徐诺药业获得重要的中国癌症医院伦理委员会认证
08/14/2019 新闻 admin

美国北卡罗利市和中国上海市 2019年8月7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(股票代码:XYNO)今日宣布中国福建省立医院,华中科技大学同济医学院附属同济医院,山东大学齐鲁医院的伦理委员会已经批准徐诺药业其候选药物艾贝司他与培唑帕尼联用治疗肾细胞癌(RCC)的潜在关键性3期临床试验的伦理申请。

北京肿瘤医院的副所长,肾癌&黑色素瘤内科主任郭军教授是此临床试验的主要研究者。据复旦大学医院管理研究所数据,北京肿瘤医院是中国排名前三的癌症专科医院。

“高效的研究机构对临床试验成功至关重要。徐诺药业在开始新临床试验时的一项关键决定便是选择主要研究者。我们很高兴与这些具备世界级基础设施的研究机构合作并完成方案规定的试验。此外,这些研究机构日常接诊大量的淋巴瘤患者,这非常有利于患者招募。”徐诺药业董事长兼首席执行官徐英霖先生评论说。

此外,中国医学科学院肿瘤医院的伦理委员会已经批准徐诺药业下述两项潜在关键性2期临床试验的伦理申请:1)艾贝司他单药三线治疗弥漫大B细胞淋巴瘤(DLBCL)的临床试验,2)艾贝司他单药三线治疗滤泡性淋巴瘤(FL)的临床试验。根据中华医学会血液学会的数据,弥漫大B细胞淋巴瘤和滤泡性淋巴瘤是中国最常见和第二常见的非霍奇金淋巴瘤亚型。

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,艾贝司它、 XP-105 和 XP-102。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)是一个泛-RAF抑制剂。
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