德琪醫藥-B(06996.HK):國家藥監局批准ELTANEXOR治療晚期實體瘤IB/II期臨試IND申請
格隆匯5月14日丨德琪醫藥-B(06996.HK)發佈公吿,2021年5月14日,中國國家藥品監督管理局(NMPA)已批准eltanexor(ATG-016)開展一項Ib/II期開放性、多中心、劑量探索的臨牀試驗(REACH),用於治療晚期實體瘤患者。
該試驗旨在評估eltanexor單藥治療晚期實體瘤患者的安全性及有效性。其中,Ib期試驗受試者將包括KRAS突變、p53野生型、人類免疫缺陷病毒(HPV)相關、愛潑斯坦-巴爾病毒(EBV)陽性和其他晚期實體瘤患者,而II期試驗受試者將包括復發或轉移性陰莖鱗狀細胞癌患者及復發或轉移性鼻咽癌患者。
Eltanexor是新一代選擇性核輸出抑制劑(SINE)化合物,通過抑制核輸出蛋白XPO1導致腫瘤抑制蛋白的核內滯留及活化,同時阻斷致癌蛋白的表達和轉移,從而抑制腫瘤細胞生長與增殖。在癌症患者中,XPO1水平升高通常與預後差和化療耐藥性相關。臨牀前數據表明,eltanexor在廣泛的腫瘤細胞中顯示出強大的促凋亡活性,而正常細胞不受影響。此外,在多個實體瘤(例如肝細胞癌、前列腺癌、胰腺癌、結腸癌、乳腺癌等)動物模型中,eltanexor也體現出良好的抗腫瘤活性。
德琪醫藥創始人、董事長兼首席執行官梅建明博士表示:“此次臨牀試驗獲批,標誌着德琪醫藥在eltanexor的臨牀研發上邁出了重要的一步,我們相信實體瘤患者將會從這個創新且有效的作用機制中獲益。依託良好的臨牀前與臨牀數據,eltanexor單藥治療有望改善國內晚期實體瘤患者的治療現狀,並提高他們的生活質量。”
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