By Josh White
Date: Friday 04 Oct 2019
LONDON (ShareCast) - (Sharecast News) - Hutchison China MediTech, trading as Chi-Med, has initiated an international phase 1 and 1b study of 'HMPL-523' - its novel spleen tyrosine kinase inhibitor - in patients with relapsed or refractory lymphoma, it announced on Friday.
The AIM-traded firm said the first patient was dosed on 26 September in the United States.
It said the international clinical study, with sites in the US and Europe, was a multi-centre, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-523 administered orally to patients with relapsed or refractory lymphoma.
The primary outcome measures were safety and tolerability.
Secondary outcomes included pharmacokinetic measurements and preliminary efficacy such as objective response rate.
"This study complements the ongoing phase 1b dose expansion program of HMPL-523 in Australia and China, addressing a broad range of hematological cancers," the Chi-Med board said in its statement.
"Preliminary results of the dose escalation stage in a phase 1 study in China of HMPL-523 in patients with relapsed or refractory B-cell lymphomas were presented in 2018.
"Outside of oncology, HMPL-523 is in phase 1 study in patients with immune thrombocytopenia in China."
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