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news.Anadys Pharmaceuticals has commenced patient dosing in a Phase I study of ANA773, the company's oral TLR7 agonist prodrug, in patients with advanced solid tumors.
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The Phase I trial, a multiple, ascending dose study conducted at several sites in the US is designed to identify pharmacologically active doses and preliminary antitumor activity as well as to select the dose and schedule for Phase II trials. In addition to safety and tolerability, patients will be monitored for pharmacodynamic responses indicative of immunological stimulation. Initially, patients will be dosed every other day. The company also expects to investigate additional schedules during this first clinical trial and anticipates that up to 60 patients will be enrolled in the study.
Steve Worland, president and CEO of Anadys, said: “The initiation of this trial marks the resumption of our clinical investigation of oral TLR7 agonists and moves us closer toward our objective of developing ANA773 as a novel therapy for patients with cancer.”