Hutchison China Medi (HCM) - Phase I trial with EGFR inhibitor theliatinib
RNS Number : 9475P
Hutchison China Meditech Limited
01 November 2012
Hutchison China MediTech Limited ("Chi-Med")
Hutchison MediPharma Limited initiates Phase I clinical study
with its novel EGFR inhibitor Theliatinib
London: Thursday, 1 November 2012: Chi-Med announced that Hutchison MediPharma
Limited ("HMP"), its majority owned R&D company, initiated the first-in-human
Phase I clinical trial of Theliatinib (HMPL-309). This is the fourth oncology
compound from the internal discovery programmes of HMP to enter into clinical
development in China. Theliatinib is a novel, orally active small molecule
inhibitor targeting the wild type epidermal growth factor receptor ("EGFR") or
resistant EGFR tumours. The first patient was dosed on 30 October 2012.
The primary objectives of the Phase I study are to evaluate its safety and
tolerability in patients with advanced solid tumours and to determine its
maximum tolerated dose. This study will also evaluate its preliminary
efficacy against non-small cell lung cancer ("NSCLC"), determine the
pharmacokinetics of 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. Theliatinib was also found to have good pharmacokinetic properties
and a favourable safety profile. 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,"
said Christian Hogg, Chief Executive Officer of Chi-Med.
Chi-Med Telephone: +852 2121 8200
Christian Hogg, CEO
Citigate Dewe Rogerson Telephone: +44 20 7638 9571
Anthony Carlisle Mobile: +44 7973 611 888
David Dible Mobile: +44 7967 566 919
Panmure Gordon (UK) Limited Telephone: +44 20 7614 8383
Notes to Editors
About epidermal growth factor receptor ("EGFR") and non-small cell lung cancer
EGFR is a protein that is a cell-surface receptor for epidermal growth
factors. Activation of EGFR can lead to a series of downstream signalling
activities that mediate tumour cell proliferation and the suppression of cell
death. Small molecule tyrosine kinase inhibitors of EGFR block these signals,
limiting tumour cell growth and survival.
The estimated incidence of lung cancer worldwide was over 1.6 million in 2008,
with over 520,000 cases in China. Lung cancer is the most common cancer both
worldwide and in China.
Gefitinib (Iressa™) and erlotinib (Tarceva™), first generation small molecule
EGFR inhibitors, are used to treat NSCLC, particularly in patients with EGFR
sensitive mutations. Worldwide sales of Tarceva™ alone reached approximately
US$1.4 billion in 2011. However, EGFR mutations generally occur in 10-30% of
NSCLC patients, with the range differing slightly by region. Currently
available EGFR inhibitors have been shown to be less effective in treating
patients carrying the wild type EGFR compared to treating patients harbouring
EGFR activating mutations. Pre-clinical studies suggest that Theliatinib has
potential in the treatment of NSCLC patients with wild type EGFR or resistance
to gefitinib or erlotinib.
HMP is a novel drug R&D company focusing on discovering, developing and
commercialising innovative therapeutics in oncology and autoimmune diseases.
With a team of around 200 scientists and staff, its pipeline is comprised of
novel oral compounds for cancer and inflammation in development in North
America, Europe, Australia and Greater China.
HMP is majority owned by Chi-Med.
Chi-Med is the holding company of a healthcare group based primarily in China
and was listed on the Alternative Investment Market of the London Stock
Exchange in May 2006. It is focused on researching, developing, manufacturing
and selling pharmaceuticals and health oriented consumer products.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international
company listed on the Main Board of The Stock Exchange of Hong Kong Limited.
This information is provided by RNS
The company news service from the London Stock Exchange
MSCBFLFXLBFLFBF -0- Nov/01/2012 07:00 GMT
Press spacebar to pause and continue. Press esc to stop.