On January 9, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule (Press release, Athenex, JAN 9, 2019, View Source;p=RssLanding&cat=news&id=2382773 [SID1234532606]). Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.
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About Oraxol Phase III Study
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