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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 cons
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