London: Friday, 15 January 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated a Phase I trial in Australia in patients with haematological malignancies. HMPL‑523 is a novel, highly selective and potent small molecule oral inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. Preparations and site selection began in late 2015 and the first patient was dosed on 13 January 2016. This trial follows the successful completion of a first-in-human Phase I clinical trial in healthy volunteers in October 2015.
The new study is a Phase I, open-label, dose escalation study of HMPL‑523 as monotherapy administered orally to patients with relapsed or refractory haematological malignancies who are unable to tolerate standard therapy or for whom there is no effective therapy. Two stages for this study are planned: a dose escalation stage and a dose-expansion stage. The primary objectives of the study are to evaluate safety and tolerability, and to determine the maximum tolerated dose and/or recommended Phase II dose of HMPL‑523 in this patient population. Other objectives include the evaluation and characterisation of the pharmacokinetics of HMPL‑523 and its metabolites, and to make preliminary assessments of the anti-tumour activity of HMPL‑523 in certain sub-populations in the dose expansion phase of the trial.
The successful completion of the first-in-human study in healthy volunteers in 2015 has established the safety profile of HMPL‑523. HMP now hopes that this Phase I study in haematological malignancies could provide clinical proof-of-concept that modulation of the B-cell signalling pathway through inhibition of Syk will provide patients with a clinical benefit.