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.
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
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/athenex-announces-xiangxue-pharmaceuticals-company-limited-its-kx-02-development-partner-in-china-has-achieved-a-regulatory-milestone-in-that-territory-300346660.html