Australia Phase I study to report in late 2013
London: Tuesday, 25 June 2013: Chi-Med today announces that Hutchison MediPharma Limited (“HMP”), its majority owned R&D company, 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 commercialisation 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 tumours, 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 tumour 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 tumour growth inhibitory activity in a series of human tumour xenografts, especially for those tumours with c-Met gene amplification or c-Met over-expression.
Christian Hogg, CEO
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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 tumours in a series of pre-clinical disease models, especially for those tumours with aberrant c-Met signalling 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.
HMP is majority owned by Chi-Med.
Chi-Med is the holding company of a healthcare group based primarily in China and was listed on the Alternative Investment Market of the London Stock Exchange in May 2006. It is focused on researching, developing, manufacturing and selling pharmaceuticals and health oriented consumer products.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international company listed on the Main Board of The Stock Exchange of Hong Kong Limited.