開拓藥業(09939.HK)在美國完成普克魯胺II期臨牀試驗患者入組
格隆匯 7 月 19日丨開拓藥業-B(09939.HK)發佈公告,截至2020年7月16日,集團已在美國完成II期臨牀試驗方案規定的患者招募工作。普克魯胺美國I期臨牀試驗於2019年5月完成。結果顯示普克魯胺對恩扎盧胺和阿比特龍等現有藥物治療後進展的轉移性去勢抵抗性前列腺癌(“mCRPC”)患者有良好的耐受性和一定的抗腫瘤療效。集團針對恩扎盧胺或阿比特龍治療失敗的mCRPC患者在美國十家中心開展多中心、開放標籤的隨機II期臨牀研究,旨在進一步評估普克魯胺的安全性及耐受性並確定後續臨牀試驗的劑量選擇。首名mCRPC於2019年6月開始給藥。患者(均在禁食狀態下)隨機分配至兩個治療組,每天分別服用400毫克及500毫克普克魯胺,每個治療組30名患者。
在美國進行的普克魯胺II期臨牀試驗進展順利,並未因目前的美國COVID-19疫情而受到重大影響。集團的目標是在2020年底前為使用阿比特龍或恩扎盧胺治療失敗的mCRPC患者完成正在進行的普克魯胺II期臨牀試驗。
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