Navigation Links
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/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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Kinex Pharmaceuticals Will Take the Lead in the Orascovery Program Development in China
2. Kinex Announces that the US FDA Allows their IND to Begin KX02 Clinical Trials
3. Kinex Pharmaceuticals and Zenith Technology Corporation announce the execution of a collaborative licensing agreement
4. Kinex Pharmaceuticals Chief Scientific Officer, Dr. David Hangauer, named the American Cancer Societys 2013 Honoree for its Cuisine for a Cure event
5. Hanmi and Kinex Announced Korean FDA Allowance of the KX01 IND Application
6. Kinex Pharmaceuticals Appoints Mr. Patrick Gallagher Vice President of Business Development and Investor Relations
7. Kinex Pharmaceuticals Receives Substantial Strategic Investment
8. Xiangxue Pharmaceuticals to Acquire Rights for a Promising Drug Candidate from Kinex Pharmaceuticals for the Greater China Territory
9. ANI Pharmaceuticals, Inc. Announces Date for Second Quarter 2013 Earnings Release
10. QRxPharma Announces Collaboration With Aesica
11. FDAnews Announces Leading the Climb: Seven Essentials of GMP Workshop
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
(Date:10/2/2017)... INDIANAPOLIS , Oct. 2, 2017  Eli Lilly ... its financial results for the third quarter of 2017 ... a conference call on that day with the investment ... performance. The conference call will begin at ... public can access a live webcast of the conference ...
Breaking Medicine Technology:
(Date:10/13/2017)... Calif. (PRWEB) , ... October 13, 2017 , ... Many ... dementia. However, many long-term care insurance companies have a waiver for care if the ... 90-day elimination period, when the family pays for care, is often waived, so the ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... in post-acute health care, have expanded their existing home health joint venture through ... AccentCare has been operating a joint venture home health company with Asante, delivering ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
Breaking Medicine News(10 mins):