Hutchison China Meditech Limited
29 February 2008
Hutchison China MediTech Limited ('Chi-Med')
(AIM: HCM)
Chi-Med Announces Start of Patient Enrolment in a Global Phase IIb Ulcerative
Colitis Clinical Trial of HMPL-004, its Leading Anti-Inflammatory Drug Candidate
London, Friday, 29 February 2008: Chi-Med today announces its wholly-owned drug
R&D subsidiary, Hutchison MediPharma Limited ('Hutchison MediPharma'), has
enrolled the first patient into its global Phase IIb trial programme assessing
HMPL-004 in patients with mild-to-moderate Ulcerative Colitis ('UC'), a form of
inflammatory bowel disease. This patient was screened and randomized per the
study protocol at one of its clinical sites in the United States ('US'). The
global clinical trial programme has been designed to further test the drug
candidate's efficacy, assess its safety profile in a broader patient population
and to evaluate different dose regimens in preparation for the Phase III trials
with HMPL-004. The global Phase IIb UC trial will be conducted in approximately
50 clinical study centres worldwide including sites in North America and Europe.
In July 2007, Chi-Med announced positive results from a Phase II
proof-of-concept study conducted by Hutchison MediPharma with HMPL-004 in UC
patients in China.
The global Phase IIb UC trial is a multi-center, randomized, double-blind,
placebo-controlled clinical study which will recruit 210 patients with active
mild-to-moderate UC. The patients will be randomized into one of the two
HMPL-004 treatment arms, 1200mg/daily or 1800mg/daily, or the placebo arm. The
primary endpoint of the trial is to assess the efficacy of HMPL-004 as compared
with the placebo after eight weeks treatment. In the trial the efficacy of
HMPL-004 will be assessed based on quantitative symptom reduction thresholds
using the standard Mayo score as well as a rectal bleeding score derived from a
colonoscopic examination. Secondary endpoints of the trial involve the clinical
remission, mucosal healing, and the dose response trend of the two HMPL-004
treatment arms. Safety evaluations will be made throughout the trial period. It
is anticipated that patient recruitment in this global clinical trial will be
completed by third quarter 2009.
HMPL-004, the leading candidate of Chi-Med's drug pipeline for treating
inflammatory bowel disease, is also being assessed as a potential treatment for
Crohn's Disease ('CD'). The product candidate is in a Phase II clinical trial in
the US which is actively recruiting patients and Chi-Med anticipates the
completion of patient recruitment for this CD study by the end of 2008.
Dr. Samantha Du, Chief Scientific Officer for Chi-Med and CEO of Hutchison
MediPharma, commenting on today's announcement said, 'The start of the global
Phase IIb trial with HMPL-004 in patients with Ulcerative Colitis is another
milestone for Hutchison MediPharma. This study is designed to build on the
positive Phase II results that we have generated in China and to provide us with
the data we need to design our Phase III clinical trial programme. We believe,
based on our clinical experience to-date and its unique mode of action, that
HMPL-004 has the potential to become an important treatment of both Ulcerative
Colitis and Crohn's Disease.'
HMPL-004 is an orally active, proprietary botanical product that acts on
multiple targets in the pathogenesis of inflammation. It is a compound extracted
from a Chinese herb that has extensive history of use in China and South East
Asia against respiratory infections and inflammation. Chi-Med's extensive
preclinical work with HMPL-004 has shown that it acts on multiple cellular
targets in the inflammatory signal transduction pathways resulting in suppressed
inflammation cytokine expression including TNF-alpha, IL-1 beta and IL-6. In
cell based assays, HMPL-004 has demonstrated its ability to inhibit TNF-alpha
and IL-1 beta production and to inhibit NF-kB activation. The novel mechanism of
action of HMPL-004, compared to current conventional therapies, including
mesalazine, could allow it to be used in a broader patient population with
inflammatory bowel disease.
Ends
Enquiries
Chi-Med Telephone: +852 2121 8200
Christian Hogg, CEO
Citigate Dewe Rogerson Telephone: +44 (0) 20 7638 9571
Anthony Carlisle +44 (0) 7973 611 888
David Dible +44 (0) 7967 566 919
About Chi-Med
Chi-Med is the holding company of a pharmaceutical and healthcare group focused
on Traditional Chinese Medicine (TCM) based primarily in China and was admitted
to trading on the Alternative Investment Market of the London Stock Exchange in
May 2006. Chi-Med operates three core business segments: 1) China healthcare -
the manufacture, distribution and marketing of pharmaceuticals and health
supplements in China; 2) Drug R&D - the discovery and global development of
novel drug in the oncology and auto-immune therapeutic areas; and 3) Consumer
products - global retailing and distribution consumer health and personal care
products derived from TCM and botanical ingredients.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international
corporation 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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