Navigation Links
Kinex Announces that the US FDA Allows their IND to Begin KX02 Clinical Trials
Date:6/4/2013

BUFFALO, N.Y., June 4, 2013 /PRNewswire/ -- Kinex Pharmaceuticals, Inc. announced today, that the FDA has allowed its Investigational New Drug (IND) application for KX02, Kinex's dual src/pretubulin inhibitor for the glioblastoma setting.   KX02 is partnered in the greater China territory with XiangXue Pharmaceuticals (300147.SZ) of Guangzhou, China.  KX02 is Kinex's second internally developed compound to enter clinical studies and Phase I clinical protocols are being finalized with the FDA.  Kinex's first internally developed compound, KX01, is currently in clinical trials in both the USA and Korea in a variety of indications.  In collaboration with Hanmi Pharmaceuticals, Oraxol and Oratecan are also in the clinic. Kinex has also recently partnered with ZenRx on the development of Oraxol and Oratecan in the New Zealand and Australia Territory.

KX02, a lipophilic dual src/pretubulin inhibitor, was discovered and developed by Kinex Pharmaceuticals through their internal R&D efforts.  It is a small molecule that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of malignant glioma.  In a well-established brain tumor animal model, KX02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals.  Pharmacokinetic studies showed that KX02 is absorbed orally and has 76% penetration into brain tissue from plasma.  Mouse tumor model studies showed that KX02 induced more necrosis of the glioma compared to Temodar, and also engaged a durable immune response to the glioblastoma tumor cells.  The intellectual property of KX02 as a new chemical entity is protected by issued patents in the US, China and other countries globally to between December 2025 and March 2031 (depending on the country and claims).  Kinex Pharmaceuticals noted that the patent application including KX02 has very recently been allowed by the Chinese Patent Office (Application 200580048796.7 with the Assignment number CN101184734A).

Dr. David Hangauer , Chief Scientific Officer of Kinex stated, "We are delighted that the FDA has accepted our IND for KX02.  In stereotactic mouse models, KX02 cleared brain tumors in about 50% of the animals and engaged a durable immune response to the tumor cells that allowed these mice to live to their full life expectancy without tumor recurrence or further drug treatment.  KX02 has the potential to be an important option for glioblastoma and brain metastasis patients.   This is a difficult to treat patient population with limited options and we look forward to moving into the clinic as soon as possible."

Mr. YongHui Wang , Chairman and CEO of XiangXue Pharmaceuticals, Kinex's strategic partner for the development of KX02 in China, added, "We are glad to know that the US FDA has allowed the IND for KX02.  XiangXue is developing our IND application for the Chinese State FDA and we hope to initiate KX02 trials for Chinese brain tumor patients in 2014.  The collaboration with Kinex has been very fruitful and the data generated from an ongoing Kinex KX02 phase I trial will provide us with strong support for our IND application.  We look forward to including KX02 in the clinical pipeline of XiangXue Pharmaceuticals very soon.   We believe that KX02 has the potential to create significant value for both companies."

"It is gratifying to see another of Kinex's internally discovered compounds moving from the bench to the clinic.  With my four decades of drug discovery and development experience, I have had the opportunity to see a number of important discoveries advance into groundbreaking compounds.    We believe that KX02 has this potential and can satisfy an important unmet need for the oncology community.  I remain impressed by the creative ways Kinex and its partners are advancing novel and meaningful compounds.  I am very proud to be affiliated with this productive and committed team," added Dr. Allen Barnett , President Emeritus and co-founder of Kinex Pharmaceuticals.

Kinex Inquiries:
Patrick Gallagher
Vice President, Business Development and Investor Relations
Kinex Pharmaceuticals
701 Ellicott Street
Buffalo, NY 14203
pgallagher@kinexpharma.com


'/>"/>
SOURCE Kinex Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Kinex Pharmaceuticals and Zenith Technology Corporation announce the execution of a collaborative licensing agreement
2. Kinex Pharmaceuticals Chief Scientific Officer, Dr. David Hangauer, named the American Cancer Societys 2013 Honoree for its Cuisine for a Cure event
3. Hanmi and Kinex Announced Korean FDA Allowance of the KX01 IND Application
4. Kinex Pharmaceuticals Appoints Mr. Patrick Gallagher Vice President of Business Development and Investor Relations
5. Kinex Pharmaceuticals Receives Substantial Strategic Investment
6. Xiangxue Pharmaceuticals to Acquire Rights for a Promising Drug Candidate from Kinex Pharmaceuticals for the Greater China Territory
7. Cheetah Medical Announces New Management Team
8. Accelerate Diagnostics Announces Plans For Rights Offering To Stockholders
9. Array BioPharma Announces Proposed Public Offering of Convertible Debt
10. Gulf Coast Spine Care Announces New Neck Pain Treatments
11. HPN Announces Team POWERDOT Wins $500,000 As Current Leader
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
(Date:6/23/2016)... Calif. , June 23, 2016 ... CST on Thursday, July 7, 2016 , , , , ... ) , , , , EXPERT PANELISTS:  , , ... Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar ... The global pharmaceutical industry is witnessing an exceptional ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
Breaking Medicine News(10 mins):