Hutchison initiates phase 1 on Theliatinib trial

published 1 November 2012

Pharmaceutical company Hutchison China MediTech (Chi-MEd) has announced that through its majority-owned research and development company it has initiated the first-in-human phase 1 clinical trial of its Theliatinib (HMPL-309) product.

The firm said the main aim of the study is to evaluate its safety and tolerability in patients with advanced solid tumours and to determine its maximum tolerated dose.

The trial is the fourth oncology compound from the internal discovery programmes the R&D company to enter into clinical development in China.

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Theliatinib is an orally active product which targets the wild type epidermal growth factor receptor (EGFR) or resistant EGFR tumours.

Phase 1 will also evaluate its preliminary efficacy against non-small cell lung cancer (NSCLC), determine the way the body responds to Theliatinib under single dose and repeat doses and explore the relationship between the Theliatinib's activity and certain biomarkers.

"In pre-clinical studies, Theliatinib demonstrated strong anti-tumour activity against EGFR wild type tumours at doses that are expected to be well tolerated," the company said.

"These studies also exhibited good tissue distribution and stronger anti-tumour activity in EGFR wild type and EGFR resistant tumours, compared with first generation small molecule EGFR inhibitors. If these attributes are also demonstrated in clinical studies, we believe that Theliatinib could become an important therapy in this area."