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news.Targeted Genetics has received approval from the FDA to amend the clinical protocol of its ongoing phase I trial of tgAAC94 in patients with inflammatory arthritis.
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The amended protocol now includes a higher dose and increases the number of patients targeted for enrollment from 40 to 120. Under the amended protocol, the study is now designated a phase I/II trial.
Although the primary objective is safety, the increase in patient numbers and the exploration of additional secondary efficacy endpoints has warranted the trial designation upgrade from phase I to phase I/II.
“We are very excited about the progress we are making in our inflammatory arthritis program,” said H Stewart Parker, president and CEO of Targeted Genetics. “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.”