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Onyx Pharmaceuticals Initiates Phase 1 Study of Oral Proteasome Inhibitor in Advanced Solid Tumors
Date:6/1/2010

EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the initiation of a Phase 1 study of ONX 0912, an oral proteasome inhibitor, in patients with advanced refractory or recurrent solid tumors.

"Based on insights gained from our ongoing carfilzomib development program and ONX 0912's favorable preclinical profile – anti-tumor activity, safety and biodistribution – we believe ONX 0912 may have the potential to expand the use of proteasome inhibitors in the treatment of cancer," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx Pharmaceuticals.  "As an orally-dosed agent, ONX 0912 is designed to provide prolonged proteasome inhibition and easy combinability with other orally available therapies."  

Trial Design

This multicenter, open-label, dose-escalation study is evaluating the safety and tolerability of ONX 0912 in up to 50 patients with advanced refractory or recurrent solid tumor malignancies for which standard curative measures do not exist or are no longer effective.  The trial will determine the maximum tolerated dose (MTD), dose limiting toxicities, and pharmacokinetics/pharmacodynamics of ONX 0912 when administered orally on days 1 through 5 of a 14-day cycle.  Cohorts of 3 to 6 patients will receive ONX 0912 at escalating doses, starting at 30 mg, until MTD is determined.  Treatment will be repeated in 14-day cycles. The trial will be conducted in the United States.

About Onyx's Proteasome Inhibitor Development Program


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SOURCE Onyx Pharmaceuticals, Inc.
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