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Kinex Pharmaceuticals Announced that the U.S. Food and Drug Administration has Granted Orphan Drug Status to KX02 for the Treatment of Gliomas
Date:12/4/2013

ists of surgical removal of the tumor bulk, followed by radiation and chemotherapy with temozolomide.  KX02 has demonstrated the ability to clear gliomas in a well-established animal model and also prevent tumor recurrence in these animals and we are excited to move this novel compound into the clinical setting.   We have worked diligently with clinical sites to establish the trial protocols and expect to initiate a Phase 1 trial imminently."

XiangXue Pharmaceuticals is Kinex's collaborative development partner for KX02 in China and has an exclusive license from Kinex for this territory. Mr. YongHui Wang, Chairman and CEO of XiangXue Pharmaceuticals added, "Kinex has been an excellent collaborative partner.  Their ability to develop novel drugs and work closely with regulatory agencies continues to impress us and we are very pleased that the FDA has granted Orphan Drug Status for KX02. Glioblastoma is an aggressive cancer with few treatment alternatives.  In fact, the average patient with malignant glioblastoma has a life expectancy of less than 12 months once they are diagnosed with the disease.  I am hopeful, based on promising animal studies, that KX02 can provide a new treatment option for this devastating disease. XiangXue is developing our IND application for the Chinese State FDA and we are planning to initiate KX02 trials for Chinese patients with brain tumor patients in 2014."

About orphan drug status:
FDA Orphan Drug Designation is designed to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the United States. This designation will provide Kinex with seven years of marketing exclusivity for KX02 in the treatment of glioblastoma patients if KX02 is approved for this indication. Orphan drug designation also affords the potential to ob
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SOURCE Kinex Pharmaceuticals
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