Kinex Announces that the US FDA Allows their IND for Oraxol, an Oral Form of Paclitaxel that is in Phase II Clinical Trials in

 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

PR Newswire

BUFFALO, N.Y., July 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/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 with Kinex
will benefit Hanmi by providing participation in major markets outside of our
traditional territories. US and New Zealand clinical trials are an important
example of that opportunity. We have great confidence in the Kinex team and
our expanding relationship."

Dr. Jeewoong Son, Senior VP and Head of Innovation R&D at Hanmi, commented,
"We are very proud to have Oraxol proceeding to clinical studies in the United
States. This is a great achievement. The Hanmi and Kinex alliance continues
to deliver important milestones. Hanmi has seen promising results in terms of
efficacy and reduced toxicity with our Oraxol clinical trials in Korea and we
hope to see the same benefits for patients in the US trials. We look forward
to moving ahead with ZenRx and Kinex with additional trials in New Zealand
later this year."

"I am proud to have a chance to work with the Kinex management team. I was
impressed by their domain knowledge. Their execution is also very impressive.
I look forward to finalizing the New Zealand and Australia development plan
with them very soon," added Dr. Cheung-Tak Hung, Managing Director for Zenith
Technology Corporation

For Kinex inquiries please contact:

Mr. Patrick Gallagher
Kinex Pharmaceuticals
701 Ellicott Street
Buffalo, NY 14203
pgallagher@kinexpharma.com



SOURCE Kinex Pharmaceuticals

Website: http://www.kinexpharma.com
 
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