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The Oraxol Phase III clinical study (KX-ORAX-001) is a randomized controlled international clinical trial investigating the superiority of Oraxol over intravenous (“IV”) paclitaxel in the treatment of patients with metastatic breast cancer. The primary endpoint is confirmed tumor response rate assessed by a blinded independent radiologic imaging analysis center using the RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. The study has a target sample size of 360 patients. The study has completed the first of two planned interim analyses. The second interim analysis based on 180 evaluable patients is planned for the middle of 2018. The positive US FDA feedback would allow an Oraxol US registration submission upon successful completion of this single Phase III study.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. The Company’s current clinical pipeline is derived from two different platform technologies: Athenex’s Orascovery and Src Kinase Inhibition platforms. Part of the Orascovery platform is
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Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; need to raise additional capital; competition; intellectual property risks; risks relating to doing business in