Hutchmed Regulatory News (HCM)

23 May 2007 07:00

Hutchison China Meditech Limited23 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"), hascompleted patient enrolment on the proof-of-concept ("POC") Phase II clinicaltrial of its HMPL-004 drug candidate in active mild-to-moderate ulcerativecolitis ("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 aimof the clinical trial is to compare HMPL-004 with the safety and efficacy ofcurrent standard therapy of Mesalazine SR in treating active mild-to-moderate UCpatients. Assessments include both a patient's UC clinical symptom score andthe change in the patient's endoscope grade from the start-point to theend-point of the eight-week treatment. The change in the symptom score is theprimary measure of efficacy for the clinical study. The endoscope grade changeis the secondary efficacy measurement. Safety evaluations are made throughoutthe clinical trial period. Dr. Samantha Du, Chief Scientific Officer of Chi-Med and Managing Director ofHutchison 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 giveus a clear picture of HMPL-004's future clinical development plan, and encouragethe US Crohn's disease ("CD") trial enrolment." Background on HMPL-004 HPML-004 is a traditional botanical extract used in Chinese medicine to treatinflammatory and infectious diseases. Inflammatory bowel disease ("IBD")including CD and UC are both considered auto-immune diseases. The patientpopulation with CD and UC in the US is estimated at between 650,000 and1,100,000 people with CAGR in the 4% range; the US market alone for CD and UCtherapies is expected to reach US$1.5 billion in 2012. Currently prescribedtherapeutics for IBD include steroids, anti-inflammatory drugs, antibiotics,immunosuppressive agents and cytokine inhibiting biologicals. These therapiesexhibit varying degrees of clinical benefit. However, they are often associatedwith unwanted side effects. Scientists at Hutchison MediPharma discovered and patented the novel biologicalactivities of HMPL-004 in suppressing inflammatory cytokine expression in-vitroand in-vivo, suggesting that HMPL-004 could provide safer and more effectivetherapy for IBD patients. HMPL-004 inhibits TNF-alpha and IL-1betaproduction in cell-based assays. In addition, HMPL-004 was shown to inhibit NF-kB activation. NF-kB is a family of transcriptional factors thatregulate a wide spectrum of genes critically involved in host defense andinflammation. A large number of studies have demonstrated that agents blockinginflammatory cytokines, including TNF-alpha and IL-1beta, and thoseinhibiting NF-kB activation can significantly suppress inflammatory response. A further POC Phase II clinical trial on HMPL-004 is currently being conductedin the US to treat CD. Patient enrolment is ongoing and the clinical trial isexpected 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 reportas a listed company and it should be noted that this trial is on time and hasbeen delivered at lower than expected cost. We are engaged in out licensingdiscussions on HMPL-004 and are hopeful that our UC and CD trials will combineto provide us maximum value." Ends Enquiries Chi-Med Telephone: +852 2121 8200Christian Hogg, CEO Citigate Dewe Rogerson Telephone: +44 (0) 20 7638 9571 Anthony Carlisle +44 (0) 7973 611 888Yvonne Alexander +44 (0) 7866 610 682 Notes to Editors 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 is focused onresearching, developing, manufacturing, and selling pharmaceuticals, healthsupplements and other consumer health and personal care products derived fromTraditional Chinese Medicine and botanical ingredients. Hutchison MediPharma is Chi-Med's wholly-owned drug research and developmentcompany and has a team of around 120 scientists and staff focusing on botanicaldrugs, semi-synthetic natural product drugs, and synthetic single chemicalentity drugs. It currently has two candidates in clinical development in boththe US and China. HMPL-002, a radiosensitiser for head and neck and non-smallcell 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 ofinflammatory bowel diseases, including Crohn's Disease and Ulcerative Colitis,is in Phase II in the US and in proof-of-concept in China. Hutchison MediPharmaalso has a pipeline of single molecular entity discovery projects in theauto-immune/inflammatory diseases and oncology therapeutic areas which haveshown activity against clinically validated targets. 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