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.
Dr. Samantha Du, Chief Scientific Officer of Chi-Med and Chief Executive Officer of Hutchison MediPharma, said: “This clinical trial approval and its initiation mark a major achievement for the oncology R&D organisation at Hutchison MediPharma. Sulfatinib is a highly potent and selective VEGF signalling inhibitor, and we are very pleased that we have advanced this anti-cancer agent into clinical development. There is a clear medical need for more effective and safe anti-angiogenic treatments for cancer.”
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Angiogenesis, the process of developing new blood vessels, is critical for tumour cell growth, survival, invasion and metastasis. The vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFRs) play a pivotal role in tumour-related angiogenesis, and the VEGF/VEGFR pathway is an important target for anti-angiogenic drug development and tumour therapy. Inhibition of VEGF signalling in tumour vasculature therefore represents an exciting therapeutic strategy, with the potential to arrest the development of new blood vessels essential for tumour growth and metastasis. Several anti-VEGF agents have shown efficacy in a range of tumour types.
Sulfatinib is a potent, selective, small molecule tyrosine kinase inhibitor of VEGFs. In vivo, Sulfatinib inhibited the growth of multiple human tumours xenografts in mice.
Hutchison MediPharma is Chi-Med’s wholly-owned drug R&D subsidiary and has a team of well over 200 scientists and staff focusing on discovery and development of botanical drugs, semi-synthetic natural product drugs, and synthetic single chemical entity drugs. Hutchison MediPharma has a pipeline of single new chemical entity projects in both the auto-immune/inflammatory disease and oncology therapeutic areas.
Chi-Med is the holding company of a pharmaceutical and healthcare group based primarily in China and was admitted to trading 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.