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Kinex Announces that the US FDA Allows their IND for Oraxol, an Oral Form of Paclitaxel that is in Phase II Clinical Trials in Korea, to Begin Clinical Trials in the US
Date:7/22/2013

pan>/Australia, and China. 

Recently, Kinex has received US FDA allowance on the KX02 IND, a program that Kinex has partnered with Xiangxue Pharmaceuticals for the greater China Territory.  Through their collaboration with Hanmi, one of Kinex's internally developed compounds, KX01, is also currently in clinical trials in both the USA and Korea in a variety of indications. 

Dr. Lyn Dyster, Senior Vice President of Operations, stated, "Working with the Hanmi team on the Oraxol IND has been terrific.  Their expertise and dedicated team, combined with our internal efforts, lead to a timely IND submission.  Given that Hanmi is in Phase II in Korea, their extensive preclinical and clinical knowledge of the compound was invaluable to our efforts.  Oraxol is an important program for both companies and we are excited to move forward with our clinical programs in the United States."

"The allowance of the Oraxol IND by the US FDA is a major step in our global development strategy," added Dr. Rudolf Kwan, Chief Medical Officer of Kinex.  "Combined with Hanmi's significant Oraxol clinical efforts in Korea and the potential for trials in New Zealand to begin in the near future, we are on track to leverage our team's combined infrastructure and development capabilities on a global basis.  We believe this approach will produce meaningful data in the most time efficient manner. I am very excited with this program."

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical said, "The Kinex team moved the IND process forward in a precise and expert manner. This is another major step forward in the collaboration between Kinex and Hanmi.  I believe that as part of our global growth strategy, our partnership wit
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