Alpha Tau Announces FDA Approval of IDE Supplement to Expand Pilot Trial of Alpha DaRT® to Thirty Patients with Pancreatic Cancer in Two Cohorts, with Locally Advanced or Metastatic Disease
Alpha Tau Medical (NASDAQ: DRTS) has received FDA approval for an IDE supplement to expand its pilot trial of Alpha DaRT® cancer therapy. The expanded study will now include 30 total patients across two cohorts: patients with locally advanced pancreatic cancer and those with metastatic pancreatic cancer. This represents an increase from the previously announced 12-patient study examining Alpha DaRT combined with first-line chemotherapy in newly diagnosed metastatic pancreatic cancer patients.
The expanded trial will be conducted across up to 10 U.S. clinical trial sites, with each cohort consisting of 15 patients. This expansion follows recently released data showing positive results in disease control and overall survival for pancreatic cancer patients treated with Alpha DaRT.
Alpha Tau Medical (NASDAQ: DRTS) ha ricevuto l'approvazione della FDA per un'integrazione IDE per espandere il suo studio pilota della terapia oncologica Alpha DaRT®. Lo studio ampliato includerà ora 30 pazienti totali suddivisi in due coorti: pazienti con carcinoma pancreatico localmente avanzato e pazienti con carcinoma pancreatico metastatico. Questo rappresenta un aumento rispetto allo studio precedente di 12 pazienti che esaminava l'uso di Alpha DaRT in combinazione con la chemoterapia di prima linea in pazienti con carcinoma pancreatico metastatico diagnosticato di recente.
Il trial ampliato sarà condotto in fino a 10 siti di sperimentazione clinica negli Stati Uniti, con ciascuna coorte che consisterà in 15 pazienti. Questa espansione segue dati recentemente pubblicati che mostrano risultati positivi nel controllo della malattia e nella sopravvivenza complessiva per i pazienti affetti da carcinoma pancreatico trattati con Alpha DaRT.
Alpha Tau Medical (NASDAQ: DRTS) ha recibido la aprobación de la FDA para un suplemento IDE para expandir su ensayo piloto de la terapia contra el cáncer Alpha DaRT®. El estudio ampliado ahora incluirá 30 pacientes en total distribuidos en dos cohortes: pacientes con cáncer de páncreas localmente avanzado y aquellos con cáncer de páncreas metastásico. Esto representa un aumento con respecto al estudio previamente anunciado de 12 pacientes que examinó Alpha DaRT combinado con quimioterapia de primera línea en pacientes recién diagnosticados con cáncer de páncreas metastásico.
El ensayo ampliado se llevará a cabo en hasta 10 sitios de ensayo clínico en EE. UU., con cada cohorte consistiendo en 15 pacientes. Esta expansión sigue a datos recientemente publicados que muestran resultados positivos en el control de la enfermedad y la supervivencia general de los pacientes con cáncer de páncreas tratados con Alpha DaRT.
알파 타우 메디칼 (NASDAQ: DRTS)는 알파 다르트® 암 치료의 파일럿 시험을 확장하기 위한 IDE 보충을 FDA로부터 승인받았습니다. 확장된 연구는 이제 총 30명의 환자를 두 개의 집단으로 나누어 포함할 것입니다: 국소 진행성 췌장암 환자와 전이성 췌장암 환자. 이는 최근 진단된 전이성 췌장암 환자에서 1차 화학요법과 결합된 Alpha DaRT를 조사하는 12명의 환자 연구에서 늘어난 것입니다.
확장된 시험은 최대 미국 내 10개의 임상 시험 사이트에서 수행될 예정이며, 각 집단은 15명의 환자로 구성됩니다. 이 확장은 Alpha DaRT 치료를 받은 췌장암 환자의 질병 조절과 전체 생존에서 긍정적인 결과를 보여준 최근 발표된 데이터에 따른 것입니다.
