徐诺药业淋巴瘤1/2期临床试验完成首例患者给药
06/14/2019 Uncategorized admin
2019年6月6日  12:30 ET | 来源: Xynomic Pharmaceuticals Holdings, Inc.

美国北卡罗利市和中国上海市,

2019年6月6日/(GLOBE NEWSWIRE)

致力于抗肿瘤新药开发的中美跨国制药公司徐诺药业(纳斯达克:XYN)今日宣布,其候选药物艾贝司他与伊布替尼联用治疗复发/难治性套细胞淋巴瘤(“r / r MCL”)或复发/难治性弥漫性大B细胞淋巴瘤(“r / r DLBCL”)的1/2期临床试验在美国纪念斯隆-凯特琳癌症中心(MSK)完成首例患者给药。此项试验将招募约40名患者以评估上述药物组合在复发/难治性套细胞淋巴瘤(r / r MCL)或复发/难治性弥漫性大B细胞淋巴瘤(r / r DLBCL)患者中的安全性和有效性。此项试验还将探索对B细胞受体(BCR)和组蛋白去乙酰化酶(HDAC)双重抑制产生响应和耐药的生物学预测因子。此项在纪念斯隆-凯特琳癌症中心开展的临床试验,由杨森(Janssen Biotech, Inc.) 提供试验药品伊布替尼,徐诺药业提供试验药品艾贝司他和资金支持。

根据DR / Decision Resources,LLC的数据,套细胞淋巴瘤(MCL)在G7国家的年发病人数约为6,500人。 美国食品和药物管理局(FDA)已经批准伊布替尼用于治疗复发性套细胞淋巴瘤(MCL),其有效率为60-70%,中位持续缓解时间为18个月。艾贝司他单药治疗复发/难治性套细胞淋巴瘤(r / r MCL)患者的有效率为15.4%(7.7%完全缓解和7.7%部分缓解)。 纪念斯隆-凯特琳癌症中心的研究人员正在测试艾贝司他 / 伊布替尼联用是否能改善r / r MCL患者的有效率和持续缓解时间,并将在试验结束后进行评估。

根据白血病和淋巴瘤协会(LLS)的数据,弥漫性大B细胞淋巴瘤(DLBCL)是最常见的侵袭性非霍奇金淋巴瘤(NHL)亚型。 纪念斯隆-凯特琳癌症中心的研究人员在临床前研究中发现伊布替尼与HDAC抑制剂分别针对BCR通路上布鲁顿酪氨酸激酶(BTK)和MyD88-激发NF-kB活化的双重靶向抑制,在体外和体内均对MyD88突变、ABC-亚型DLBCL产生了协同的抗肿瘤活性。

艾贝司他是一款新型组蛋白去乙酰化酶抑制剂(HDAC),正在开展治疗非霍奇金淋巴瘤(NHL)和肾细胞癌全球关键性临床试验。 伊布替尼(IMBRUVICA®)是杨森,艾伯维和Pharmacyclics LLC联合开发首创BTK抑制剂,已批准用于多种血液系统恶性肿瘤和慢性移植物抗宿主病(cGVHD)。

 

关于徐诺药业

徐诺药业是一家专注于肿瘤药物开发的生物制药公司。徐诺药业目前的产品管线主要包括三款候选药物。公司拥有这些药物的全球独家开发、生产和商业化权益。其领先的候选药物艾贝司他正在进行治疗肾细胞癌(与培唑帕尼联用)和单药治疗非霍奇金淋巴瘤的全球关键临床试验。徐诺药业另外一款临床阶段候选药物为可进入临床2期的XP-105(BI 860585),这是一个ATP竞争性的mTORC1 / 2抑制剂,对多种实体瘤有效。徐诺药业的临床前候选药物XP-102(BI 882370)是一个治疗结肠直肠癌和黑色素瘤的泛-RAF抑制剂。

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