-First patient treated in the feasibility and safety study of intratumoral diffusing alpha-emitters radiation therapy (Alpha DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva.
JERUSALEM, May, 17, 2023 -- 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 squamous cell carcinoma of the vulva has been treated in a feasibility and safety study of Alpha DaRT at Addenbrookes Hospital of the Cambridge University Hospitals NHS Foundation Trust in Cambridge, England.
The investigator-initiated trial seeks to recruit 10 participants who have newly diagnosed or locally recurrent vulva cancer with or without distant metastases. The study will assess the safety and feasibility of using the Alpha DaRT by measuring the treatment-related adverse events in the 6-month follow-up period. In addition, the study will also examine the efficacy of Alpha DaRT in terms of tumor response at 4 weeks after Alpha DaRT insertion using RECIST criteria, histological evidence of necrosis in pathological lymph nodes (if removed) and percentage of necrotic tissue (if residual tumor is removed surgically) at 4-6 weeks, local control rate at 3-month and 6-month follow up visits, patient-rated pain score, mental state and physical state over the 6-month follow up period. Additional information about the trial can be found at https://clinicaltrials.gov/ct2/show/NCT04761146.
Alpha Tau CEO Uzi Sofer commented, “The initiation of this trial is a perfect example of how Alpha Tau is forging ahead in our strategy to address clinical indications of high unmet medical need. We would like to thank Dr. Li Tee Tan at Addenbrookes Hospital of the Cambridge University Hospitals NHS Foundation Trust for enrolling and treating the first patient in this pioneering feasibility and safety trial.” Mr. Sofer added, “This trial is an important building block in the foundation of our overall strategy to broaden the use of the Alpha DaRT in other hard-to-treat indications such as cancers of the brain, pancreas, lung, and breast. We look forward to the preliminary results of this trial, which we hope will further our goals of advancing the use of Alpha DaRT across a range of indications and helping patients worldwide.”
Li Tee Tan, MBBS, FRCR, MRCP, MD, Consultant Clinical Oncologist at Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust and the principal investigator of the trial, commented, “The treatment of this first patient represents a major new advance in the treatment of this disease. Patients with this disease are usually faced with major and potentially deformative surgery as standard treatment. However, depending on the extent and location of disease, the short and long-term complications of surgery are often significant and can be life changing. We are hopeful that treatment with the novel and promising Alpha DaRT may offer better outcomes to these patients with such a challenging disease. We appreciate the support from Alpha Tau Medical Ltd. and the CCTU-Cancer Theme for opening this trial and for securing a straightforward procedure for Alpha DaRT insertion into the cancerous lesion.”
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.
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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 9, 2023, 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.