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Kinex Pharmaceuticals Announces Allowance of the Investigational New Drug (IND) application for KX2-391 Ointment by the United States Food and Drug Administration (FDA)
Date:7/24/2014

are also leading the effort to advance this formulation for the clinical indication of psoriasis in Taiwan." Dr. KoChung Lin, CEO of PharmaEssentia said, "We are delighted to see the successful collaboration in the allowance for the KX2-391 IND for Actinic Keratosis by US FDA. We are also looking forward to applying for a Taiwan IND for KX2-391 ointment and launching our clinical development program for psoriasis in Taiwan.  Our collaboration with Kinex has been rewarding and we will use our joint momentum to bring KX2-391 Ointment into the clinic in Asia, expeditiously."

KX2-391 is also being developed as an oral agent for oncology indications and has been tested in four clinical studies, thus far.  In defining its pharmacological activity in tumor cells, both in vitro and in vivo,  KX2-391 has been shown to have potent activity against a wide range of solid tumors as well as leukemia cell lines, including cell lines that are resistant to commonly used cancer drugs. Kinex has also partnered with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in the Korea and greater China Territory. In partnership with Hanmi Pharmaceuticals, the safety, tolerability and pharmacokinetics of KX2-391 have been studied in more than 120 patients in both solid and liquid tumors. A study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored through the collaboration with Hanmi Pharmaceuticals. 

Dr. Wing Kai Chan, Head of Clinical Operations for Asia Pacific for Kinex, said, "The ability to develop the new topical formulation of KX2-391 for hyper-proliferative skin diseases shows how Kinex is effectively building up its pipeline of drug candidates.  I look f
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