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Alpha Tau Treats First Patient with Recurrent Lung Cancer

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Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has treated its first patient with recurrent lung cancer using the Alpha DaRT® therapy at Hadassah Medical Center in Jerusalem, Israel. The clinical trial aims to treat up to ten patients with recurrent tumors in the mediastinum area, allowing concurrent use of other therapies if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, as well as evaluate the efficacy of Alpha DaRT for this indication.

Lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected annually. In the U.S., it's the third most common cancer, with an estimated 210,000 new cases per year. The Alpha DaRT treatment offers a potential new approach for patients with treatment options, especially those who have already undergone conventional radiation therapy.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) ha trattato il suo primo paziente con cancro polmonare ricorrente utilizzando la terapia Alpha DaRT® presso il Hadassah Medical Center a Gerusalemme, Israele. Lo studio clinico mira a trattare fino a dieci pazienti con tumori ricorrenti nell'area mediastinica, consentendo l'uso simultaneo di altre terapie se necessario. La ricerca valuterà la sicurezza e la fattibilità della somministrazione delle sorgenti Alpha DaRT nei polmoni utilizzando una procedura di ultrasuoni endobronchiali (EBUS), nonché valuterà l'efficacia di Alpha DaRT per questa indicazione.

Il cancro ai polmoni è la principale causa di decessi legati al cancro in tutto il mondo, con quasi 2,5 milioni di nuovi casi rilevati ogni anno. Negli Stati Uniti, è il terzo tipo di cancro più comune, con circa 210.000 nuovi casi all'anno. Il trattamento Alpha DaRT offre un potenziale nuovo approccio per i pazienti con opzioni terapeutiche, specialmente per coloro che hanno già ricevuto una terapia radiante convenzionale.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) ha tratado a su primer paciente con cáncer de pulmón recurrente utilizando la terapia Alpha DaRT® en el Centro Médico Hadassah en Jerusalén, Israel. El ensayo clínico tiene como objetivo tratar hasta diez pacientes con tumores recurrentes en el área mediastínica, permitiendo el uso concurrente de otras terapias si se indica. El estudio evaluará la seguridad y viabilidad de administrar fuentes de Alpha DaRT en los pulmones mediante un procedimiento de ecografía endobronquial (EBUS), así como evaluará la eficacia de Alpha DaRT para esta indicación.

El cáncer de pulmón es la principal causa de muertes relacionadas con el cáncer en todo el mundo, con casi 2.5 millones de nuevos casos detectados anualmente. En los EE. UU., es el tercer cáncer más común, con un estimado de 210,000 nuevos casos por año. El tratamiento Alpha DaRT ofrece un nuevo enfoque potencial para pacientes con opciones de tratamiento, especialmente para aquellos que ya han recibido terapia de radiación convencional.

알파 타우 의학( NASDAQ: DRTS, DRTSW )은 이스라엘 예루살렘의 하다사 병원에서 알파 다르트(Alpha DaRT®) 요법을 사용하여 재발성 폐암 환자를 처음으로 치료했습니다. 이 임상 시험은 중재부위에 있는 재발 종양으로 고통받는 최대 10명의 환자를 치료하는 것을 목표로 하며, 필요한 경우 다른 치료법의 동시 사용을 허용합니다. 이 연구는 폐 내에서 알파 다르트 소스를 제공하는 데 있어 안전성과 실행 가능성을 평가할 것이며, 이 적응증에 대한 알파 다르트의 효능을 평가할 것입니다.

폐암은 전 세계적으로 암 관련 사망의 주요 원인이며, 매년 거의 250만 건의 새로운 사례가 발견됩니다. 미국에서는 세 번째로 흔한 암으로, 매년 약 21만 건의 신규 사례가 추정됩니다. 알파 다르트 치료는 특히 기존 방사선 요법을 받은 환자에게 치료 옵션이 있는 환자들에게 잠재적인 새로운 접근 방식을 제공합니다.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) a traité son premier patient atteint d'un cancer du poumon récurrent en utilisant la thérapie Alpha DaRT® au Hadassah Medical Center à Jérusalem, en Israël. L'essai clinique vise à traiter jusqu'à dix patients ayant des tumeurs récurrentes dans la zone médiastinale, permettant l'utilisation simultanée d'autres thérapies si nécessaire. L'étude évaluera la sécurité et la faisabilité de l'administration de sources Alpha DaRT dans les poumons à l'aide d'une procédure d'échographie endobronchique (EBUS), ainsi que l'efficacité de l'Alpha DaRT pour cette indication.

