14th Feb 2017 07:47
LONDON (Alliance News) - Hutchinson China MediTech Ltd on Tuesday said it has initiated the first in-human phase I clinical trial in Australia of its novel inhibitor targeting fibroblast growth factor receptor and said it will also be presenting data from a separate trial in the US later this week.
Hutchnson MediTech said the first drug dose under the in-human trial of the novel inhibitor HMPL-453 was administered on Tuesday.
The novel inhibitor targets fibroblast growth factor receptors (FGFRs), a sub-family of receptor tyrosine kinases. Activation of FGFR signalling 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 signalling 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 signalling pathway," said Hutchinson.
The in-human, 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.
"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 favourable safety profile," said Hutchinson.
In a separate statement on Tuesday, the company said it will be present data with partner AstraZeneca PLC from the ongoing phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, to be held in Orlando, Florida, US.
The symposium will start this Thursday and end on Saturday.
Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.
Papillary renal cell carcinoma, the second most common histologic subtype of renal cell carcinoma, is associated with alterations in the c-Met gene, such as mutations, amplifications and/or chromosomal changes.
"Therapies that are currently available for renal cell carcinoma patients have demonstrated only modest benefit in papillary renal cell carcinoma and there are no therapies specifically approved for the treatment of c-Met-driven papillary renal cell carcinoma. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy," said Hutchinson.
By Joshua Warner; [email protected]; @JoshAlliance
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