Hutchmed Regulatory News (HCM)

29 Feb 2008 07:00

Hutchison China Meditech Limited29 February 2008 Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) Chi-Med Announces Start of Patient Enrolment in a Global Phase IIb UlcerativeColitis Clinical Trial of HMPL-004, its Leading Anti-Inflammatory Drug Candidate London, Friday, 29 February 2008: Chi-Med today announces its wholly-owned drugR&D subsidiary, Hutchison MediPharma Limited ("Hutchison MediPharma"), hasenrolled the first patient into its global Phase IIb trial programme assessingHMPL-004 in patients with mild-to-moderate Ulcerative Colitis ("UC"), a form ofinflammatory bowel disease. This patient was screened and randomized per thestudy protocol at one of its clinical sites in the United States ("US"). Theglobal clinical trial programme has been designed to further test the drugcandidate's efficacy, assess its safety profile in a broader patient populationand to evaluate different dose regimens in preparation for the Phase III trialswith HMPL-004. The global Phase IIb UC trial will be conducted in approximately50 clinical study centres worldwide including sites in North America and Europe.In July 2007, Chi-Med announced positive results from a Phase IIproof-of-concept study conducted by Hutchison MediPharma with HMPL-004 in UCpatients 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 activemild-to-moderate UC. The patients will be randomized into one of the twoHMPL-004 treatment arms, 1200mg/daily or 1800mg/daily, or the placebo arm. Theprimary endpoint of the trial is to assess the efficacy of HMPL-004 as comparedwith the placebo after eight weeks treatment. In the trial the efficacy ofHMPL-004 will be assessed based on quantitative symptom reduction thresholdsusing the standard Mayo score as well as a rectal bleeding score derived from acolonoscopic examination. Secondary endpoints of the trial involve the clinicalremission, mucosal healing, and the dose response trend of the two HMPL-004treatment arms. Safety evaluations will be made throughout the trial period. Itis anticipated that patient recruitment in this global clinical trial will becompleted by third quarter 2009. HMPL-004, the leading candidate of Chi-Med's drug pipeline for treatinginflammatory bowel disease, is also being assessed as a potential treatment forCrohn's Disease ("CD"). The product candidate is in a Phase II clinical trial inthe US which is actively recruiting patients and Chi-Med anticipates thecompletion of patient recruitment for this CD study by the end of 2008. Dr. Samantha Du, Chief Scientific Officer for Chi-Med and CEO of HutchisonMediPharma, commenting on today's announcement said, "The start of the globalPhase IIb trial with HMPL-004 in patients with Ulcerative Colitis is anothermilestone for Hutchison MediPharma. This study is designed to build on thepositive Phase II results that we have generated in China and to provide us withthe 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, thatHMPL-004 has the potential to become an important treatment of both UlcerativeColitis and Crohn's Disease." HMPL-004 is an orally active, proprietary botanical product that acts onmultiple targets in the pathogenesis of inflammation. It is a compound extractedfrom a Chinese herb that has extensive history of use in China and South EastAsia against respiratory infections and inflammation. Chi-Med's extensivepreclinical work with HMPL-004 has shown that it acts on multiple cellulartargets in the inflammatory signal transduction pathways resulting in suppressedinflammation cytokine expression including TNF-alpha, IL-1 beta and IL-6. Incell based assays, HMPL-004 has demonstrated its ability to inhibit TNF-alphaand IL-1 beta production and to inhibit NF-kB activation. The novel mechanism ofaction of HMPL-004, compared to current conventional therapies, includingmesalazine, could allow it to be used in a broader patient population withinflammatory 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 focusedon Traditional Chinese Medicine (TCM) based primarily in China and was admittedto trading on the Alternative Investment Market of the London Stock Exchange inMay 2006. Chi-Med operates three core business segments: 1) China healthcare -the manufacture, distribution and marketing of pharmaceuticals and healthsupplements in China; 2) Drug R&D - the discovery and global development ofnovel drug in the oncology and auto-immune therapeutic areas; and 3) Consumerproducts - global retailing and distribution consumer health and personal careproducts derived from TCM and botanical ingredients. Chi-Med is majority owned by Hutchison Whampoa Limited, an internationalcorporation 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