London: Friday, 30 April 2010: Hutchison MediPharma Limited (“Hutchison MediPharma”), the wholly-owned drug R&D subsidiary of Chi-Med, today announces that it has initiated the first-in-human Phase I clinical trial of its anti-cancer drug candidate, Sulfatinib, after it received approval from the State Food and Drug Administration (“SFDA”) in China. The investigational new drug application (“IND”) was reviewed through SFDA’s Green Channel expedited application process. The first patients were dosed on 28 April 2010.
Sulfatinib (HMPL-012) is a novel small molecule that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factors (VEGFs) and fibroblast growth factor (FGF) receptors. Pre-clinical data shows that this compound is a potent suppressor of angiogenesis, an established approach in anti-cancer treatment. It also indicated that it is generally well tolerated in animals. Sulfatinib was discovered and developed internally by Hutchison MediPharma.
The Phase I clinical study is being conducted in China. The trial is an open-label, dose-escalation study. The primary objective of the trial is to estimate the maximum tolerated dose (MTD) and assess the safety and tolerability in patients with advanced solid tumours. The secondary objectives include the assessment of single and multiple dose pharmacokinetics and the evaluation of Sulfatinib’s antitumor activity.