Le cancer du poumon est la principale cause de décès liés au cancer dans le monde, avec près de 2,5 millions de nouveaux cas détectés chaque an. Aux États-Unis, c'est le troisième cancer le plus fréquent, avec environ 210 000 nouveaux cas par an. Le traitement Alpha DaRT propose une nouvelle approche potentielle pour les patients avec des options de traitement, en particulier ceux qui ont déjà subi une radiothérapie conventionnelle.

Alpha Tau Medical (NASDAQ: DRTS, DRTSW) hat seinen ersten Patienten mit wiederkehrendem Lungenkrebs mit der Alpha DaRT®-Therapie am Hadassah Medical Center in Jerusalem, Israel, behandelt. Die klinische Studie zielt darauf ab, bis zu zehn Patienten mit wiederkehrenden Tumoren im Mediastinum zu behandeln und erlaubt die gleichzeitige Anwendung anderer Therapien, falls angezeigt. Die Studie wird die Sicherheit und Durchführbarkeit der Verabreichung von Alpha DaRT-Quellen in die Lunge mithilfe eines Endobronchial-Ultraschallverfahrens (EBUS) bewerten sowie die Wirksamkeit von Alpha DaRT für diese Indikation untersuchen.

Lungenkrebs ist die häufigste Ursache für krebsbedingte Todesfälle weltweit, mit fast 2,5 Millionen neu diagnostizierten Fällen jährlich. In den USA ist er die dritthäufigste Krebsart mit schätzungsweise 210.000 neuen Fällen pro Jahr. Die Alpha DaRT-Behandlung bietet einen potenziellen neuen Ansatz für Patienten mit Behandlungsoptionen, insbesondere für solche, die bereits eine konventionelle Strahlentherapie erhalten haben.

Positive
  • First patient with recurrent lung cancer treated using Alpha DaRT therapy
  • Clinical trial initiated to assess safety and efficacy of Alpha DaRT for lung cancer
  • Potential new treatment option for patients with alternatives
  • Expansion of Alpha DaRT application to visceral organs and complex cases
Negative
  • None.

Insights

The treatment of the first recurrent lung cancer patient with Alpha DaRT marks a significant milestone for Alpha Tau Medical. This clinical trial at Hadassah Medical Center aims to assess the safety, feasibility and efficacy of Alpha DaRT in treating recurrent mediastinal tumors using an endobronchial ultrasound (EBUS) procedure.

Key points to consider:

  • The trial allows for concurrent use of chemotherapy, targeted therapy, or immunotherapy, potentially enhancing treatment outcomes.
  • Lung cancer is the leading cause of cancer-related deaths globally, with 2.5 million new cases annually, often diagnosed at advanced stages.
  • Alpha DaRT's ability to target tumors while minimizing damage to surrounding healthy tissue could be particularly beneficial in complex cases like lung cancer.
  • The use of EBUS-guided implantation demonstrates the versatility of Alpha DaRT in reaching challenging tumor locations.

This development could potentially open new treatment avenues for lung cancer patients with options, especially those who have already undergone conventional radiation therapy. However, it's important to await the full trial results to assess the treatment's effectiveness and safety profile in this new application.

The application of Alpha DaRT to recurrent lung cancer represents a promising advancement in targeted radiation therapy. The alpha-emitting particles offer a unique advantage in their ability to deliver highly localized radiation, which is particularly valuable in sensitive areas like the lungs.

Several aspects of this development are noteworthy:

  • The use of EBUS for source placement demonstrates an innovative approach to accessing hard-to-reach tumors.
  • The allowance for concurrent therapies suggests a potential for synergistic effects, which could enhance overall treatment efficacy.
  • The focus on recurrent tumors addresses a critical need, as these cases often have treatment options and poor prognoses.

