Hutchmed Regulatory News (HCM)

4 Jul 2006 07:00

Hutchison China Meditech Limited04 July 2006 4 July 2006 Hutchison China Meditech Limited ("Chi-Med") (AIM: HCM) Chi-Med plans to broaden clinical trials of its leading oncology drug candidate • US FDA gives Chi-Med permission to amend its HMPL-002Investigational New Drug (IND) clinical protocol from patients receivingradiation therapy alone to now include the much larger patient populationundergoing concurrent platinum-based chemoradiotherapy. Chi-Med today announces that, following the FDA's recent permission to amend itsHMPL-002 IND, work will begin to prepare for a broadening of its US phase I/IIclinical trials on its leading oncology drug candidate (HMPL-002). Chi-Medplans to expand HMPL-002 trials to a patient population undergoing concurrentradiation therapy and platinum-based chemoradiotherapy, rather than as up to nowonly among the much smaller patient population receiving radiation therapyalone. Christian Hogg, CEO of Chi-Med, said: "This is good news. Widening the universe among which we can conduct clinicaltrials will make it easier and speedier to recruit trial patients. Morefundamentally, it broadens the future market potential for this important drugcandidate." HMPL-002 is a botanical extract intended for use as an orally administeredradiosensitiser and is under development for the treatment of head and neckcancer and non-small cell lung cancer in patients undergoing radiotherapy.Current US Phase I/II clinical trials of HMPL-002 are as a radiosensitiseradministered in locally advanced HNC cancer patients receiving radiation therapyalone. Chi-Med has been actively looking to broaden the potential market for HMPL-002by pursuing the development for concomitant use with platinum-basedchemoradiotherapy that is now considered the standard treatment for most locallyadvanced HNC patients. Dr. A. Trotti, a leading HNC radiation oncologist from the H. Lee Moffitt CancerCenter in Tampa said: "Radiation therapy, used as a single modality, is no longer the sole treatmentchoice for locally advanced HNC patients who are not suitable for surgicalresection; platinum-based regimens concurrently administered with conventionalradiation have become a preferred standard for many patients in recent years.There is, however, still a need to improve outcomes in patients with locallyadvanced HNC (the 3-year survival estimate for Cisplatin concurrent withradiation is only about 40%). Integrating new radiation sensitisers intoconcurrent combined-modality programs is an active area of investigation forthis patient group." HMPL-002 achieves its radiosensitising effect by reducing hypoxic conditionswithin the tumour cells, thus increasing the tumour's response to radiation.This biological effect is mediated by inhibition of multiple cellular metabolicpathways in tumour cells such as the regulation of oxygen homeostasis. HMPL-002 is already a marketed radiosensitiser in China and indicated forconcurrent use with radiotherapy to treat lung, esophageal and head and neckcancer. Multiple trials from phase I-III were conducted in China from 1993-1998on over 3,000 human subjects, which demonstrated the treatment's efficacy andsafety in the Chinese population and were the basis for its final marketapproval in China by the State Food and Drug Administration in 1998. Dr. Samantha Du, Chi-Med's Chief Scientific Officer said: "We are excited about the FDA's permission to amend our HMPL-002 IND protocol.This amendment allows us to further investigate this promising drug candidate ina much larger patient population where there is a clear unmet need." Squamous cell carcinoma of the head and neck is a major public health problemwith approximately 40,000 new cases of head and neck cancer occurring in the USin 2005. Improving the outcome for patients with locally advanced head and neckcarcinomas by rational modification of radiation fractionation regimens orcombinations of radiation with chemotherapy has been the subject of intensiveclinical investigation for more than three decades. There is still a majorunmet medical need for further improvements in the current treatment. Althoughthe conventional or hyperfractionated radiation therapy is applied to almost alllocally advanced HNC patients, the local-regional control rate and long-termsurvival benefit still remain unsatisfactory to the medical community. Ends Enquiries Chi-Med Telephone: +852-2121-8200Christian Hogg, CEOwww.Chi-Med.com Citigate Dewe Rogerson Telephone: +44 (0)20 7638 9571Anthony Carlisle (Mobile: 07973 611 888)Chris Gardner (Mobile: 07903 737 649) About Chi-Med Chi-Med is the holding company of a pharmaceutical and healthcare group basedprimarily in China and is listed on the Alternative Investment Market of theLondon Stock Exchange. Chi-Med conducts pharmaceutical research and development of botanical drugs,semi-synthetic natural product drugs, and synthetic single chemical entity drugsthrough its wholly owned Hutchison MediPharma subsidiary. Hutchison MediPharmaaims to bring novel drugs to the global market for the treatment of cancer andauto-immune diseases by using modern drug discovery and development technologiesand clinical standards that meet the requirements of ICH guidelines. Chi-Med is majority owned by Hutchison Whampoa Limited, an internationalcorporation listed on the Main Board of the Hong Kong Stock Exchange. This information is provided by RNS The company news service from the London Stock Exchange