Athenex Announces Progress in Registration Studies of Oral Oncology Drug and China Approvals of Symptom Therapeutic Products

BUFFALO, N.Y. and HONG KONG, Dec. 15, 2015 /PRNewswire/ -- Athenex, Inc. announced today several significant developments in its proprietary product pipeline within each of its three innovative platforms: Oral Absorption, Kinase Inhibitors and Symptom Therapeutics.

Oral Absorption Platform
A pivotal registration study has commenced in the fourth quarter 2015 for Oraxol, the proprietary oral capsule formulation of paclitaxel. Dr. Rudolf Kwan, Athenex Chief Medical Officer commented, "We believe Oraxol will be an important anti-cancer drug for patients throughout the world. Our positive clinical data from Phase 1 and 2 studies have guided us to invest in a comprehensive registration program, with a Phase 3 registration study recently initiated." Dr. Wing-Kai Chan, Athenex Asia/Pacific Head of Clinical added, "Our teams in the U.S. and Asia have been encouraged by the Phase 2 patient survival data of Oraxol. We will initiate in Asia a second Phase 3 study to support our registration soon."

Athenex launched the oral absorption platform in 2011 through the original in-license from Hanmi Pharmaceuticals of a proprietary PgP inhibitor shown to be not systemically absorbed in patients. In addition to Oraxol in the clinic, Athenex is developing Oratecan, a proprietary oral form of irinotecan, which has completed a Phase 1 study in Korea and is currently in a clinical stage of development in the U.S.

The Athenex Hong Kong research team also recently developed a proprietary clinical gel capsule formulation of Oradoxel, an oral form of docetaxel, with support from the Hong Kong Innovation and Technology Commission. Multiple clinical studies of Oradoxel are expected to commence in early 2016 as the third oral anti-cancer drug entering the clinic in our oral absorption platform. Athenex is developing a fourth orally absorbed PgP substrate anti-cancer drug, topotecan, in conjunction with Hong Kong Polytechnic University and McGill University.

Kinase Inhibitor Platform
Athenex is accelerating the clinical registration program of KX-01 ointment based on very encouraging pilot clinical data observed for the treatment of actinic keratosis. When left untreated, approximately 10% of actinic keratosis cases turn into squamous cell carcinoma, the second most common form of skin cancer. KX-01, in its topical ointment form, induces apoptosis of the abnormally proliferating cells in the skin. Dr. Rudolf Kwan commented, "KX-01 ointment appears to have good activities and, should these be validated in registration studies, would be very competitive against current products in the market. We are accelerating the development and expect to launch a Phase 2 study in first quarter and pivotal registration studies by fourth quarter 2016."

Using a different concentration of the active ingredient in KX-01 ointment, a Phase 1 clinical study was recently initiated in patients with psoriasis in conjunction with our Taiwan partner, PharmaEssentia.

The kinase inhibitor platform also includes two oral oncology clinical candidates, KX-01 and KX-02. Based on recently completed Phase 1 studies, both as monotherapy and as add-on to IV paclitaxel, we are evaluating oral KX-01 for probe studies in 2016. KX-02 for glioblastoma was designated by the FDA as an orphan drug candidate and is progressing well in a Phase 1 clinical study. 

Symptom Therapeutics Platform
Athenex recently received Chinese Food and Drug Administration (Chongqing office) approval of CQ-02 and CQ-03 proprietary hydrogel products for the treatment of a variety of skin based ailments. These approvals complement the approval last year of CQ-01. All of these approved products will be manufactured in Athenex's Chongqing factory in the Fengdu District. Athenex China leader William Zuo PhD commented, "The approved CQ class of products continues to demonstrate our team's ability to commercially launch innovative products in China. The CQ products are important to patients suffering from symptoms related to burn or surgical scars. We are at present working to develop hydrogel based therapeutics for symptoms caused by oncology treatments and we expect the registration clinical study will commence in 2016."

Athenex recently launched a Phase 1 study of an intranasal form of granisetron administration developed by our Hong Kong research team. Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting following chemotherapy. Dr. Benjamin Lee, Athenex President of Product Development of the Hong Kong R&D center, commented, "The pharmacokinetic profile showed that the intranasal form of this drug is absorbed much faster than oral administration. With this profile, we expect our product will exert clinical effect much quicker than the oral administration for the relief of nausea and vomiting symptoms for cancer patients after chemotherapies, radiation therapy, or post surgical operation."  A registration study is expected to be initiated in 2016.

Dr. Johnson Lau, Chairman and CEO of Athenex, commented "Thanks to the tremendous effort by the R&D teams in the U.S. and greater China, our oncology focused pipeline of products have advanced rapidly into various clinical stages of development. We deeply appreciate the support of our R&D team and our investors. We also would like to thank our collaborative partners including Hanmi Pharmaceuticals, Xiangxue Pharmaceuticals, PharmaEssentia and ZenRx, and our supporters, the Chinese Chongqing government, Hong Kong Innovation and Technology Commission, Hong Kong Polytechnic University, University of Hong Kong, McGill University, University at Buffalo, and Roswell Park Cancer Institute."

About Athenex, Inc.

Founded in 2003, Athenex is a global specialty oncology pharmaceutical company dedicated to delivering innovative drugs that can have a life-changing impact on cancer patients. We are developing numerous innovative oncology products across three platform technologies; Oral absorption, kinase inhibitors and symptom therapies. In addition to our existing products on the market, our clinical pipeline includes several late stage product candidates. To support our bridge between the U.S. and China markets and the launching of our clinical pipeline, we have numerous companies that are part of our family. Through this connected innovation and manufacturing supply chain presence, we can identify, develop and deliver proprietary medical technology across continents and multiple regulatory environments. We have offices throughout the U.S. and China.

For more information, please visit www.Athenex.com

SOURCE Athenex

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