Research Update
Hutchison China Meditech Limited
23 May 2007
Hutchison China MediTech Limited ('Chi-Med')
(AIM: HCM)
Chi-Med completes patient enrolment on its HMPL-004 ulcerative colitis
proof-of-concept Phase II clinical trial in China
On-track for publication of final results this August
London, Wednesday, 23 May 2007: Chi-Med today announces its wholly-owned drug R&
D subsidiary, Hutchison MediPharma Limited ('Hutchison MediPharma'), has
completed patient enrolment on the proof-of-concept ('POC') Phase II clinical
trial of its HMPL-004 drug candidate in active mild-to-moderate ulcerative
colitis ('UC') patients in China.
Background on the POC Phase II clinical trial
The POC Phase II clinical trial is a multi-center, randomized, double-blind,
active controlled study of 120 patients. In the trial, one dose of HMPL-004
(1,200mg daily) and active control Mesalazine SR were tested. The primary aim
of the clinical trial is to compare HMPL-004 with the safety and efficacy of
current standard therapy of Mesalazine SR in treating active mild-to-moderate UC
patients. Assessments include both a patient's UC clinical symptom score and
the change in the patient's endoscope grade from the start-point to the
end-point of the eight-week treatment. The change in the symptom score is the
primary measure of efficacy for the clinical study. The endoscope grade change
is the secondary efficacy measurement. Safety evaluations are made throughout
the clinical trial period.
Dr. Samantha Du, Chief Scientific Officer of Chi-Med and Managing Director of
Hutchison MediPharma, said:
'We are excited that our HMPL-004 China trial has finished patient recruitment.
The performance of HMPL-004 in this China POC Phase II clinical trial will give
us a clear picture of HMPL-004's future clinical development plan, and encourage
the US Crohn's disease ('CD') trial enrolment.'
Background on HMPL-004
HPML-004 is a traditional botanical extract used in Chinese medicine to treat
inflammatory and infectious diseases. Inflammatory bowel disease ('IBD')
including CD and UC are both considered auto-immune diseases. The patient
population with CD and UC in the US is estimated at between 650,000 and
1,100,000 people with CAGR in the 4% range; the US market alone for CD and UC
therapies is expected to reach US$1.5 billion in 2012. Currently prescribed
therapeutics for IBD include steroids, anti-inflammatory drugs, antibiotics,
immunosuppressive agents and cytokine inhibiting biologicals. These therapies
exhibit varying degrees of clinical benefit. However, they are often associated
with unwanted side effects.
Scientists at Hutchison MediPharma discovered and patented the novel biological
activities of HMPL-004 in suppressing inflammatory cytokine expression in-vitro
and in-vivo, suggesting that HMPL-004 could provide safer and more effective
therapy for IBD patients. HMPL-004 inhibits TNF-alpha and IL-1beta
production in cell-based assays. In addition, HMPL-004 was shown to inhibit NF-
kB activation. NF-kB is a family of transcriptional factors that
regulate a wide spectrum of genes critically involved in host defense and
inflammation. A large number of studies have demonstrated that agents blocking
inflammatory cytokines, including TNF-alpha and IL-1beta, and those
inhibiting NF-kB activation can significantly suppress inflammatory response.
A further POC Phase II clinical trial on HMPL-004 is currently being conducted
in the US to treat CD. Patient enrolment is ongoing and the clinical trial is
expected to complete in 2008.
Mr. Christian Hogg, CEO of Chi-Med, said:
'The HMPL-004 POC Phase II clinical trial is the first that Chi-Med will report
as a listed company and it should be noted that this trial is on time and has
been delivered at lower than expected cost. We are engaged in out licensing
discussions on HMPL-004 and are hopeful that our UC and CD trials will combine
to provide us maximum value.'
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
Yvonne Alexander +44 (0) 7866 610 682
Notes to Editors
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 is focused on
researching, developing, manufacturing, and selling 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 research and development
company and has a team of around 120 scientists and staff focusing on botanical
drugs, semi-synthetic natural product drugs, and synthetic single chemical
entity drugs. It currently has two candidates in clinical development in both
the US and China. HMPL-002, a radiosensitiser for head and neck 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, for treatment of
inflammatory bowel diseases, including Crohn's Disease and Ulcerative Colitis,
is in Phase II in the US and in proof-of-concept in China. Hutchison MediPharma
also has a pipeline of single molecular entity discovery projects in the
auto-immune/inflammatory diseases and oncology therapeutic areas which have
shown activity against clinically validated targets.
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