-First two US patients with recurrent cutaneous squamous cell carcinoma have been treated at University Cancer Center in Houston, Texas
-Up to 86 patients to be enrolled in the U.S., Canada, Europe and Israel to assess the efficacy and safety of intratumoral Alpha DaRT for the treatment of patients with recurrent cutaneous squamous cell carcinoma
JERUSALEM, March 08, 2023 (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 that the first two patients were enrolled and treated today in its pivotal multicenter trial, known as the ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The patients were treated at the University Cancer Center in Houston, Texas.
The trial is intended to enroll up to 86 participants who have biopsy-proven recurrent cSCC who are not otherwise indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. The primary study endpoints include overall objective response rate, based on best overall response, duration of response at 6-months from initial observation of a response to Alpha DaRT insertion, and safety of the Alpha DaRT treatment. The study's secondary objectives are to assess the progression-free survival and overall survival at 1-year following Alpha DaRT treatment, overall duration of response, local control, and quality of life. Additional information about the trial can be found at
Alpha Tau CEO Uzi Sofer commented, "Today marks an important milestone for the Company and paves our path forward towards our ultimate goal of U.S. regulatory approval. Moreover, being able to enroll the first two patients simultaneously in one site demonstrates the high unmet need in this patient population and is an important boost in our recruitment efforts. We are hopeful that the results of this study, together with the Breakthrough Device Designation from the FDA for the treatment of this indication, will allow us to gain FDA approval and make the Alpha DaRT treatment available as quickly as possible for patients who suffer from recurrent cSCC. In the coming year, we will continue to focus our efforts on three main areas: swift recruitment in the ongoing ReSTART study, targeting initial results from our internal organ clinical program such as the treatment of pancreatic and prostate cancers, and continued scale-up of our production capacity to allow for smooth and efficient production."
"We remain committed to bringing new hope to patients in this very difficult to treat population. We would like to thank Dr. Mark D'Andrea and Dr. Lawrence Clarke and the dedicated staff at University Cancer Center in Houston for enrolling and treating the first patients in the ReSTART trial and look forward to the forthcoming results," said Alpha Tau Chief Medical Officer, Dr. Robert Den.
Dr. Mark A. D'Andrea, radiation oncologist at University Cancer Center in Houston, commented, "I believe that Alpha DaRT can be a real breakthrough in the treatment of recurrent cSCC. These patients have exhausted the effective treatment options available to them, and Alpha DaRT may give these patients additional hope for a successful outcome. In my experience as a radiation oncologist, treatment with the Alpha DaRT is a quick and straightforward procedure that can often be done in the office setting or procedure room in the clinic without the need for hospitalization or a shielded radiation suite. The procedure is often done using a local anesthetic, with the patient returning after 2 weeks for removal of the sources. The patient should then be able to return to a normal daily routine quickly."
