Hanmi Pharmaceuticals announces a positive study on Oraxol use in a Phase I/II clinical proof-of-concept study 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 done in 46 subjects with Stage IV gastric cancer who had failed multiple chemotherapies. Oraxol monotherapy 150 mg/m2 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/m2). Forty-three 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 four patients (9.3%) who had partial responses (reduction of tumour 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 22 July 2013. A Phase I study at three US clinical sites is ongoing as well as a Phase I 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."