-- BriaCell Therapeutics(BCT.TO)週三宣布,其下一代細胞免疫療法Bria-BRES+已獲得美國食品藥物管理局(FDA)批准,可啟動針對轉移性乳癌的臨床評估。 該公司致力於開發新型免疫療法,並表示FDA批准其研究性新藥(IND)申請,標誌著Bria-BRES+的1/2a期臨床研究正式啟動。 Bria-BRES+添加了額外的免疫活化成分,旨在提升臨床療效。 Bria-BRES+基於Bria-OTS乳癌臨床項目,該項目首例接受Bria-BRES+治療的患者實現了肺轉移灶的持續完全消退。聲明指出,該患者接受了17次療程的Bria-OTS治療,完成了12個月的研究,目前仍在接受存活追蹤。 「我們很榮幸地宣布,FDA批准了我們下一代個人化免疫療法Bria-BRES+的首個IND申請,」執行長William Williams表示。 「Bria-BRES+ 的獨特設計使其在轉移性乳癌治療中展現出良好的安全性和顯著的療效。我們期待推進 Bria-BRES+ 的臨床試驗,為這些幾乎沒有有效治療選擇的患者帶來新的希望。” BriaCell 股票在紐約交易中最新報下跌 0.02 美元,至 4.05 美元。
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