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Athenex Announces Encouraging Early Clinical Efficacy and Safety Data of Oraxol in Clinical Trial for the Treatment of Breast Cancer

BUFFALO, N.Y., Jan. 22, 2018 (GLOBE NEWSWIRE) -- Athenex (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 encouraging preliminary efficacy and safety data of Oraxol in the treatment of breast cancer in a pharmacokinetics (PK) and Phase I/II clinical trial of 24 patients in Taiwan. Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, an effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel P-gp inhibitor).

Among the first 12 evaluable patients, 50% had a partial response (>30% tumor shrinkage) and 50% had stable disease (all patients had tumor reduction, some up to 27%). There was no progressive disease. The follow-up time was only 2.6 months and such early response results are most encouraging. Grade 4 neutropenia was observed in 3 patients, all recovered completely with no patient death. There was no neuropathy.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, “We have seen consistent encouraging results in different clinical studies, showing the robust performance of Oraxol. We are delighted by the recent recommendation and positive comments from the Drug Safety and Monitoring Board, as well as the United Kingdom Medicines and Healthcare products Regulatory Agency giving Oraxol a Promising Innovative Medicine designation that will facilitate the development of Oraxol in Europe. We are very excited with these encouraging results and we are moving full speed to develop Oraxol for cancer patients in need of an effective oral paclitaxel with very low incidence of neuropathy.”

Athenex previously announced that the Drug Safety and Monitoring Board unanimously recommended the continuation of our Phase III clinical trial comparing Oraxol versus intravenous paclitaxel in the treatment of metastatic breast cancer after the interim analysis of the first 90 patients on October 5, 2017. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018.

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex.

PharmaEssentia Corp., licensed the Taiwan rights to Oraxol from Athenex and is a partner in the development of Oraxol in Taiwan.

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.  The Company’s current clinical pipeline is derived from two different platform technologies:  Athenex’s Orascovery and Src Kinase Inhibition platforms. Part of the Orascovery platform is Athenex's lead proprietary product, Oraxol. Oraxol applies a unique approach based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to administer paclitaxel orally, potentially allowing for improved safety and efficacy profile relative to IV paclitaxel. Oraxol is currently in a pivotal Phase III clinical trial for metastatic breast cancer and is also being evaluated in combination with Eli Lilly's Cyramza in a Phase I trial for gastric cancer. 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.  Key clinical product candidates in this platform are KX-01 ointment for pre-cancerous lesions and KX-02 for glioblastoma multiforme, or GBM. In December 2017, we entered into a license agreement with Almirall, S.A. pursuant to which we granted to Almirall an exclusive license of KX-01 in the United States and substantially all European countries. In addition to its proprietary product portfolio, the Company also has a revenue generating API and Specialty Pharmaceuticals business. Athenex is headquartered in Buffalo, New York. 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. For more information, please visit

Forward-Looking Statement Disclaimer/Safe Harbor Statement
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; need to raise additional capital; competition; intellectual property risks; risks relating to doing business in China; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at or upon request from our Investor Relations Department. We assume no obligation and do not intend to update these forward-looking statements, except as required by law. CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Jim Polson
Tel: +1-716-427-2952
Athenex, Inc.

Athenex, Inc.