Hutchmed Regulatory News (HCM)

22 Nov 2007 07:03

Hutchison China Meditech Limited22 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 backedpharmaceutical and healthcare Group, today announces that it's wholly-owned drugR&D subsidiary, Hutchison MediPharma Limited ("Hutchison MediPharma"), hasobtained clearance for its new Investigative New Drug ("IND") application fromthe US Food and Drug Administration for its drug candidate, HMPL-004. The INDwill allow Hutchison MediPharma to commence a planned global Phase IIb trialwith HMPL-004 in patients with mild-to-moderate Ulcerative Colitis ("UC"), aform of inflammatory bowel disease. This clinical trial has been designed toassess the drug candidate's efficacy and safety profile in a broad patientpopulation. Data from this study will be used to guide the design of theplanned Phase III global registration trials with HMPL-004. In July 2007,Hutchison MediPharma announced a positive Phase II proof-of-concept study withHMPL-004 in mild-to-moderate UC patients, which was conducted in China. The global Phase IIb trial is a multi-centre, randomised, double-blind, andplacebo-controlled clinical study of 210 patients with active mild-to-moderateUC. Patients will be enrolled and randomised into one of the HMPL-004 treatmentarms that will receive either 1,200mg or 1,800mg of the active drug per day, orplacebo. The primary endpoint of the trial will assess the efficacy of HMPL-004compared with placebo after eight weeks treatment. Secondary endpoints of thetrial involve clinical remission, mucosal healing, and the dose response trendof the two treatment arms. Safety evaluations will be made throughout the trialperiod. The global Phase IIb trial in UC will be conducted in approximately 50clinical study centres worldwide including sites in North America and Europe. Separately, HMPL-004, the leading candidate of Chi-Med's drug pipeline fortreating inflammatory bowl disease, is in Phase II clinical trial in the US forCrohn's Disease. The trial is actively recruiting patients and Chi-Medanticipates reporting results by late next year. Dr. Samantha Du, Chief Scientific Officer for Chi-Med and Managing Director ofHutchison MediPharma, said: "We are pleased to initiate a global multi-centre Phase IIb trial of HMPL-004for Ulcerative Colitis disease. Based on the promising results generated fromthe Phase II proof-of-concept study in China and the candidate's novel mechanism ofaction, we believe that HMPL-004 has significant potential to provide analternative and effective oral treatment to patients worldwide who suffer fromUlcerative Colitis, a chronic, painful and frequently recurring disease. Thisglobal trial reflects our strong belief in HMPL-004 as a viable drug candidatefor the world market". - Ends - 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 basedprimarily in China and was admitted to trading on the Alternative InvestmentMarket of the London Stock Exchange in May 2006. Chi-Med focuses on research,development, manufacture and sale of pharmaceuticals, health supplements andother consumer health and personal care products derived from TraditionalChinese Medicine and botanical ingredients. Hutchison MediPharma is Chi-Med's wholly-owned drug R&D subsidiary and has atits disposal a team of around 140 scientists and staff focusing on discovery anddevelopment of botanical drugs, semi-synthetic natural product drugs, andsynthetic single chemical entity drugs. Hutchison MediPharma currently has twocandidates in clinical development in both the US and China. HMPL-002, aradiosensitiser for head and neck cancer and non-small cell lung cancer, is inPhase I/II in the US and in proof-of-concept in China. HMPL-004, an inhibitor toa group of inflammatory cytokines, has completed the Phase II proof-of-conceptstudy in Ulcerative Colitis and is in Phase II studies in Crohn's Disease in theUS. Hutchison MediPharma also has a pipeline of single new chemical entitydiscovery projects in auto-immune/inflammatory diseases and oncology therapeuticareas. Chi-Med is majority owned by Hutchison Whampoa Limited, an internationalcorporation 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 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 HMPL-004 acts on multiple cellulartargets in the inflammatory signal transduction pathways resulting in suppressedinflammation cytokine expression including TNF-alpha, IL-1 beta and IL-6.HMPL-004 was demonstrated to inhibit TNF-alpha and IL-1 beta production incell-based assays and is also able to inhibit NF-kB activation. The novelmechanism of action of HMPL-004, compared to current conventional therapies,including Mesalazine, allows it to access a unique patient population. HMPL-004is currently also in Phase II trial in the US for the treatment of Crohn'sDisease and has completed a Phase II proof-of-concept trial in mild-to-moderateUlcerative Colitis in China. This information is provided by RNS The company news service from the London Stock Exchange