Hutchmed Regulatory News (HCM)

8 Jan 2009 07:00



Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)

HMPL-002 Clinical Update

London: Thursday, 8 January 2009: Chi-Med, the pharmaceutical and healthcare group, today announces the HMPL-002 interim clinical result of its wholly-owned Shanghai-based drug R&D subsidiary, Hutchison MediPharma Limited ("HMPL"), for the Phase II proof-of-concept ("POC") study for HMPL-002 in China in patients with stage III non-small cell lung cancer ("NSCLC").

HMPL-002, a sensitizer used concomitantly in chemo-radiotherapy for treating cancer, has been in Phase I clinical testing in the United States in patients with locally advanced head and neck cancer and a Phase II POC study in China in patients with stage III NSCLC. HMPL-002 had completed its patient treatment phase of the clinical study in China earlier in 2008 and is now generating key trial data for a preliminary outcomes analysis.  The study in China of the drug candidate is entitled "an open label, multicenter, randomized, parallel controlled study to compare the efficacy and safety profile of chemo-radiotherapy with concomitant HMPL-002 use compared to standard chemo-radiotherapy for patients with inoperable stage IIIA/B non-small cell lung cancer". 

Based on the data collected and analysed to date, it has been found that the endpoint in tumour objective response (Complete Response plus Partial Response) in the locally advanced NSCLC population (Intent to Treat patients: 88) was 73.2% (30/41) in the HMPL-002 group versus 70.2% (33/47) in the control group. It is clear that the initial analysis of the study results showed no conclusive advantage in "tumour response" with oral use of HMPL-002 in the chemo-radiotherapy. In the study, HMPL-002 was found to be safe, and well tolerated with the most common adverse events being gastrointestinal.  The progression free survival, median survival time for 1 and 3 years, and time to progression are not available yet as the one year follow-up of full patients is scheduled to complete by Q1 2009.

Following this interim clinical result it has been decided to put clinical development of HMPL-002 on hold. A review of this decision will be made when both 1 and 3-year median survival data are available. This decision will enable HMPL to focus resources on advancing global trials on our lead clinical candidate, HMPL-004, in Crohn's disease and Ulcerative Colitis; preclinical development of multiple new single chemical entities; and our oncology and inflammation/immunology drug discovery and development collaborations with several global partners. 

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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. 

HMPL is Chi-Med's wholly-owned drug R&D subsidiary and has at its disposal 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. HMPL 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.