Receives SFDA IND Approval and Begins Phase I Clinical Trial of Sulfatinib for the Treatment of Cancer
Shanghai: Thursday, May 6, 2010: Hutchison MediPharma had earlier announced 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 regulatory authorities in China. The investigational new drug application (“IND”) was reviewed through the State Food and Drug Administration’s (SFDA) Green Channel expedited application process. The first patients were dosed on April 28.
Sulfatinib (HMPL-012) is a novel small molecule that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factors receptors (VEGFR) and fibroblast growth factor receptor (FGFR). 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 tumors. The secondary objectives include the assessment of single and multiple dose pharmacokinetics and the evaluation of Sulfatinib’s antitumor activity.
Dr. Samantha Du, Chief Executive Officer of Hutchison MediPharma, said: “This clinical trial approval and its initiation mark a major achievement for the oncology R&D organization at Hutchison MediPharma. Sulfatinib is a highly potent and selective VEGF signaling 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.”
About the Vascular Endothelial Growth Factor Signaling Pathway in Tumor
Angiogenesis, the process of developing new blood vessels, is critical for tumor cell growth, survival, invasion and metastasis. As tumor growing, it can produce vascular endothelial growth factor (VEGF) and other growth factors. VEGF can bind its receptor VEGFR on endothelial cells and stimulate new blood vessel formation, which will provide nutrients for tumor growth. Anti-angiogenesis or blocking new blood vessel formation by inhibiting VEGF signaling pathway is considered as one of promising approach against cancer. In clinical, several anti-VEGFR agents have shown efficacy in a range of tumor types.
Sulfatinib is a potent, selective, small molecule VEGFR/FGFR dual inhibitor. In vivo, Sulfatinib inhibited the growth of multiple human tumors xenografts in mice.
