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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

BUFFALO, N.Y., July 22, 2013 /PRNewswire/ --  Kinex Pharmaceuticals, Inc. announced today that the FDA has allowed its Investigational New Drug (IND) application for Oraxol.  Oraxol allows for oral delivery of paclitaxel when combined with Hanmi Pharmaceutical's absorption enhancer, HM30181A.   Kinex has global development and commercialization rights for Oraxol, excluding Korea, Japan and India that are owned by Hanmi, and New Zealand and Australia which were recently licensed to Zenith Technology Corporation.  Kinex, Hanmi and ZenRx will jointly develop Oraxol globally through a collaborative effort. Oraxol is Kinex's second IND to be allowed this year and the company will proceed to Phase I/Ib clinical protocols as planned. 

Oraxol is only one of many compounds that could be developed by Kinex and Hanmi through the Orascovery program.  Orascovery is based on an important platform technology developed by Hanmi Pharmaceuticals using compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor.   Suppression of the PGP pump allows certain clinically important compounds (such as paclitaxel, irinotecan, and others), which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and become bioavailable through oral administration.  Importantly, HM30181A is a very potent PGP inhibitor that is not systemically absorbed.

The Orascovery technology has led to the initiation of clinical trials being conducted with both an oral formulation of paclitaxel (Oraxol), currently in Phase II clinical trials in Korea, and an oral formulation of irinotecan (Oratecan), which has completed Phase I clinical trials in Korea. Further trials are being planned in Korea, the USA, New Zealand'/>"/>

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