The US Food and Drug Administration has given Chi-Med, a holding company for a drug and health care group based primarily in China, permission 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 chemo-radiotherapy.
As a result, Chi-Med says it will begin to prepare for a broadening of its US Phase I/II clinical trials on its leading oncology drug candidate (HMPL-002). The company plans to expand studies of the compound to a patient population undergoing concurrent radiation therapy and platinum-based chemo-radiotherapy.
Christian Hogg, chief executive 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."
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