LONDON--(BUSINESS WIRE)--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 hematological 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 signaling. Preparations and site selection began in late 2015 and the first patient was dosed on January 13, 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 hematological 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 characterization of the pharmacokinetics of HMPL-523 and its metabolites, and to make preliminary assessments of the anti-tumor 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 hematological malignancies could provide clinical proof-of-concept that modulation of the B-cell signaling pathway through inhibition of Syk will provide patients with a clinical benefit.
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
This announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events, including its plans to initiate clinical studies for its drug candidates in the targeted indications, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrolment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.