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Athenex Announces Positive Recommendation by the Drug Safety Monitoring Board Upon the Second Interim Analysis and to Continue the Oraxol Phase III Program

1230 Days ago

BUFFALO, N.Y., Sept. 05, 2018 (GLOBE NEWSWIRE) -- 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, today announced 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). 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.

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.”

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 Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. The TCR-T platform is a cancer immunotherapy platform originally developed by Xiangxue Life Sciences and together with Athenex, established a Joint Venture that owns the global rights apart from China and led by Athenex. The metabolic manipulation of cancer was through depletion of circulating arginine, an amino acid that can be made by normal cells but not by a significant proportion of cancer through interruption of their urea cycle, a pathway essential for the synthesis of arginine, and thereby starving the cancer cells with interrupted urea cycle. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. 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, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing, China.


Athenex Contacts
Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Tel: +1 212-915-2564

Athenex, Inc.:
Randoll Sze
Email: randollsze@athenex.com 

Jacqueline Li
Email: jacquelineli@athenex.com

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