On February 14, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated the first-in-human ("FIH") Phase I clinical trial of HMPL-453 in Australia (Press release, Hutchison China MediTech, FEB 14, 2017, http://www.chi-med.com/initiates-fih-trial-of-fgfr-inhibitor-hmpl-453/ [SID1234517720]). HMPL-453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor ("FGFR"). The first drug dose was administered on February 14, 2017. Schedule your 30 min Free 1stOncology Demo! FGFRs are a sub-family of receptor tyrosine kinases. Activation of FGFR signaling pathways is central to several biological processes, including angiogenesis, tissue growth and repair. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as, conferring resistance to anti-tumor therapies. To date, there are no approved therapies specifically targeting the FGFR signaling pathway.
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The FIH dose-escalation trial aims to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HMPL-453 in patients with advanced or metastatic solid malignancies, who have failed or are unable to tolerate standard therapies or for whom no standard therapies exist. This open-label study consists of two preliminary phases, a dose-escalation (stage 1) and a dose-expansion stage (stage 2).
In pre-clinical studies, HMPL-453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02966171.