Shanghai, China, February 22, 2012: Hutchison MediPharma Limited (“HMP”) today announces the initiation of the first-in-human Phase I clinical trial of Volitinib (HMPL-504) in Australia. Volitinib is a novel targeted therapy and a highly selective inhibitor of the c-Met receptor tyrosine kinase for the treatment of cancer. This is one of several oncology compounds discovered and developed by HMP and the first oncology compound from HMP to enter into clinical study in Australia. On December 21, 2011, AstraZeneca PLC and HMP announced they had entered into a global licensing, co-development and commercialisation agreement for Volitinib.
The Phase I study of Volitinib has been approved by the Bellberry Human Research Ethics Committee in Australia. It is being conducted initially at Sir Charles Gairdner Hospital (SCGH) under the direction and supervision of Dr. Michael Millward, Winthrop Professor of Clinical Cancer Research and Head of Medical Oncology Department at SCGH and University of Western Australia. The primary objectives of the Phase I study of Volitinib are to evaluate its safety and tolerability in patients with advanced cancer and to determine its maximum tolerated dose. The study will also evaluate Volitinib’s preliminary efficacy against various tumors, including lung cancer and gastric cancer. The c-Met gene amplification status and protein expression level will be used subsequently to direct patient selection.
Professor Michael Millward said: “Volitinib is a novel oral anti-cancer therapy that selectively targets the c-Met signaling pathway. We are excited to conduct this first-in-human Phase I study in Australia and to play an important role in the global efforts of developing this potential personalized new medicine.”
Volitinib is a potent ATP-competitive c-Met inhibitor with high selectivity over a 274 kinase panel. Pre-clinical studies of Volitinib have demonstrated tumor growth inhibitory activity in a series of human tumor xenografts, especially for those tumors with c-Met gene amplification or c-Met over-expression.
About the c-Met Signal pathway
The c-Met (also known as HGFR) signalling pathway has specific roles particularly in normal mammalian growth and development. However, this pathway has been shown to function abnormally in a range of different cancers.
Volitinib is a potent and highly selective c-Met inhibitor, which has been demonstrated to inhibit the growth of tumors in a series of pre-clinical disease models, especially for those tumors with aberrant c-Met signaling such as gene amplification or c-Met over-expression. In addition these biomarkers provide the potential to explore patient selection strategies in later stage clinical trials.