李氏大藥廠(00950.HK)合作公司Dilafor已完成Tafoxiparin的2b期研究
格隆匯6月2日丨李氏大藥廠(00950.HK)公佈,有關公司與Dilafor AB("Dilafor")(一間瑞典藥物開發公司,專注開發適應於產科的Tafoxiparin)於2014年2月訂立的特許協議,以在中國大陸、香港、澳門及台灣生產、開發及銷售適應於產科及婦科的Tafoxiparin。
於2021年6月1日,Dilafor已經完成了Tafoxiparin的2b期研究,該研究顯示Tafoxiparin對接受引產治療的初產婦宮頸成熟度有明顯的積極影響。這是一項雙盲、安慰劑對照2b期研究,研究對象為候選藥物Tafoxiparin,包括170名在瑞典及芬蘭診所登記的宮頸未成熟初產婦,彼等接受了宮頸成熟治療,從而促進分娩的開始。參與研究的患者在計劃引產前一週內每日接受一次Tafoxiparin或安慰劑的皮下注射。該研究的主要目的是記錄Tafoxiparin對宮頸成熟度的影響,宮頸成熟度乃根據國際公認的量表Bishop評分衡量。
研究結果顯示,與安慰劑相比,Tafoxiparin對子宮頸成熟度有積極作用,這一差異具有高度統計學意義(p<0.009)。基於該等積極的研究結果,Dilafor計劃延長2b期研究,以記錄Tafoxiparin在兩個較低劑量下的效果。
據悉,Tafoxiparin是由Dilafor開發的一種多醣專利藥物。經歷漫長而複雜的分娩過程的婦女缺乏一種在分娩中發揮重要作用的天然黏膜下層分子。臨牀前及臨牀數據顯示,Tafoxiparin可發揮該種分子的作用,可與對分娩極為重要的天然產生分子結合使用。
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