Hanmi Pharmaceuticals and Collaborative Partner Kinex Pharmaceuticals Report
Encouraging Results on Oraxol® for Patients with Advanced Gastric Cancer from
a Phase I/II Clinical Study
BUFFALO, N.Y. and SEOUL, South Korea, June 30, 2014
BUFFALO, N.Y. and SEOUL, South Korea, June 30, 2014 /PRNewswire/ -- Hanmi
Pharmaceuticals announces a positive study on Oraxol® use in a Phase I/II
clinical proof-of-concept study (Study HM-OXL-201) of Oraxol - an oral form of
the approved drug paclitaxel, with HM30181, a highly potent and selective,
P-glycoprotein inhibitor of the gastro-intestinal tract.
The study, entitled "A phase I-II clinical trial to determine the recommended
dose and to assess the efficacy, safety and pharmacokinetic profile of Oraxol
in patients with advanced/metastatic or recurrent gastric cancer," was
conducted at six clinical sites in South Korea. In the Phase I portion of the
study, PK, safety and tolerability were assessed in 10 patients. The Phase II
portion of the study was carried out in 46 subjects with Stage IV gastric
cancer who had failed multiple chemotherapies. Oraxol monotherapy 150 mg/m^2
was given once daily for two days each week, in a 3 out of 4-week cycle.
The pharmacokinetics of paclitaxel following Oraxol administration were
observed as in systemic circulation within the dose range studied (90-150
mg/m^2). 43 patients were evaluable for efficacy by RECIST criteria and 21
patients (49%) achieved stable disease or better (duration ranged from 3 to 17
months), including 4 patients (9.3%) who had partial responses (Reduction of
tumor burden between 41-52%, duration of partial response 4 - 14 months).
Hanmi Pharmaceuticals has been collaboratively working with Kinex
Pharmaceuticals for the global development of the Orascovery platform, and
Oraxol, as one of the candidates, is currently being further studied
worldwide. Kinex received allowance of its IND submission for Oraxol from the
US FDA on July 22, 2013. A phase 1 study at 3 US clinical sites is ongoing as
well as a Phase 1 study in New Zealand. Additional studies in South America,
Asia and the US are planned. Hanmi is working closely with Kinex for the
global development of Oraxol.
"Establishing a recommended Oraxol dose that optimizes efficacy and safety of
paclitaxel as monotherapy in patients with advanced gastric cancer
demonstrates the feasibility of this unique formulation as another potential
tool in the arsenal of cancer chemotherapies. We are pleased that the utility
of the Orascovery platform has been validated, with Oraxol as its first drug
candidate, in this Phase I/II study," said Dr. Jeewoong Son, Senior
Vice-President and Head of Innovation R&D of Hanmi Pharmaceuticals.
Dr. Rudolf Kwan, Chief Medical Officer of Kinex Pharmaceuticals, commented,
"This study confirmed that oral delivery of paclitaxel can be achieved to a
therapeutically effective level. The activity of Oraxol was exemplified by
controlling advanced refractory disease, as monotherapy, and achieving partial
responses. The ability to achieve therapeutic levels of paclitaxel that can be
sustained for significant duration opens the opportunity not only in providing
an alternative to the current IV administration route, but also for long term
maintenance therapy, or metronomic dosing."
"Our global team, consisting of Hanmi Pharmaceuticals (headquartered in
Korea), Kinex Pharmaceuticals (US), PharmaEssentia (Taiwan), and Zenith
Technologies (New Zealand), is encouraged with the Phase I/II clinical data
and we are moving forward to develop Oraxol for cancer patients," affirmed by
Dr. Wing Kai Chan, Vice President of Clinical Operations of Kinex
Pharmaceuticals. Dr. Chan also added, "Less toxic oral chemotherapy (Oraxol)
at home to replace intravenous paclitaxel chemotherapy in the hospital may
represent major benefits for cancer patients."
"Our global partnership team has only one mission – to develop the best
medicine to help patients," stated Dr. Gwan Sun Lee. Dr. Lee also added, "We
are delighted to work with Kinex Pharmaceuticals, and enjoy very much our
collaboration with their excellent management team. Together, we hope to
expedite the development of Oraxol for cancer patients so that they can
benefit from this new approach to treatment."
SOURCE Kinex Pharmaceuticals
Contact: Hanmi Pharmaceutical Co., Ltd., 45 Bangi-dong Songpa, Seoul 138-724
Korea, Phone: 82.2.410.9114, Website: http://www.hanmipharm.com; Kinex
Pharmaceuticals, Inc., 701 Ellicott Street, Buffalo, NY 14203, Phone:
716.898.8626, Website: www.kinexpharma.com, Email: email@example.com
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