JERUSALEM, April 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT

耶路撒冷，2025年4月2日（环球新闻社）-- Alpha Tau Medical Ltd.（纳斯达克股票代码：DRTS，DRTSW），创新的阿尔法辐射癌症治疗Alpha DaRT的开发者

, announced today that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with recurrent glioblastoma (GBM) using the Alpha DaRT technology.

今天宣布，美国食品药品监督管理局（FDA）已批准了一项研究性器械豁免（IDE）申请，以启动使用Alpha DaRT技术治疗复发性胶质母细胞瘤（GBM）患者的试点研究。

“This is very exciting news for patients suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial, we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are not amenable to surgery,” said Dr.

“这对患有胶质母细胞瘤的患者来说是非常令人兴奋的消息，胶质母细胞瘤是一种高度侵袭性的脑癌，预后和生存率极差。在这项试验中，我们将引入一种全新的方法，专门设计用于将Alpha DaRT源递送到无法手术的脑肿瘤中，”博士表示。

Robert B. Den, Alpha Tau Chief Medical Officer. “According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months.”.

罗伯特·B·邓，Alpha Tau首席医疗官。“根据国家脑肿瘤协会的数据，胶质母细胞瘤是最复杂、最致命且治疗抵抗性最强的癌症之一，估计平均生存期仅为8个月。”

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment following the Company’s promising results from pre-clinical studies..

预计临床试验将招募多达十名美国复发性胶质母细胞瘤患者，这些患者不适合手术切除，并且曾经接受过中枢神经系统放射治疗。该研究的主要目的是在公司临床前研究取得可喜结果后，评估该治疗的可行性和安全性。

“This IDE approval follows the FDA’s continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received the FDA’s Breakthrough Device Designation, followed by acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program to accelerate the Alpha DaRT treatment to market and to the GBM patients who may stand to benefit greatly,” added Alpha Tau Chief Executive Officer Uzi Sofer..

“这一IDE批准紧随FDA持续认可这项技术对复发性胶质母细胞瘤患者所具有的巨大潜力之后；此前该技术已获得FDA的突破性设备认定，并被纳入FDA备受推崇的全产品生命周期咨询计划，以加速Alpha DaRT治疗进入市场，惠及可能从中极大受益的GBM患者，”Alpha Tau首席执行官乌齐·索弗补充道。

About Alpha DaRT

关于 Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor.

Alpha DaRT（扩散型α发射体放射治疗）旨在通过向肿瘤内递送浸润了镭-224的源来实现对实体瘤进行高效且适形的α照射。当镭衰变时，其短寿命子体从源中释放并扩散，同时发射高能α粒子，以达到摧毁肿瘤的目的。

Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it..

由于发射α粒子的原子只扩散很短的距离，Alpha DaRT 的目的是主要影响肿瘤，并且避免损伤其周围的健康组织。

About Alpha Tau Medical Ltd.

关于阿尔法陶医疗有限公司。

Founded in 2016, Alpha Tau Medical Ltd. ('Alpha Tau', or the “Company”) is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT® for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof.

成立于2016年的Alpha Tau Medical Ltd.（“Alpha Tau”或“公司”）是一家以色列肿瘤治疗公司，专注于研究、开发和潜在商业化Alpha DaRT®技术，用于治疗实体瘤。该技术最初由伊扎克·凯尔森教授和另一位教授开发。