Athenex Announces Positive Recommendation by the Drug Safety Monitoring Board Upon the Second Interim Analysis and to Continue the Oraxol Phase III Program
The Oraxol 001 Phase III Clinical Trial is a randomized controlled clinical trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer. The study is designed to compare the safety and demonstrate the superiority of Oraxol over IV paclitaxel. Clinical activity is based on confirmed response rate as assessed by RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. Assessment of tumors scans are made by a blinded independent radiologic imaging analysis center.
Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, “After review of the efficacy and safety data of this Oraxol Phase III clinical trial, the unanimous recommendation by the DSMB to continue this study represents the achievement of another critical milestone for Oraxol. We plan to provide these confidential unblinded data to regulatory authorities soon to discuss the marketing submission pathways. In the mean time, we will continue to rapidly advance this clinical trial.”
About Athenex, Inc.
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. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery based on non-absorbed P-glycoprotein inhibitor, (2) Src Kinase Inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) metabolic manipulation of cancer. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, which is able to facilitate oral absorption of traditional cytotoxics, which
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