Kinex and Zenith Technology to Initiate Clinical Studies of an Oral Form of Paclitaxel (Oraxol) in New Zealand

 Kinex and Zenith Technology to Initiate Clinical Studies of an Oral Form of
                      Paclitaxel (Oraxol) in New Zealand

PR Newswire

BUFFALO, N.Y., March 19, 2014

BUFFALO, N.Y., March 19, 2014 /PRNewswire/ -- Kinex Pharmaceuticals announced
today to having received regulatory and ethics approvals to initiate the first
clinical study of an oral form of paclitaxel (Oraxol) in Dunedin Hospital in
Otago, New Zealand. This is the first clinical study of Oraxol in New
Zealand. Oraxol is also currently in clinical studies conducted in Korea and
in the United States of America.

Dr. Rudolf Kwan, Chief Medical Officer of Kinex stated "Kinex is grateful to
our colleagues in New Zealand who have been extremely helpful in getting the
approvals on time. We are delighted to have a very experienced clinical
oncology investigator, Dr. Christopher Jackson, to be principal investigator
of the first clinical study of Oraxol in New Zealand. Kinex is also delighted
to have the support of our partner, Zenith Technology and Dr. Tak Hung to
support this study. This is an important component of our global registration
strategy and is complementary to our clinical studies conducted by our partner
Hanmi Pharmaceuticals in Korea and clinical studies conducted by Kinex
Pharmaceuticals in the United States."

"Paclitaxel is a commonly used intravenous chemotherapy drug that has to be
administered by IV drip, meaning patients are tied to weekly visits to
hospitals to receive treatment. Patients need to have repeated injections of
chemotherapy in an effort to treat their cancer. Intravenous paclitaxel has
been widely used in hospitals around the world for more than 20 years. An oral
form of paclitaxel will be a major advance for cancer patients. The problem is
that paclitaxel cannot be absorbed orally, because the gut "pumps out" the
drug. Kinex has a revolutionary new delivery mechanism that blocks this pump
and allows the body to absorb paclitaxel orally. This novel delivery system
has been formulated with paclitaxel, to form a brand new cancer therapy –
Oraxol. Many of our patients have to travel many hours each week, have a
needle placed in their arm, receive chemo at hospital, and then travel home.
Our patients travel from Queenstown, Te Anau, Oamaru, Wanaka, and from all
over the lower South Island region. They get paclitaxel weekly, meaning they
lose a day a week to chemo. This new drug, if successful, could mean that
patients won't have to travel and so can spend more time at home with loved
ones, and doing things they want to do rather than being tied to the hospital.
I want patients with cancer to have time to spend with their families, not
spend their time with me getting chemotherapy at the hospital," commented Dr.
Christopher Jackson, Senior Lecturer, Department of Medicine, University of
Otago, New Zealand; Clinical Leader for Oncology Research in Dunedin Hospital,
New Zealand; and Co-founder of Mercy Cancer Care in Mercy Hospital, Dunedin,
New Zealand. Dr. Jackson also commented: "I am excited to see the preliminary
clinical data of good oral bioavailability of paclitaxel in Oraxol, and the
preclinical data of efficacy and fewer side effects (including no infusion
related hypersensitivity, few sensory neuropathy, and less bone marrow
suppression). We are honored to be selected as the first clinical site outside
the developers' countries to conduct clinical studies with this pioneer cancer
treatment."

"Zenith Technology is excited to be a collaborative partner with Kinex
Pharmaceuticals on Oraxol. Oraxol has an excellent potential. Oraxol may pave
the way for future consideration of low dose maintenance therapy or metronomic
dosing. We are excited that we may be developing the next generation of oral
oncology drugs for cancer patients. This study will help us to establish the
right dose of Oraxol for patients, and to ensure there are no unexpected
effects. We will be carefully measuring the blood levels of Oraxol and
comparing these to blood levels of paclitaxel, to ensure that patients don't
get over- or under-dosed with this drug. It will be an intensive study for the
patients, but has wide implications around the world. We are glad that New
Zealand is taking the lead on developing this exciting treatment, which if
successful, will benefit New Zealand patients first. The trial is set to open
in April and if successful, the drug could be available in the clinic in New
Zealand as early as 2016. Kinex Pharmaceuticals has a top notch management
team and they have been extremely supportive in helping us to initiate our
clinical studies in an expedited way. Zenith Technology is delighted to be
part of Kinex Pharmaceuticals' global partnership network," commented Dr. Tak
Hung, Managing Director.

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical commented:
"Hanmi Pharmaceuticals is excited with the initiation of clinical studies in
New Zealand. Our partnership with Kinex Pharmaceuticals is extremely fruitful.
In a short period of time, Oraxol is already being developed in different
geographic regions with good partners. This is another reflection of the
experience of the Kinex management team and also Kinex Pharmaceuticals' global
network. Hanmi Pharmaceuticals is grateful to our colleagues in University of
Otago and Zenith Technology to lead this effort."

About Oraxol:

Oraxol is 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.



SOURCE Kinex Pharmaceuticals

Website: http://www.kinexpharma.com
Contact: Kinex Pharmaceuticals, 701 Ellicott Street, Buffalo, NY 14203,
716-898-8626, info@kinexpharma.com
 
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