Kinex Announces First Patient Dosed in Phase Ib Study of Oraxol, an Orally Dosed Paclitaxel

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 designed to confirm that the Korean data is compatible with Oraxol's mechanism of action in non-Asians and to assess additional dosing regimens.  As paclitaxel's MOA is very well characterized, we are confident that our PK modeling work will prove predictive in this study.  Kinex is pleased to be working with Dr. Ma and Roswell Park as well as the University of Colorado on this trial and we will name an additional site in the near future. We continue to do clinical and pre-clinical work on additional compounds in the Orascovery pipeline."

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical commented, "The Kinex team has delivered another major milestone in our global development strategy.  Hanmi has long wanted Oraxol and the Orascovery platform to be global initiatives as we believe they will improve patient outcomes and provide additional options to healthcare systems. Kinex's efforts and capabilities will help make this goal a reality."  

"Patients need better chemotherapeutic options.  Taxanes are efficacious, but they come with significant side effects.  It is widely recognized that greater tolerability could lead to better patient outcomes," said Dr. Rudolf Kwan, Chief Medical Officer of Kinex.  "The dose escalation in the US Oraxol trial will help us further quantify Oraxol's benefits versus standard of care and will provide Kinex and Hanmi an excellent roadmap for disease directed studies as we progress.  Hanmi's Phase II trials continue in Korea and the addition of an US trial drives our global growth strategy forward in a significant manner.  We continue 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."

About Oraxol:

Oraxol is 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.

SOURCE Kinex Pharmaceuticals