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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

BUFFALO, N.Y., Dec. 4, 2013 /PRNewswire/ -- Kinex Pharmaceuticals announced today that they have received Orphan Drug designation for KX02 for the treatment of gliomas, which are the most common and aggressive form of brain cancer.  Orphan drug status qualifies Kinex for seven years of exclusivity after formal marketing approval, as well as further development incentives. KX02, a dual src/pre-tubulin inhibitor, is a small molecule drug that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including those that are resistant to Temozolomide (T98G), the most widely used chemotherapy for the treatment of malignant glioma.  In a well-established brain tumor animal model, KX02 consistently clears brain tumors after 4 weeks of therapy, in 30-60% of treated animals. These studies showed that KX02 induced more necrosis compared to Temodar, and also generated an immune response to the glioblastoma tumor cells. Pharmacokinetic studies showed that KX02 is absorbed orally and has 76% penetration into brain tissue from plasma. 

Dr. David Hangauer, Chief Scientific Officer of Kinex stated, "Receiving Orphan Drug Status for KX02 speaks to the need for new treatment options for patients with gliomas. KX02 is a novel compound with good potential for these patients in terms of generating a durable immune response to tumor cells in mice that allow the animals to live to their full life expectancy without tumor recurrence or further drug treatment.  We are looking forward to moving this novel compound into the clinic."

"This is an important regulatory milestone for Kinex," stated Dr. Lyn Dyster, Senior VP of Operations at Kinex.  "The orphan drug designation will facilitate our goal of developing KX02 as a potentially new and effective treatment for patients with gliomas. The standard treatment for glioblastoma consists 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 obtain tax credits related to development expenses, the potential reduction in FDA user fees and the opportunity to obtain grant funding to defray clinical expenses.

About Kinex:
Founded in 2002, Kinex is a global biotechnology company focused on the development and commercialization of next generation oral therapies for cancer and immunomodulatory diseases. The company is dedicated to delivering innovative drugs that can have a life-changing impact on patients.  Through consistent investment in R&D and scientific excellence the company is developing important drug programs that address unmet medical needs and focus on critical factors that can improve outcomes.   It is Kinex's goal to have oral oncology treatment and maintenance platforms as well as  breakthrough drugs involving the immune system to help patients prevail over their disease. Kinex and its partners currently have four global clinical trials ongoing at highly regarded medical institutions.    Investigational compounds are being studied in a variety of solid tumors, including breast cancer, ovarian cancer, colon cancer, glioblastoma multiforme and gastric cancer.  More information of Kinex can be found at www.kinexpharma.com

About XiangXue:
Guangzhou XiangXue Pharmaceutical Co., Ltd (XPH) is a publicly traded pharmaceutical company headquartered in Guangzhou, China. The primary business of the Company is the manufacturing and marketing of pharmaceutical products, including herbal medicines, western medicines and biomedical engineering products. The company is actively expanding its product pipeline through research and development efforts and through in-licensing in areas of unmet medical needs. More information on XPH can be found at www.xphcn.com


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