Alpha Tau Receives FDA Approval to Initiate a Trial for Patients with Recurrent Glioblastoma
Alpha Tau Medical (NASDAQ: DRTS) has received FDA approval for an Investigational Device Exemption (IDE) to begin a pilot study treating recurrent glioblastoma (GBM) patients with their Alpha DaRT® technology. The trial will enroll up to 10 U.S. patients with recurrent GBM who are not candidates for surgery and have previously undergone central nervous system radiation.
The study's primary goal is to assess the feasibility and safety of the treatment, building on promising pre-clinical results. This approval follows the FDA's earlier Breakthrough Device Designation and acceptance into the FDA's Total Product Life Cycle Advisory Program, aimed at accelerating the Alpha DaRT treatment's path to market.
Glioblastoma is described as one of the most complex and treatment-resistant cancers, with an average survival rate of only 8 months, according to the National Brain Tumor Society.
Alpha Tau Medical (NASDAQ: DRTS) ha ricevuto l'approvazione della FDA per un'Esenzione per Dispositivo Investigativo (IDE) per avviare uno studio pilota nel trattamento di pazienti con glioblastoma ricorrente (GBM) utilizzando la loro tecnologia Alpha DaRT®. Lo studio arruolerà fino a 10 pazienti statunitensi con GBM ricorrente che non sono candidati per un intervento chirurgico e che hanno precedentemente subito radiazioni al sistema nervoso centrale.
Il principale obiettivo dello studio è valutare la fattibilità e la sicurezza del trattamento, basandosi su risultati preclinici promettenti. Questa approvazione segue la precedente Designazione di Dispositivo Innovativo della FDA e l'accettazione nel Programma di Consulenza sul Ciclo di Vita Totale del Prodotto della FDA, volto ad accelerare il percorso del trattamento Alpha DaRT verso il mercato.
Il glioblastoma è descritto come uno dei tumori più complessi e resistenti ai trattamenti, con una durata media di sopravvivenza di soli 8 mesi, secondo la National Brain Tumor Society.
Alpha Tau Medical (NASDAQ: DRTS) ha recibido la aprobación de la FDA para una Exención de Dispositivo Investigacional (IDE) para comenzar un estudio piloto tratando a pacientes con glioblastoma recurrente (GBM) con su tecnología Alpha DaRT®. El ensayo incluirá hasta 10 pacientes estadounidenses con GBM recurrente que no son candidatos para cirugía y que han recibido previamente radioterapia en el sistema nervioso central.
El objetivo principal del estudio es evaluar la viabilidad y la seguridad del tratamiento, basándose en resultados preclínicos prometedores. Esta aprobación sigue a la anterior Designación de Dispositivo Innovador de la FDA y la aceptación en el Programa de Asesoría del Ciclo de Vida Total del Producto de la FDA, destinado a acelerar el camino del tratamiento Alpha DaRT hacia el mercado.
El glioblastoma se describe como uno de los cánceres más complejos y resistentes al tratamiento, con una tasa de supervivencia promedio de solo 8 meses, según la National Brain Tumor Society.
알파 타우 메디컬 (NASDAQ: DRTS)는 재발성 교모세포종 (GBM) 환자를 대상으로 Alpha DaRT® 기술을 사용한 파일럿 연구를 시작하기 위해 FDA의 조사 기기 면제(IDE) 승인을 받았습니다. 이 시험은 수술 후보가 아니며 이전에 중추신경계 방사선 치료를 받은 재발성 GBM 환자 최대 10명을 등록할 예정입니다.
연구의 주요 목표는 치료의 실행 가능성과 안전성을 평가하는 것으로, 유망한 전임상 결과를 바탕으로 하고 있습니다. 이 승인은 FDA의 이전 혁신 기기 지정 및 Alpha DaRT 치료의 시장 진입 경로를 가속화하기 위한 FDA의 전체 제품 생애 주기 자문 프로그램에의 수용에 따른 것입니다.
교모세포종은 가장 복잡하고 치료 저항성이 강한 암 중 하나로 설명되며, National Brain Tumor Society에 따르면 평균 생존율은 단 8개월입니다.
Alpha Tau Medical (NASDAQ: DRTS) a reçu l'approbation de la FDA pour une Exemption de Dispositif Investigational (IDE) afin de commencer une étude pilote traitant des patients atteints de glioblastome récurrent (GBM) avec leur technologie Alpha DaRT®. L'essai inclura jusqu'à 10 patients américains atteints de GBM récurrent qui ne sont pas candidats à la chirurgie et qui ont déjà subi une radiothérapie du système nerveux central.
