Hutchison China Meditech Limited
04 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-002
Investigational New Drug (IND) clinical protocol from patients receiving
radiation therapy alone to now include the much larger patient population
undergoing concurrent platinum-based chemoradiotherapy.
Chi-Med today announces that, following the FDA's recent permission to amend its
HMPL-002 IND, work will begin to prepare for a broadening of its US phase I/II
clinical trials on its leading oncology drug candidate (HMPL-002). Chi-Med
plans to expand HMPL-002 trials to a patient population undergoing concurrent
radiation therapy and platinum-based chemoradiotherapy, rather than as up to now
only among the much smaller patient population receiving radiation therapy
alone.
Christian Hogg, CEO of Chi-Med, said:
'This is good news. Widening the universe among which we can conduct clinical
trials will make it easier and speedier to recruit trial patients. More
fundamentally, it broadens the future market potential for this important drug
candidate.'
HMPL-002 is a botanical extract intended for use as an orally administered
radiosensitiser and is under development for the treatment of head and neck
cancer and non-small cell lung cancer in patients undergoing radiotherapy.
Current US Phase I/II clinical trials of HMPL-002 are as a radiosensitiser
administered in locally advanced HNC cancer patients receiving radiation therapy
alone.
Chi-Med has been actively looking to broaden the potential market for HMPL-002
by pursuing the development for concomitant use with platinum-based
chemoradiotherapy that is now considered the standard treatment for most locally
advanced HNC patients.
Dr. A. Trotti, a leading HNC radiation oncologist from the H. Lee Moffitt Cancer
Center in Tampa said:
'Radiation therapy, used as a single modality, is no longer the sole treatment
choice for locally advanced HNC patients who are not suitable for surgical
resection; platinum-based regimens concurrently administered with conventional
radiation have become a preferred standard for many patients in recent years.
There is, however, still a need to improve outcomes in patients with locally
advanced HNC (the 3-year survival estimate for Cisplatin concurrent with
radiation is only about 40%). Integrating new radiation sensitisers into
concurrent combined-modality programs is an active area of investigation for
this patient group.'
HMPL-002 achieves its radiosensitising effect by reducing hypoxic conditions
within the tumour cells, thus increasing the tumour's response to radiation.
This biological effect is mediated by inhibition of multiple cellular metabolic
pathways in tumour cells such as the regulation of oxygen homeostasis.
HMPL-002 is already a marketed radiosensitiser in China and indicated for
concurrent use with radiotherapy to treat lung, esophageal and head and neck
cancer. Multiple trials from phase I-III were conducted in China from 1993-1998
on over 3,000 human subjects, which demonstrated the treatment's efficacy and
safety in the Chinese population and were the basis for its final market
approval 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 in
a much larger patient population where there is a clear unmet need.'
Squamous cell carcinoma of the head and neck is a major public health problem
with approximately 40,000 new cases of head and neck cancer occurring in the US
in 2005. Improving the outcome for patients with locally advanced head and neck
carcinomas by rational modification of radiation fractionation regimens or
combinations of radiation with chemotherapy has been the subject of intensive
clinical investigation for more than three decades. There is still a major
unmet medical need for further improvements in the current treatment. Although
the conventional or hyperfractionated radiation therapy is applied to almost all
locally advanced HNC patients, the local-regional control rate and long-term
survival benefit still remain unsatisfactory to the medical community.
Ends
Enquiries
Chi-Med Telephone: +852-2121-8200
Christian Hogg, CEO
www.Chi-Med.com
Citigate Dewe Rogerson Telephone: +44 (0)20 7638 9571
Anthony 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 based
primarily in China and is listed on the Alternative Investment Market of the
London Stock Exchange.
Chi-Med conducts pharmaceutical research and development of botanical drugs,
semi-synthetic natural product drugs, and synthetic single chemical entity drugs
through its wholly owned Hutchison MediPharma subsidiary. Hutchison MediPharma
aims to bring novel drugs to the global market for the treatment of cancer and
auto-immune diseases by using modern drug discovery and development technologies
and clinical standards that meet the requirements of ICH guidelines.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international
corporation 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
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