While this first treatment is encouraging, it's important to note that the trial is small (up to 10 patients) and primarily focused on safety and feasibility. Efficacy data, particularly the tumor response at one and three months, will be important in determining the potential of Alpha DaRT for lung cancer treatment. The medical community will be keenly watching for results on tumor coverage and any treatment-related adverse events, especially given the proximity to vital organs.

JERUSALEM, Oct. 10, 2024 (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 that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel.

The trial is designed to treat up to ten patients with recurrent tumors in the mediastinum area of the chest, and allows for the use of concurrent chemotherapy, targeted therapy, or immunotherapy, if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, including by observing the rate of successful source placement and any treatment-related adverse events. In addition, the study will also assess the efficacy of Alpha DaRT for this indication by examining tumor response at one and three months after source insertion using RECIST criteria, as well as tumor coverage. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT05632913.

According to the WHO’s International Agency for Research on Cancer, lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected each year, and is often only diagnosed at advanced stages, when treatment options are limited.In the U.S.,lung cancer is the third most common cancer, according to the Centers for Disease Control and Prevention, with an estimated 210,000 new cases per year.

“Alpha Tau continues to forge ahead with the application of Alpha DaRT to a broader set of indications, particularly in tumors in visceral organs and other complex cases,” said Alpha Tau Chief Executive Officer Uzi Sofer. “As we see continued clinician excitement and demand for use of the Alpha DaRT in an ever-increasing set of cancers, the ability to start treating patients in as terrible and widespread an illness as lung cancer is particularly meaningful.”

“The Institute of Pulmonology of Hadassah Medical Center is excited to utilize this groundbreaking EBUS-guided implantable alpha radiation technology to treat a patient with lung cancer for the first time,” noted Prof. Neville Berkman, MD, the study principal investigator and Director of the Institute of Pulmonology and Head of Adults and Invasive Pulmonology Unit, Hadassah Medical Center, who treated the patient. “The treatment makes use of bronchoscopic endobronchial ultrasound to insert the Alpha DaRT sources. We look forward to further examining the promise of what the Alpha DaRT treatment can offer lung cancer patients and their families.”

“Treating the first lung patient with the Alpha DaRT is a very exciting moment. We have already demonstrated the advantages of the Alpha DaRT technology in a number of other tumor types, but examining its application to an organ such the lung, given its proximity to vital healthy organs, may hopefully open new doors to a global population of patients with otherwise poor treatment options,” commented Alpha Tau Chief Medical Officer Robert Den, MD.

“Treating the first patient with lung cancer using Alpha DaRT marks a significant advancement, introducing a novel approach that combines the precision of alpha-emitting particles with the ability to selectively target and destroy tumor cells while minimizing damage to surrounding healthy tissues,” added Dr. Philip Blumenfeld, study co-investigator and Senior Radiation Oncologist and Head of Thoracic Radiation Oncology Services at Hadassah Medical Center. “In this specific case, the patient had already undergone conventional radiation therapy to the lung and lymph nodes, and additional radiation would have posed a high risk of serious harm to nearby structures, particularly the esophagus and bronchus.”

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 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 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

What is the purpose of Alpha Tau's clinical trial for lung cancer using Alpha DaRT?

The clinical trial aims to assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, as well as evaluate the efficacy of Alpha DaRT for recurrent lung cancer in the mediastinum area.

How many patients will be treated in Alpha Tau's lung cancer trial with Alpha DaRT (DRTS)?

The clinical trial is designed to treat up to ten patients with recurrent tumors in the mediastinum area of the chest.

What is the significance of treating lung cancer with Alpha DaRT (DRTS)?

Treating lung cancer with Alpha DaRT is significant because lung cancer is the leading cause of cancer-related deaths worldwide, and this therapy offers a potential new approach for patients with treatment options, especially those who have already undergone conventional radiation therapy.

Where is Alpha Tau's first lung cancer patient being treated with Alpha DaRT (DRTS)?

The first patient with recurrent lung cancer is being treated with Alpha DaRT at Hadassah Medical Center in Jerusalem, Israel.

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