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Starpharma公司称美国FDA支持其癌症放射疗法候选药物的首次人体试验;股价上涨7%。

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-- 据周二提交给澳大利亚证券交易所的文件显示,Starpharma Holdings(ASX:SPL)已收到美国食品药品监督管理局(FDA)对其DEP HER2放射疗法候选药物首次人体I期临床试验方案的积极反馈。 该公司正在开发该候选药物,用于治疗某些胃癌/胃食管交界处癌以及其他既往接受过靶向治疗的晚期癌症患者。 美国FDA的反馈支持启动I期临床试验的计划,该试验预计将于今年下半年开始。 Starpharma表示,FDA还确认该放射疗法候选药物针对的人群存在显著的未满足医疗需求,这表明该药物有可能获得快速通道资格或其他加速开发途径。 该公司股价在周二的交易中上涨了7%。

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