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Targeted Genetics ups dose, target enrollment for tgAAC94 arthritis trial
By Lisa Kerner
Erie, Pa., March 16 - Targeted Genetics Corp. said it has received approval from the Food and Drug Administration to amend the clinical protocol of its ongoing phase 1 trial of tgAAC94 in patients with inflammatory arthritis.
Under the amended protocol, the study is now a phase 1/2 trial. The amended protocol also includes a higher dose and increases the number of patients targeted for enrollment to 120 from 40, according to a company news release.
"The amended protocol allows us to obtain the data necessary to establish efficacy endpoints for additional clinical trials, determine a treatment effect and, ultimately, lay the foundation for commercialization of the first gene therapeutic for rheumatoid arthritis," president and chief executive officer H. Stewart Parker said in the release
The primary endpoint of the study is to establish the safety of higher doses and of repeat administration of tgAAC94 into the joints of patients with and without concomitant TNF-alpha inhibitor therapy, according to the release.
Secondary endpoints include evaluation of pain, swelling, duration of response and overall disease activity following intra-articular administration of tgAAC94 to affected joints.
In the original double-blinded, placebo-controlled phase 1 study, two dose levels of tgAAC94 were administered in up to 40 patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.
tgAAC94 is being developed as a potential supplement to systemic anti-TNF-alpha protein therapy for use in patients with inflammatory arthritis.
Targeted Genetics is a biotechnology company that develops and commercializes targeted molecular therapies for inflammatory arthritis, HIV/AIDS and other acquired and inherited diseases with significant unmet medical need.
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