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

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

PR Newswire

BUFFALO, N.Y. and SEOUL, South Korea, Nov. 6, 2012

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 andHead 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 www.kinexpharma.com or contact Mr. Patrick
Gallagher, pgallagher@kinexpharma.com, 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
www.hanmipharm.com

SOURCE Kinex Pharmaceuticals

Website: http://www.kinexpharma.com
 
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