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 medical device 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 28, 2022, 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
-頭兩名美國復發皮膚鱗狀細胞癌患者在大學接受了治療德克薩斯州休斯敦的癌症中心
-在美國、加拿大、歐洲和以色列登記多達86名患者,以評價α-DART瘤內治療復發性皮膚鱗狀細胞癌的療效和安全性
耶路撒冷,2023年3月8日(環球通訊社)--創新的α-放射癌症療法阿爾法-達特™的開發商阿爾法頭醫療有限公司(以下簡稱“阿爾法頭”,或“公司”)宣佈,首批兩名患者今天在其關鍵的多中心試驗中招募和治療,該試驗被稱為RESTART試驗(回復當前%s抄送T用……治療ALpha DartR輻射THerapy),用於治療復發的皮膚鱗癌(CSCC)。這些患者在德克薩斯州休斯頓的大學癌症中心接受治療。
這項試驗旨在招募多達86名經活檢證實為復發性CSCC的參與者,他們沒有其他手術或標準放射治療的適應症,也沒有根治性的系統治療方法。主要研究終點包括基於最佳總體反應的總體客觀反應率、從首次觀察到對阿爾法DART的反應起6個月的反應持續時間,以及阿爾法DART治療的安全性。這項研究的次要目標是評估阿爾法DART治療後1年的無進展存活率和總存活率、總體反應持續時間、局部控制和生活品質。有關試驗的更多資訊,請訪問
Alpha Tau首席執行官尤茲·索弗表示:“今天對公司來說是一個重要的里程碑,為我們邁向美國監管機構批准的最終目標鋪平了道路。此外,能夠在一個地點同時招收前兩名患者表明了這一患者群體中高度未得到滿足的需求,這是我們招募工作的重要推動。我們希望,這項研究的結果,以及FDA指定的用於治療這一適應症的突破設備,將使我們能夠獲得FDA的批准,並儘快將Alpha DART療法用於復發的CSCC患者。在未來的一年裡,我們將繼續將我們的努力集中在三個主要領域:在正在進行的RESTART研究中招募SWIFT,目標是我們的內臟臨床計劃(如治療胰腺癌和前列腺癌)的初步結果,以及繼續擴大我們的生產能力,以實現順利和高效的生產。“
Alpha Tau首席醫療官Robert Den博士說:“我們仍然致力於在這個非常難以治療的人群中為患者帶來新的希望。我們要感謝梅克·丹安德里亞博士和勞倫斯·克拉克博士以及休斯頓大學癌症中心的敬業工作人員在重新啟動試驗中招募和治療第一批患者,並期待即將到來的結果。”
休斯敦大學癌症中心的放射腫瘤學家Mark A.D‘Andrea博士評論說:“我相信Alpha DART可以成為治療復發性CSCC的真正突破。這些患者已經用盡了他們可用的有效治療選擇,Alpha Dart可能會給這些患者帶來額外的成功結局的希望。根據我作為一名放射腫瘤學家的經驗,使用Alpha DART治療是一種快速而簡單的程式,通常可以在辦公室或診所的程式室進行,而不需要住院或屏蔽的輻射套房。手術通常使用局部麻醉劑,患者在2周後返回以去除汙染源。然後,患者應該能夠迅速恢復正常的日常生活。
關於阿爾法飛鏢™
阿爾法DART(擴散阿爾法發射體放射療法)旨在通過瘤內輸送Re-224浸潤源,實現對實體腫瘤的高強度和適形阿爾法照射。當鐳衰變時,其短暫的子體會從源頭釋放出來,並在釋放高能阿爾法粒子的同時消散,目的是摧毀腫瘤。由於發射阿爾法的原子只擴散了很短的距離,阿爾法DART的目標是主要影響腫瘤,並避免其周圍的健康組織。
關於阿爾法頭醫療有限公司
Alpha Tau成立於2016年,是一家以色列醫療器械公司,專注於治療實體腫瘤的Alpha Dart的研究、開發和潛在的商業化。這項技術最初是由特拉維夫大學的Itzhak Kelson教授和Yona Keisari教授開發的。
前瞻性陳述
本新聞稿包括“1995年私人證券訴訟改革法”所指的“前瞻性陳述”。在此使用時,包括“預期”、“正在”、“將”、“計劃”、“可能”、“繼續”和類似表達的詞語旨在識別前瞻性陳述。此外,任何涉及對未來事件或情況的預期、信念、計劃、預測、目標、業績或其他特徵的陳述或資訊,包括任何基本假設,均為前瞻性陳述或資訊。所有前瞻性陳述均基於阿爾法·陶公司目前的預期和各種假設。Alpha Tau認為,其預期和信念是有合理基礎的,但它們本質上是不確定的。Alpha Tau可能無法實現其預期,其信念可能也不會被證明是正確的。由於各種重要因素,實際結果可能與前瞻性陳述中描述的或暗示的大不相同,這些因素包括但不限於:(I)阿爾法-Tau公司獲得監管部門批准其阿爾法-DART技術或任何未來產品或候選產品的能力;(Ii)阿爾法-Tau公司有限的運營歷史;(Iii)Alpha Tau公司迄今遭受的重大虧損;(Iv)Alpha Tau公司對額外資金的需求以及在需要時籌集資金的能力;(V)Alpha Tau公司在醫療器械發現和開發方面的有限經驗;(Vi)Alpha Tau對Alpha Dart技術的成功和商業化的依賴;(Vii)Alpha Tau臨床研究的初步數據未能預測最終研究結果;(Vii)Alpha Tau的早期臨床研究或臨床前研究未能預測未來的臨床研究;(Ix)Alpha Tau招募患者參加臨床試驗的能力;(X)Alpha Tau的Alpha Dart技術或任何未來產品或候選產品造成的不良副作用;(Xi)Alpha Tau面臨專利侵權訴訟;(Xii)Alpha Tau遵守適用於它的廣泛法規的能力;(Xiii)達到納斯達克上市標準的能力;(Xiv)與上市公司相關的成本;(Xv)適用法律或法規的變化;以及在Alpha Tau於2022年3月28日提交給美國證券交易委員會的20-F表格年度報告以及Alpha Tau可能提交給美國證券交易委員會的其他檔案中“風險因素”部分討論的其他重要因素。這些和其他重要因素可能導致實際結果與本新聞稿中的前瞻性陳述所表明的結果大相徑庭。任何此類前瞻性陳述均代表管理層截至本新聞稿發佈之日的估計。雖然Alpha Tau可能會選擇在未來某個時候更新此類前瞻性陳述,但除非法律要求,否則它不承擔任何這樣做的義務,即使隨後發生的事件導致其觀點發生變化。這些前瞻性陳述不應被視為代表Alpha Tau在本新聞稿日期之後的任何日期的觀點。
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