On September 5, 2018 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 the planned second interim analysis of the Oraxol 001 Phase III Clinical Trial in metastatic breast cancer has been conducted and reviewed by an independent Drug Safety Monitoring Board (DSMB) (Press release, Athenex, SEP 5, 2018, View Source;p=RssLanding&cat=news&id=2366074 [SID1234529329]). The DSMB congratulated Athenex on the rapid patient recruitment and the promising results achieved. The DSMB noted that more than 320 patients have already been recruited and recommended that Athenex continue this study and complete the recruitment of patients.
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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."
Dr. Johnson Lau, Athenex’s Chairman of the Board and Chief Executive Officer, stated, "The positive recommendation of the DSMB regarding the Oraxol Phase III study in patients with metastatic breast cancer, in combination with the successful completion of two Phase III clinical studies for KX-01 for Actinic Keratosis ahead of schedule as previously announced on July 26, 2018, together underscore the excellent execution by our clinical research and development team."