Shanghai: Tuesday, June 25, 2013: Hutchison MediPharma (“HMP”) today announces that it has initiated the Phase I clinical trial of Volitinib (HMPL-504) in China, which entitles HMP to receive a cash milestone payment of US$5 million pursuant to the global licensing, co-development and commercialization agreement entered into between AstraZeneca PLC and HMP in December 2011.
The primary objectives of the Phase I study of Volitinib in China are to evaluate its safety and tolerability in patients in China 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, both being major unmet medical needs in China. The c-Met gene amplification status and protein expression levels will be evaluated to help inform subsequent patient selection strategies
In February 2012, HMP commenced the first-in-human Phase I clinical trial of Volitinib in Australia which has progressed well through multiple dose levels and continues as a study of safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy against multiple tumor types, particularly among Caucasian patients. Results of the Phase I trial in Australia are expected in late 2013. Furthermore, the Phase I trial in Australia provides a guide for the selection of the recommended starting dose for the Phase I study in China.
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 and Volitinib
The c-Met (also known as HGFR) signaling 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.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.