公司陈述
所有Magrolimab研究重新开放了美国的患者入学率
加利福尼亚州福斯特市,2022年6月3日- 爱游戏足彩 Gilead Sciences,Inc。(NASDAQ:GILD)今天宣布,美国食品和药物管理局(FDA)取消了评估Magrolimab作为淋巴瘤和多发性骨髓瘤(MM)的潜在治疗的研究的剩余部分临床持有。tFDA的决定是对Magrolimab淋巴瘤研究的安全数据进行了全面审查。没有进一步修改我们的安全语言,删除了该持有,也没有确定新的安全信号。
正如先前宣布的那样,FDA于4月11日举起了骨髓增生综合征(MDS)和急性髓细胞性白血病(AML)的研究研究研究Magrolimab的部分临床研究。恢复E U.S. Gilead正在重新激活全球所有研究,并已获得批准,以重新启动在法国,德国和英国等多个国家的患者入学。第三阶段的增强研究MDS在部分临床保留之前达到了预先指定的入学阈值,该研究在1H23的第一次临时读数仍处于正轨状态。
“血液学癌症通常与预后不良有关,迫切需要更好的治疗选择,”吉利德科学首席医学官Merdad Parsey博士说。爱游戏足彩“吉利德(Gilead)仍然专注于马格洛利莫(Magrolimab)计划,并有可能影响未满足需求的患者。我们感谢FDA及时提升部分临床保留,使我们能够在我们努力推进研究性CD47抗体疗法的过程中尽快重新激活试验的入学率。”
有关淋巴瘤的更多信息(NCT02953509)和毫米((NCT04892446)学习可以在www.clinicaltrials.gov。
Magrolimab是研究产品,未经任何监管机构批准任何用途;它的安全性和功效尚未确定。
关于Magrolimab
Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including MDS, AML as well as solid tumor malignancies. More information about clinical trials with magrolimab is available atwww.clinicaltrials.gov。
关于吉利德科爱游戏足彩学
爱游戏足彩Gilead Sciences,Inc。是一家生物制药公司,在三十年中一直在医学领域取得突破,目的是为所有人创造一个更健康的世界。该公司致力于推进创新的药物,以预防和治疗威胁生命的疾病,包括艾滋病毒,病毒肝炎和癌症。吉利德(Gilead)在全球35个国家 /地区开展业务,总部位于加利福尼亚州福斯特市。
前瞻性语句
this press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving magrolimab; uncertainties relating to regulatory applications and related filing and approval timelines, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use, including those involving magrolimab; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
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