Chi-Med gets FDA OK to amend protocol

By Elaine Rigoli

Tampa, Fla., July 5 - Hutchison China Meditech Ltd. (Chi-Med) said it has received permission from the Food and Drug Administration to amend its HMPL-002 Investigational New Drug clinical protocol from patients receiving radiation therapy alone to now include the much larger patient population undergoing concurrent platinum-based chemoradiotherapy.

"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," chief executive officer Christian Hogg said in a news release.

HMPL-002 is a botanical extract intended for use as an orally administered radio-sensitizer and is under development for the treatment of head and neck cancer and non-small cell lung cancer in patients undergoing radiotherapy.

Hong Kong-based Chi-Med, the holding company of a pharmaceutical and health care group, is a subsidiary of Hutchison Whampoa Ltd.

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