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FDA go-ahead allows Chi-Med oncology clinical trials expansi


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FDA go-ahead allows Chi-Med oncology clinical trials expansion

By Wai Lang Chu

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05/07/2006 - Chi-Med has been given the Food and Drug Administraton (FDA) green light to broaden its oncology drug candidate clinical trials after it exhibited encouraging results, which the company want to expand into a much wider patient population to fully assess its effects.

It's 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 (HNC) 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.

The FDA has given Chi-Med permission to amend its HMPL-002 Investigational New Drug (IND) and work will begin to prepare for a broadening of its US phase I/II clinical trials on 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.

“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,” said Christian Hogg, CEO of Chi-Med.

There is still a major unmet medical need for further improvements in the current treatment. 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.

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.

“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,” said Dr Trotti, a HNC radiation oncologist from the H. Lee Moffitt Cancer Center in Tampa.

“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 per cent). 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.

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