflammation in one or more joints.
“Initiation of this trial is supported by the positive clinical data from the first phase I trial in arthritis patients who were not taking TNF-alpha inhibitors and which demonstrated that tgAAC94 was well tolerated and could safely be administered directly to joints,” said H. Stewart Parker, president and chief executive officer of Targeted Genetics. “This new trial will evaluate tgAAC94 in patients already receiving anti-TNF-alpha therapies and expands the patient population to include our intended treatment group.”