-- 根據週二提交給澳洲證券交易所的文件顯示,Starpharma Holdings(ASX:SPL)已收到美國食品藥物管理局(FDA)對其DEP HER2放射療法候選藥物首次人體I期臨床試驗方案的正面回饋。 該公司正在開發該候選藥物,用於治療某些胃癌/胃食道交界處癌以及其他先前接受過標靶治療的晚期癌症患者。 美國FDA的回饋支持啟動I期臨床試驗的計劃,該試驗預計將於今年下半年開始。 Starpharma表示,FDA也確認該放射療法候選藥物針對的族群有顯著的未滿足醫療需求,這表明該藥物有可能獲得快速通道資格或其他加速開發途徑。 該公司股價在周二的交易中上漲了7%。
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