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Kinex Announces First Patient Dosed in Phase Ib Study of Oraxol, an Orally Dosed Paclitaxel
Date:10/28/2013

BUFFALO, N.Y., Oct. 28, 2013 /PRNewswire/ -- Kinex Pharmaceuticals today announced that the first patient has been dosed in its Phase Ib Oraxol study.  Oraxol allows for oral delivery of paclitaxel when combined with Hanmi Pharmaceutical's absorption enhancer, HM30181A.  This trial is being conducted in the United States.  Oraxol is in PII studies in Korea and will commence a PI in New Zealand in 2014.  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.

This single arm, dose escalation study is designed to bridge the safety, pharmacokinetics and tolerability of Oraxol that was observed by Hanmi Pharmaceutical in their Korean trials.  Kinex expects to enroll 25-35 patients.  Clinical studies of Oraxol to date suggest that this potent, oral version of paclitaxel will impact a broad spectrum of cancers.

Dr. Wen Wee Ma, MBBS, Assistant Professor at Roswell Park Cancer Institute and Primary Investigator for the Phase Ib trial stated, "Our team at Roswell Park has broad experience developing taxane based compounds.  Oraxol is an exciting program for us as it offers many important potential benefits to patients and clinicians including tolerability, convenience of oral administration and increased efficacy.  The design of this trial was guided by the predictive PK of Oraxol developed by Kinex and Roswell Park and we are extremely excited by its launch."

"The initiation of Kinex's Phase Ib is another important step in the Kinex /Hanmi collaboration," said Dr. Lyn Dyster, Senior Vice President of Operations. "The trial is des
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SOURCE Kinex Pharmaceuticals
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2. Dr. David Hangauer, Chief Scientific Officer and Co-Founder, commits his career to Kinex Pharmaceuticals
3. Kinex Receives Research Support from the Hong Kong Innovation and Technology Commission (ITC)
4. 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
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8. Kinex Pharmaceuticals Chief Scientific Officer, Dr. David Hangauer, named the American Cancer Societys 2013 Honoree for its Cuisine for a Cure event
9. Hanmi and Kinex Announced Korean FDA Allowance of the KX01 IND Application
10. Kinex Pharmaceuticals Appoints Mr. Patrick Gallagher Vice President of Business Development and Investor Relations
11. Kinex Pharmaceuticals Receives Substantial Strategic Investment
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