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Anadys Pharmaceuticals Commences Phase I Clinical Trial of ANA773 in Cancer Patients
Date:2/28/2008

SAN DIEGO, Feb. 28 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that patient dosing has commenced in a Phase I study of ANA773, the company's oral TLR7 agonist prodrug, in patients with advanced solid tumors. This first-in-human trial is a safety and tolerability study designed to identify pharmacologically active doses and preliminary antitumor activity as well as to select the dose and schedule for Phase II trials.

The Phase I trial is a multiple, ascending dose study conducted at several sites in the United States. 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.

"The extensive preclinical investigation Anadys has conducted with ANA773 over the last 18 months has taught us much about the pharmacology of orally administered TLR7 agonists, including the importance of schedule in sculpting the profile of immune activation," said James Freddo, M.D., Anadys' Chief Medical Officer. "We believe ANA773 holds promise for the treatment of a range of malignancies and may have utility when combined with targeted agents, therapeutic antibodies and/or chemotherapy. We are excited about having initiated this first clinical study."

Steve Worland, Ph.D., Anadys' President and Chief Executive Officer, said, "This is an important milestone for Anadys. The initiation of this trial marks the resumption of our clinical investigation of oral TLR7 agonists and moves us closer toward our objective of
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SOURCE Anadys Pharmaceuticals, Inc.
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