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news.Hutchison MediPharma, the wholly-owned drug R&D subsidiary of Chi-Med, has received approval from SFDA in China for the Phase I clinical trial of its anti-cancer drug candidate, Sulfatinib.
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The investigational new drug application (IND) was reviewed through SFDA’s Green Channel expedited application process. The first patients were dosed on April 28, 2010.
Sulfatinib (HMPL-012) is a small molecule that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factors (VEGFs) and Fibroblast Growth Factor (FGF) receptors.
Sulfatinib was discovered and developed internally by Hutchison MediPharma. According to the study, Sulfatinib is a potent suppressor of angiogenesis, an established approach in anti-cancer treatment. The study indicated that it is generally well tolerated in animals.
The Phase I clinical study is being conducted in China. The trial is an open-label, dose-escalation study.
Hutchison MediPharma added that 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.
Samantha Du, chief scientific officer of Chi-Med and CEO of Hutchison MediPharma, said: “This clinical trial approval and its initiation mark an achievement for the oncology R&D organisation at Hutchison MediPharma. Sulfatinib is a selective VEGF signalling inhibitor, and we are 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.”