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BUFFALO, N.Y. — Athenex, Inc., Buffalo, NY, a global specialty oncology pharmaceutical company focusing on the development and commercialization of next generation therapies for cancers and supportive therapies, announced today that its partner, Guangzhou Xiangxue Pharmaceutical Co. Ltd., (Xiangxue) has received the Chinese FDA Investigational New Drug (IND) approval to begin clinical trials for KX-02 tablet for glioblastoma in May 2017 under the Class 1 New Drug Regulation in China. Athenex also received the US FDA allowance for KX-02 IND in 2014.
KX-02 is a new Src protein tyrosine kinase (PTK) inhibitor and tubulin polymerization inhibitor designed and developed by Athenex. It can disrupt cancer cell division, induce cell cycle arrest, apoptosis and cancer cell death. KX-02 can also cross the blood-brain-barrier and has induced durable complete remissions of glioblastoma in human xenograft animal models without sustained therapy.
Rudolf Kwan, Athenex's Chief Medical Officer stated, "Our partner Xiangxue submitted to the Chinese FDA an application for Class 1 clinical trial approval for the KX-02 tablet and obtained the approval earlier than the usual timeline of one year. This is a testament to both our companies' focus on developing cutting-edge oral treatments for cancer. Xiangxue has been a great partner throughout this process, and we remain focused on developing first and best-in-class innovative anti-cancer drugs to market globally by ourselves and with partners."