EN
登录

Candel获得美国食品药品监督管理局CAN-2409 Plus前药快速通道指定

Candel Receives FDA Fast Track Designation For CAN-2409 Plus Prodrug

RTTNews 等信源发布 2023-12-12 21:57

可切换为仅中文


Candel Therapeutics, Inc. (CADL) on Tuesday announced that it has received Fast Track Designation from the FDA for their lead investigational asset called CAN-2409 plus prodrug (valacyclovir).This asset is being developed to improve overall survival in patients with pancreatic ductal adenocarcinoma (PDAC).Candel's CEO, Paul Peter Tak, MD, PhD, FMedSci, stated that this news comes following an interim data report regarding the phase 2 clinical trial of CAN-2409 involving patients with borderline resectable PDAC which has shown promising results so far.

Candel Therapeutics,Inc.(CADL)周二宣布,它已获得FDA的快速通道指定,用于其主要研究资产CAN-2409 plus前药(伐昔洛韦)。正在开发该资产以提高胰腺导管腺癌(PDAC)患者的总体生存率。Candel的首席执行官Paul Peter Tak,医学博士,FMedSci博士表示,这一消息是在关于CAN-2409的2期临床试验的中期数据报告之后发布的,该试验涉及临界可切除PDAC患者,迄今为止已显示出有希望的结果。

.

.

The data revealed that CAN-2409 extended and maintained patient survival, particularly when compared with real-world radiotherapy data, with an estimated 71.4% survival at 24 and 36 months for patients receiving 2 or 3 injections of the CAN-2409 plus prodrug regimen, together with SoC chemoradiation before surgery.CADL is trading up by 68.37% at $0.57 per share in the pre-market trade on the Nasdaq.

数据显示,CAN-2409延长并维持了患者的生存期,特别是与现实世界的放疗数据相比,接受2或3次注射CAN-2409加前药方案的患者在24个月和36个月时的生存率估计为71.4%,以及手术前的SoC放化疗。在纳斯达克上市前交易中,CADL股价上涨68.37%,至每股0.57美元。

For comments and feedback contact: editorial@rttnews.comBusiness News.

如需评论和反馈,请联系:editorial@rttnews.combusiness新闻。

Biotech Stocks Facing FDA Decision In November 2023

2023年11月美国食品和药物管理局(FDA)决定生物技术股

Biotech Stocks Facing FDA Decision In October 2023

2023年10月美国食品和药物管理局(FDA)决定生物技术股

Biotech Stocks Facing FDA Decision in August 2023

2023年8月美国食品和药物管理局(FDA)决定生物技术股