BUFFALO, N.Y., Oct. 18, 2016 /PRNewswire/ -- Athenex today
announced that its development partner for KX-02, Xiangxue Pharmaceuticals Company Limited, has publicized that the Guangdong
Province Food and Drug Administration (FDA) declared completion of the Investigational New Drug (IND) application for KX-02
active pharmaceutical ingredient and KX-02 Tablet and referred the IND to the Center of Drug Evaluation (CDE) of China FDA for
review. The IND application to the Chinese FDA was submitted jointly by Xiangxue New Drug Development Company Limited, Xiangxue
Pharmaceuticals Limited, and Hangzhou Converd Co., Ltd.
The Guangdong Province FDA has determined, after their inspection of the factory and initial review of the IND submission,
that it is complete and was referred to the Center of Drug Evaluation (CDE) of China FDA for review. This IND application has
been assigned the application number CXHL1600187.
In 2012, Athenex and Xiangxue Pharmaceuticals announced the execution of a license agreement granting Xiangxue Pharmaceuticals
exclusive rights to KX-02, for all oncology indications, in the greater China territory
(China, Hong Kong, Taiwan) and
Singapore.
KX-02, a novel lipophilic dual Src/pretubulin inhibitor, was discovered and developed by Athenex through their internal
research and development efforts. It is a small molecule that has shown potent inhibitory activity against a broad panel of brain
tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of
malignant glioma. In a well-established brain tumor animal model, KX-02 has been shown to consistently clear brain tumors after 4
weeks of therapy in 30-60% of treated animals. Pharmacokinetic studies showed that KX-02 is absorbed orally and has 76%
penetration to brain tissue from plasma.
KX-02 is already in Phase 1 study in the US and has been assigned "Orphan Drug" status by the US FDA. Preclinical studies have
shown that KX-02 showed excellent brain penetration and promising anti-tumor activities in mouse brain tumor models. A proportion
of rodents cleared the tumor after 6 weeks of oral KX-02 treatment.
About Athenex
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 U.S. Commercial Segment and an Internal Supply Chain. Our Oncology Innovation
Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites, human
absorption biology and through the application of our proprietary research and selection processes in the lab. Our current
clinical pipeline is derived from two different platforms technologies we call Orascovery and Src Kinase Inhibition. The
Orascovery platform is based on our belief that the next generation of cancer treatments will be driven by orally based
cytotoxics allowing clinicians to potentially increase the amount of drug exposure per treatment cycle and increase the number of
treatment cycles tolerated by patients. The Src Kinase inhibition platform includes novel small molecules addressing unmet
medical needs that work through multi-mechanisms of action including inhibition of Src activities and tubulin polymerization
inhibition. Athenex's several hundred employees are dedicated to delivering innovative drugs that can have a life-changing impact
on cancer patients. We have 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 about Athenex's portfolio of proprietary products and clinical studies, please visit www.athenex.com
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SOURCE Athenex