Athenex Announces Completion of Target Enrollment in Phase III Study


Athenex, Inc. recently announced that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule. Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.

 Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol Phase III study is an open-label, randomized, multicenter study to determine the safety, tolerability, and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer, with a target enrollment of 360 adult female patients. Secondary endpoints will measure progression-free survival and overall survival. More information about this study is available at www.clinicaltrials.gov.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

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. 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) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, NY; Cranford, NJ; Houston, TX; Chicago, IL; Hong Kong; Taipei, Taiwan; and multiple locations in Chongqing, China. For more information, visit www.athenex.com.