Kinex Announces that the US FDA Allows their IND to Begin KX02 Clinical Trials
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, China and other countries globally to between December 2025 and March 2031 (depending on the country and claims). Kinex Pharmaceuticals noted that the patent application including KX02 has very recently been allowed by the Chinese Patent Office (Application 200580048796.7 with the Assignment number CN101184734A).
Dr. David Hangauer, Chief Scientific Officer of Kinex stated, "We are delighted that the FDA has accepted our IND for KX02. In stereotactic mouse models, KX02 cleared brain tumors in about 50% of the animals and engaged a durable immune response to the tumor cells that allowed these mice to live to their full life expectancy without tumor recurrence or further drug treatment. KX02 has the potential to be an important option for glioblastoma and brain metastasis patients. This is a difficult to treat patient population with limited options and we look forward to moving into the clinic as soon as possible."
Mr. YongHui Wang, Chairman and CEO of XiangXue Pharmaceuticals, Kinex's strategic partner for the development of KX02 in China, added, "We are glad to know that the US FDA has allowed the IND for KX02. XiangXue is developing our IND application for the Chinese State FDA and we hope to initiate KX02 trials for Chinese brain tumor patients in 2014. The collaboration with Kinex has been very fruitful and the data generated from an ongoing Kinex KX02 phase I trial will provide us with strong support for our IND application. We look forward to including KX02 in the clinical pipeline of XiangXue Pharmaceuticals very soon. We believe that KX02 has the potential to create significant value for both companies."
"It is gratifying to see another of Kinex's internally discovered compounds moving from the bench to the clinic. With my four decades of drug discovery and development experience, I have had the opportunity to see a number of important discoveries advance into groundbreaking compounds. We believe that KX02 has this potential and can satisfy an important unmet need for the oncology community. I remain impressed by the creative ways Kinex and its partners are advancing novel and meaningful compounds. I am very proud to be affiliated with this productive and committed team," added Dr. Allen Barnett, President Emeritus and co-founder of Kinex Pharmaceuticals.
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SOURCE Kinex Pharmaceuticals, Inc.