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Kinex Announces that the US FDA Allows their IND to Begin KX02 Clinical Trials
Date:6/4/2013

BUFFALO, N.Y., June 4, 2013 /PRNewswire/ -- Kinex Pharmaceuticals, Inc. announced today, that the FDA has allowed its Investigational New Drug (IND) application for KX02, Kinex's dual src/pretubulin inhibitor for the glioblastoma setting.   KX02 is partnered in the greater China territory with XiangXue Pharmaceuticals (300147.SZ) of Guangzhou, China.  KX02 is Kinex's second internally developed compound to enter clinical studies and Phase I clinical protocols are being finalized with the FDA.  Kinex's first internally developed compound, KX01, is currently in clinical trials in both the USA and Korea in a variety of indications.  In collaboration with Hanmi Pharmaceuticals, Oraxol and Oratecan are also in the clinic. Kinex has also recently partnered with ZenRx on the development of Oraxol and Oratecan in the New Zealand and Australia Territory.

KX02, a lipophilic dual src/pretubulin inhibitor, was discovered and developed by Kinex Pharmaceuticals through their internal R&D 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, KX02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals.  Pharmacokinetic studies showed that KX02 is absorbed orally and has 76% penetration into brain tissue from plasma.  Mouse tumor model studies showed that KX02 induced more necrosis of the glioma compared to Temodar, and also engaged a durable immune response to the glioblastoma tumor cells.  The intellectual property of KX02 as a new chemical entity is protected by issued patents in the US,
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SOURCE Kinex Pharmaceuticals, Inc.
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