Research Update
Hutchison China Meditech Limited
22 November 2007
For Immediate Release
Hutchison China MediTech Limited ('Chi-Med')
(AIM: HCM)
Chi-Med Plans to Initiate Global Phase IIb Trials of
its Lead Anti-Inflammatory Drug Candidate, HMPL-004,
in Ulcerative Colitis Patients
London, Thursday, 22 November 2007: Chi-Med, the Hutchison Whampoa backed
pharmaceutical and healthcare Group, today announces that it's wholly-owned drug
R&D subsidiary, Hutchison MediPharma Limited ('Hutchison MediPharma'), has
obtained clearance for its new Investigative New Drug ('IND') application from
the US Food and Drug Administration for its drug candidate, HMPL-004. The IND
will allow Hutchison MediPharma to commence a planned global Phase IIb trial
with HMPL-004 in patients with mild-to-moderate Ulcerative Colitis ('UC'), a
form of inflammatory bowel disease. This clinical trial has been designed to
assess the drug candidate's efficacy and safety profile in a broad patient
population. Data from this study will be used to guide the design of the
planned Phase III global registration trials with HMPL-004. In July 2007,
Hutchison MediPharma announced a positive Phase II proof-of-concept study with
HMPL-004 in mild-to-moderate UC patients, which was conducted in China.
The global Phase IIb trial is a multi-centre, randomised, double-blind, and
placebo-controlled clinical study of 210 patients with active mild-to-moderate
UC. Patients will be enrolled and randomised into one of the HMPL-004 treatment
arms that will receive either 1,200mg or 1,800mg of the active drug per day, or
placebo. The primary endpoint of the trial will assess the efficacy of HMPL-004
compared with placebo after eight weeks treatment. Secondary endpoints of the
trial involve clinical remission, mucosal healing, and the dose response trend
of the two treatment arms. Safety evaluations will be made throughout the trial
period. The global Phase IIb trial in UC will be conducted in approximately 50
clinical study centres worldwide including sites in North America and Europe.
Separately, HMPL-004, the leading candidate of Chi-Med's drug pipeline for
treating inflammatory bowl disease, is in Phase II clinical trial in the US for
Crohn's Disease. The trial is actively recruiting patients and Chi-Med
anticipates reporting results by late next year.
Dr. Samantha Du, Chief Scientific Officer for Chi-Med and Managing Director of
Hutchison MediPharma, said:
'We are pleased to initiate a global multi-centre Phase IIb trial of HMPL-004
for Ulcerative Colitis disease. Based on the promising results generated from
the Phase
II proof-of-concept study in China and the candidate's novel mechanism of
action, we believe that HMPL-004 has significant potential to provide an
alternative and effective oral treatment to patients worldwide who suffer from
Ulcerative Colitis, a chronic, painful and frequently recurring disease. This
global trial reflects our strong belief in HMPL-004 as a viable drug candidate
for the world market'.
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Enquiries
Chi-Med Telephone: +852 2121 8200
Christian Hogg, CEO
Citigate Dewe Rogerson Telephone: +44 (0) 20 7638 9571
Anthony Carlisle Mobile: +44 (0) 7973 611 888
Yvonne Alexander Mobile: +44 (0) 7866 610 682
About Chi-Med
Chi-Med is the holding company of a pharmaceutical and healthcare group based
primarily in China and was admitted to trading on the Alternative Investment
Market of the London Stock Exchange in May 2006. Chi-Med focuses on research,
development, manufacture and sale of pharmaceuticals, health supplements and
other consumer health and personal care products derived from Traditional
Chinese Medicine and botanical ingredients.
Hutchison MediPharma is Chi-Med's wholly-owned drug R&D subsidiary and has at
its disposal a team of around 140 scientists and staff focusing on discovery and
development of botanical drugs, semi-synthetic natural product drugs, and
synthetic single chemical entity drugs. Hutchison MediPharma currently has two
candidates in clinical development in both the US and China. HMPL-002, a
radiosensitiser for head and neck cancer and non-small cell lung cancer, is in
Phase I/II in the US and in proof-of-concept in China. HMPL-004, an inhibitor to
a group of inflammatory cytokines, has completed the Phase II proof-of-concept
study in Ulcerative Colitis and is in Phase II studies in Crohn's Disease in the
US. Hutchison MediPharma also has a pipeline of single new chemical entity
discovery projects in auto-immune/inflammatory diseases and oncology therapeutic
areas.
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.
About HMPL-004
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 HMPL-004 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.
HMPL-004 was demonstrated to inhibit TNF-alpha and IL-1 beta production in
cell-based assays and is also able to inhibit NF-kB activation. The novel
mechanism of action of HMPL-004, compared to current conventional therapies,
including Mesalazine, allows it to access a unique patient population. HMPL-004
is currently also in Phase II trial in the US for the treatment of Crohn's
Disease and has completed a Phase II proof-of-concept trial in mild-to-moderate
Ulcerative Colitis in China.
This information is provided by RNS
The company news service from the London Stock Exchange