Navigation Links
Hanmi and Kinex Announced Korean FDA Allowance of the KX01 IND Application

BUFFALO, N.Y. and SEOUL, South Korea, Nov. 6, 2012 /PRNewswire/ -- Kinex Pharmaceuticals and Hanmi Pharmaceutical announced today that the Korean FDA (KFDA) has accepted Hanmi's Investigational New Drug (IND) application for KX-01, Kinex's dual src/pretubulin inhibitor, in the oncologic setting. The data package included Kinex's preclinical and clinical data for KX-01, as well as Hanmi's preclinical gastric cancer data.

KX01 differentiates itself as an inhibitor that targets the kinase substrate pocket and therefore offers an excellent efficacy as well as safety profile. In addition, KX01 has potent inhibitory activity against pre-tubulin. KX01 has been shown to be very effective against a broad range of cancers in both in vitro experiments and in animal cancer models. Importantly, the compound has synergistic/additive activities with a number of first line chemotherapeutic agents. A completed Phase I study, in patients with end-stage cancer, showed a desirable safety profile and stable disease or clinical response in approximately 25% of the patients. Proof-of-concept studies are ongoing. The composition of matter of KX01 is covered by issued patents.

Dr. Gwan-Sun Lee, President and CEO of Hanmi said, "This is another important milestone in our successful partnership with Kinex. This also demonstrates our growing focus and commitment to oncology therapeutics."

"This is a major step forward," added Dr. Jeewoong Son, Senior VP and Head of Innovation R&D, at Hanmi. "The close collaboration between our scientific teams has helped define our initial development strategy. Kinex is a great partner and continues to show strong support. We will continue focus our efforts on unmet oncology needs together."

"Kinex is pleased to be working with such a committed partner," commented Dr. Lyn Dyster, SVP of Operations. "Hanmi's ability to work with their local regulatory bodies to advance the KX01 development program in Korea is a critical step in our overall development strategy."

Dr. Rudolf Kwan, CMO of Kinex stated, "The acceptance of Hanmi's IND by the Korean FDA is a crucial piece of our mutual development plans and will generate important clinical data for both parties soon. Kinex will also pursue additional development pathways to broaden KX-01's potential utility."

Kinex is also developing oral forms of Paclitaxel and Irintotecan, both are in clinical stages of development, through a licensing agreement with Hanmi Pharmaceuticals. Kinex is also developing KX02 for brain tumors with Xiangxue Pharmaceuticals based in Guangzhou, China.

About Kinex Pharmaceuticals, LLC

Kinex Pharmaceuticals, headquartered in Buffalo, New York, USA, is using its proprietary technologies Mimetica and Opal to discover and develop novel drugs for oncology and immune-modulatory diseases. More information of Kinex Pharmaceuticals can be found at or contact Mr. Patrick Gallagher,,  716-898-8626

Kinex Pharmaceuticals, LLC, Caution Regarding Forward-looking Information

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, Kinex Pharmaceuticals cautions investors that any forward-looking statements or projections made by Kinex Pharmaceuticals, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected

About Hanmi Pharmaceutical, Co., Ltd

Established in 1973 in Korea, Hanmi Pharmaceuticals now is one of the top 5 pharmaceutical companies in terms of revenue, and the most R&D focused company with the highest R&D investment for several years. Hanmi has been successful for a few decades with high flexibility, continuously changing its market/development strategy from first generics to IMD & FDC (Incrementally Modified Drug and Fixed Dose Combination) to new drug development including innovative small molecules and biologics. During the period of significant changes, Hanmi made multiple strategic collaboration relationships with multinational companies and biotech companies.

For further information about Hanmi Pharmaceuticals, please refer to

SOURCE Kinex Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Xiangxue Pharmaceuticals to Acquire Rights for a Promising Drug Candidate from Kinex Pharmaceuticals for the Greater China Territory
2. Kinex Pharmaceuticals Receives Substantial Strategic Investment
3. Kinex Pharmaceuticals Appoints Mr. Patrick Gallagher Vice President of Business Development and Investor Relations
4. Gen-Probe Withdraws from Previously Announced Investor Presentations
5. Genesis Biopharma Announces Termination of Previously Announced Proposed Public Offering
6. LTCLINK-Tank Competition Announced To Introduce Your Emerging Product to the Aging Care Continuum
7. Delcath Announced Changes To Board Of Directors
8. Speakers Announced for the 2012 International Iridoid Research Symposium
9. Bausch + Lomb Announces Extension of Early Tender Date for Its Previously Announced Tender Offer for Its 9 7/8% Senior Notes due 2015 (CUSIP Nos. 071707AN3, U07190AA6 and 071707AP8)
10. Online Pharmacy Domain Policy Changes Announced by ICANN Registrar Corp.
11. Bausch + Lomb Announces Final Results for Its Previously Announced Tender Offer for Its 9 7/8% Senior Notes due 2015 (CUSIP Nos. 071707AN3, U07190AA6 and 071707AP8)
Post Your Comments:
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
(Date:6/24/2016)... ... ... makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum ... by 2020 and then adjusting it yearly to increase at the same rate as the ... wage floor does not erode again, and make future increases more predictable. , The company ...
Breaking Medicine News(10 mins):