Enrolment of HMPL-004 Phase I

RNS Number : 4380W

Hutchison China Meditech Limited

29 July 2009

 



Hutchison China MediTech Limited ('Chi-Med')

(AIM: HCM)

Patient Enrolment Completed Ahead of Schedule for the Global Phase IIb Ulcerative Colitis Trial of HMPL-004

London: Wednesday, 29 July 2009: Hutchison MediPharma Limited ('Hutchison MediPharma'), the wholly-owned drug R&D subsidiary of Chi-Med, today announces the completion well ahead of schedule of patient enrolment into a Phase IIb trial of HMPL-004 in patients with mild-to-moderate Ulcerative Colitis ('UC'), a form of inflammatory bowel disease (IBD). Results from this trial are now expected to be available in the fourth quarter of this year. 

Today's announcement follows both the positive results for HMPL-004's Phase II proof-of-concept study conducted in UC patients in China, announced in July 2007, and the recent encouraging results of HMPL-004's Phase II trial in Crohn's Disease in the US and Ukraine, announced on 13 July this year.

The global Phase IIb UC clinical trial has been designed to further test the drug candidate's efficacy and safety profiles in a broad patient population and different dose levels in preparation for the Phase III registration trials. The patient recruitment of the global UC trial involved some 50 clinical study centres worldwide including sites in North America and Europe. 

The global phase IIb UC trial is a multi-center, randomized, double-blind and placebo-controlled clinical study of 210 patients with active mild-to-moderate UC. In the trial, the patients are enrolled and randomized into one of the HMPL-004 treatment arms, 1200mg/daily or 1800mg/daily, or the placebo arm. The primary trial objective is the efficacy of HMPL-004 in clinical response as compared with the placebo after 8 weeks treatment. The clinical response is defined by quantitative symptom reduction thresholds using the standard Mayo score, along with the rectal bleeding score from the colonoscopic examination. Secondary end points of the trial involve the clinical remission, mucosal healing, and the dose response trend of the two treatment arms. Safety evaluations will be made throughout the trial period.

HMPL-004 is an orally administrated, proprietary botanical product that acts on multiple targets in the pathogenesis of inflammation. It is extracted from a Chinese herb that has extensive history of use in China and South East Asia against respiratory infections and inflammation.  

Hutchison MediPharma's extensive preclinical work 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 IBD patient population.

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Enquiries

Chi-Med Christian Hogg, CEO	Telephone: [phone]
Citigate Dewe Rogerson Anthony Carlisle David Dible	Telephone: [phone] [phone] [phone]

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. It 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 R&D subsidiary and has a team of around 200 scientists and staff focusing on discovery and development of botanical drugs, semi-synthetic natural product drugs, and synthetic single chemical entity drugs. Hutchison MediPharma has a pipeline of single new chemical entity discovery projects in both the auto-immune/inflammatory disease and oncology therapeutic areas.

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.

 

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