Hutchison China Medi HCM Phase I trial with EGFR inhibitor theliatinib

  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")
                                  (AIM: HCM)

        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

Richard Gray

Andrew Potts

Grishma Patel

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.

About HMP

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.

About 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


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