Alpha Tau Medical (NASDAQ: DRTS) a reçu l'approbation de la FDA pour un complément IDE afin d'élargir son essai pilote de thérapie cancéreuse Alpha DaRT®. L'étude élargie comprendra maintenant 30 patients au total répartis en deux cohortes : des patients atteints de cancer du pancréas localement avancé et ceux atteints de cancer du pancréas métastatique. Cela représente une augmentation par rapport à l'étude précédente de 12 patients qui examinait Alpha DaRT combiné avec une chimiothérapie de première ligne chez des patients récemment diagnostiqués avec un cancer du pancréas métastatique.
L'essai élargi sera mené dans jusqu'à 10 sites d'essai clinique aux États-Unis, chaque cohorte étant composée de 15 patients. Cette expansion fait suite à des données récemment publiées montrant des résultats positifs en matière de contrôle de la maladie et de survie globale pour les patients atteints de cancer du pancréas traités par Alpha DaRT.
Alpha Tau Medical (NASDAQ: DRTS) hat die Genehmigung der FDA für eine IDE-Ergänzung erhalten, um seine Pilotstudie zur Alpha DaRT® Krebstherapie zu erweitern. Die erweiterte Studie wird jetzt insgesamt 30 Patienten in zwei Kohorten umfassen: Patienten mit lokal fortgeschrittenem Bauchspeicheldrüsenkrebs und solche mit metastasiertem Bauchspeicheldrüsenkrebs. Dies stellt eine Erhöhung gegenüber der zuvor angekündigten Studie mit 12 Patienten dar, die Alpha DaRT in Kombination mit einer Erstlinienchemotherapie bei neu diagnostizierten Patienten mit metastasiertem Bauchspeicheldrüsenkrebs untersuchte.
Die erweiterte Studie wird an bis zu 10 klinischen Prüfungsstandorten in den USA durchgeführt, wobei jede Kohorte aus 15 Patienten besteht. Diese Erweiterung folgt auf kürzlich veröffentlichte Daten, die positive Ergebnisse bei der Krankheitskontrolle und der Gesamtüberlebensrate für Patienten mit Bauchspeicheldrüsenkrebs zeigen, die mit Alpha DaRT behandelt wurden.
- FDA approval to expand clinical trial from 12 to 30 patients
- Addition of new patient cohort (locally advanced pancreatic cancer)
- Expansion to up to 10 U.S. clinical trial sites
- Recent positive data in disease control and overall survival
- None.
Insights
The FDA's approval to expand Alpha Tau's pancreatic cancer trial marks a crucial milestone in the development of Alpha DaRT® therapy. Pancreatic cancer, with its dismal 5-year survival rate of under
The strategic decision to expand to 10 U.S. clinical sites serves multiple purposes: it accelerates patient recruitment, builds relationships with key opinion leaders and establishes a broader foundation for potential commercialization. This multi-center approach typically strengthens FDA submissions by demonstrating reproducibility across different clinical settings.
From a regulatory perspective, the rapid IDE supplement approval, following positive preliminary data, suggests the FDA's recognition of Alpha DaRT's potential benefit in a high-mortality indication. This expedited timeline could indicate a smoother pathway through subsequent regulatory stages, particularly if the technology maintains its promising efficacy profile.
For investors, this development carries several positive implications: 1) The expanded trial scope reduces single-cohort risk while potentially accelerating the path to market, 2) The multi-center approach builds valuable institutional relationships for future commercialization and 3) The FDA's swift response suggests regulatory receptivity to the technology's potential in addressing this critical unmet need.
JERUSALEM, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients.
The IDE supplement allows the Company to include an additional cohort for locally advanced pancreatic cancer patients, and to increase the number of each cohort to 15 patients, for a total of 30 patients across the two cohorts, at up to 10 U.S. clinical trial sites.
Alpha Tau CEO Uzi Sofer commented, “Following the incredible data that we released last week, analyzing disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT, we welcome the news of this IDE supplement as we continue to move forward, full steam ahead, in our efforts to explore a new treatment for patients with this deadly disease as quickly as possible.”
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau 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.
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.
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 7, 2024, 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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