L'objectif principal de l'étude est d'évaluer la faisabilité et la sécurité du traitement, en s'appuyant sur des résultats précliniques prometteurs. Cette approbation fait suite à la précédente Désignation de Dispositif Innovant de la FDA et à l'acceptation dans le Programme de Conseil sur le Cycle de Vie Total du Produit de la FDA, visant à accélérer le chemin du traitement Alpha DaRT vers le marché.
Le glioblastome est décrit comme l'un des cancers les plus complexes et résistants aux traitements, avec un taux de survie moyen de seulement 8 mois, selon la National Brain Tumor Society.
Alpha Tau Medical (NASDAQ: DRTS) hat die FDA-Zulassung für eine Investigational Device Exemption (IDE) erhalten, um eine Pilotstudie zur Behandlung von Patienten mit wiederkehrendem Glioblastom (GBM) mit ihrer Alpha DaRT®-Technologie zu beginnen. Die Studie wird bis zu 10 Patienten aus den USA mit wiederkehrendem GBM einschließen, die nicht für eine Operation geeignet sind und zuvor eine Strahlentherapie des zentralen Nervensystems erhalten haben.
Das Hauptziel der Studie besteht darin, die Durchführbarkeit und Sicherheit der Behandlung zu bewerten, basierend auf vielversprechenden präklinischen Ergebnissen. Diese Genehmigung folgt der früheren Breakthrough Device Designation der FDA und der Aufnahme in das Total Product Life Cycle Advisory Program der FDA, das darauf abzielt, den Weg der Alpha DaRT-Behandlung auf den Markt zu beschleunigen.
Glioblastom wird als einer der komplexesten und behandlungsresistentesten Krebsarten beschrieben, mit einer durchschnittlichen Überlebensrate von nur 8 Monaten, laut der National Brain Tumor Society.
- FDA approval to initiate pilot study for recurrent glioblastoma treatment
- Previous FDA Breakthrough Device Designation obtained
- Acceptance into FDA's Total Product Life Cycle Advisory Program for accelerated market access
- initial trial size of only 10 patients
- Early-stage pilot study focused only on feasibility and safety, not efficacy
Insights
This FDA approval of Alpha Tau's Investigational Device Exemption (IDE) represents a significant regulatory milestone for their Alpha DaRT technology in treating recurrent glioblastoma (GBM). The IDE approval allows Alpha Tau to begin a pilot safety trial with up to ten patients who have this aggressive brain cancer and aren't candidates for surgical intervention.
Glioblastoma is among the most treatment-resistant cancers, with an average survival of only 8 months. Current standard-of-care typically involves a combination of surgery, radiation, and chemotherapy, but recurrence is common and treatment options become severely afterward. Alpha Tau's technology uses alpha radiation, which delivers higher energy over shorter distances compared to conventional radiation approaches, potentially offering better tumor control with less collateral damage to surrounding brain tissue.
This regulatory advancement builds upon prior FDA recognition through both Breakthrough Device Designation and inclusion in the agency's Total Product Life Cycle Advisory Program. These special designations indicate the FDA recognizes the significant unmet medical need and the potential of Alpha DaRT to address it, potentially streamlining the development pathway.
While this pilot study focuses primarily on safety and feasibility rather than efficacy, it represents the crucial first step in clinical validation of Alpha DaRT for brain tumors. The technology's novel approach to delivering alpha radiation directly into tumors could offer a meaningful alternative for patients currently facing extremely options.
Alpha Tau's IDE approval for GBM trials represents a strategic expansion of their Alpha DaRT technology into one of oncology's most challenging frontiers. The technology's mechanism - delivering alpha radiation sources directly into tumors - is particularly well-suited for brain applications where precision is paramount and collateral damage to healthy tissue must be minimized.
The regulatory pathway for neuro-oncology devices is notoriously challenging, making this IDE approval particularly meaningful. Alpha Tau's previous designation into the FDA's Total Product Life Cycle Advisory Program provides an accelerated regulatory framework that could significantly compress development timelines. This program is highly selective, indicating strong regulatory confidence in the technology's potential.
From a technical perspective, Alpha DaRT's application in brain tumors that are "not amenable to surgery" addresses a critical treatment gap. Recurrent GBM after radiation represents one of medicine's most difficult treatment scenarios, with few viable interventions. The ability to deliver localized alpha radiation could potentially overcome the blood-brain barrier challenges that limit drug delivery.
While the initial trial scope is modest with ten patients, focused on safety and feasibility endpoints, this represents the necessary foundation for potential registration trials. The treatment-resistant nature of GBM means that even incremental improvements in outcomes could represent significant clinical value. The technology's potential application in this indication could serve as a powerful proof-of-concept for Alpha DaRT's utility in treating complex, anatomically challenging solid tumors.
JERUSALEM, April 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, 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.
“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. 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.”
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.
“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.
About 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. 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.
About Alpha Tau Medical Ltd.
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. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
IR@alphatau.com
FAQ
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