FDA FAST TRACK DESIGNATION FOR NARMAFOTINIB IN ADVANCED PANCREATIC CANCER
FDA FAST TRACK DESIGNATION FOR NARMAFOTINIB IN ADVANCED PANCREATIC CANCER
The Company's CEO and Managing Director, Dr HIGHLIGHTS
亮点
- The US FDA has granted Fast Track Designation to Amplia's lead drug narmafotinib in advanced pancreatic cancer
- Fast Track Designation facilitates the development of investigational drugs and allows for expedited review
- 美国FDA已授予爱文思控股旗下的主力药物narmafotinib在晚期胰腺癌领域的快速通道资格。
- 快速审批(FTD)有助于开发研究用药，并可以加快审查
MELBOURNE, Australia, Sept. 19, 2024 /PRNewswire/ -- Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to Amplia's Focal Adhesion Kinase inhibitor, narmafotinib, for the treatment of advanced pancreatic cancer.
澳大利亚墨尔本，2024年9月19日/美通社/ - Amplia Therapeutics Limited (ASX: ATX)（以下简称"Amplia"或"公司"）很高兴宣布美国食品和药物管理局(FDA)已将快速审批(FTD)授予Amplia的聚焦粘着激酶抑制剂narmafotinib，用于治疗晚期胰腺癌。
Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions. It is designed to speed the development of these drugs to enable patients to receive them sooner. This Designation will grant the Company access to more frequent meetings, and written communication, with the FDA. In future, narmafotinib may be eligible for Accelerated Approval and Priority Review. The Company has previously received Orphan Drug Designation from the FDA for narmafotinib in pancreatic cancer.
快速审批(FTD)适用于可能在治疗严重疾病方面具有优势的药物。它旨在加快这些药物的开发，使患者能够更早地接受治疗。这一认定将使公司获得与FDA更加频繁的会议和书面沟通的机会。未来，narmafotinib可能还有资格获得加速批准和优先审批。该公司之前已经获得了FDA授予narmafotinib用于胰腺癌治疗的孤儿药物认定。
The Company's CEO and Managing Director, Dr Chris Burns, commented, "Fast Track Designation for narmafotinib is a significant milestone for the Company. With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease."
公司的首席执行官兼总经理Chris Burns博士评论道：“narmafotinib的快速认定是公司的一个重要里程碑。凭借这一认定，我们可以与FDA更紧密地合作，加速我们的临床计划，并为该可怕的疾病获得最有力的审批证据。
Amplia's clinical trial in advanced pancreatic cancer, the ACCENT trial, is ongoing in Australia and South Korea. Earlier this year, the Company announced that the US FDA had cleared its IND[1] application for a trial of narmafotinib in pancreatic cancer in the US. This trial is in advanced planning stages.
Amplia在澳大利亚和韩国进行的晚期胰腺癌临床试验ACCENt正在进行中。今年早些时候，该公司宣布美国FDA已批准其在美国进行narmafotinib胰腺癌试验的IND[1]申请。该试验目前处于筹备阶段。
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
该ASX公告已获得并经Amplia Therapeutics董事会授权发布。
|
[1] Investigational New Drug |
|
[1] 新药研究 |
About Narmafotinib
关于Narmafotinib
Narmafotinib (AMP945) is the company's best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy.
Narmafotinib（AMP945）是该公司的最佳FAk蛋白抑制剂，一种在胰腺和其他癌症中过度表达的蛋白质，也是固体肿瘤领域引起越来越多关注的药物靶点。这种药物是FAk的高效选择性抑制剂，在一系列临床前癌症研究中显示出有希望的数据。该药物已经成功完成了健康志愿者研究，并目前正在胰腺癌的开放标签2a期评估narmafotinib与化疗药物吉西他滨和Abraxane的安全性，耐受性和疗效。
About Amplia Therapeutics Limited
关于Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit and follow Amplia on Twitter (@ampliatx), Threads (@ampliatx) and LinkedIn.
Amplia Therapeutics Limited是一家澳大利亚制药公司，致力于开发用于癌症和纤维化的脉络蛋白激酶（FAK）抑制剂。FAk在癌症领域越来越重要，Amplia在纤维癌症（如胰腺癌和卵巢癌）的开发上有着特殊的发展重点。FAk在多种慢性疾病（如特发性肺纤维化）中也发挥着重要作用。更多信息请访问并关注Amplia的Twitter（@ampliatx）、Threads（@ampliatx）和LinkedIn。
SOURCE Amplia Therapeutics Ltd
资料来源：Amplia Therapeutics Ltd
