Alpha Tau Announces Treatment of First Prostate Cancer Patient with Alpha DaRT™

JERUSALEM, June 22, 2022 /PRNewswire/ — Alpha Tau Medical Ltd. (Nasdaq: DRTS) (“Alpha Tau”), the developer of innovative alpha radiation cancer therapy Alpha DaRT™, today announced that the first patient has been treated in a feasibility study evaluating the Alpha DaRT as neoadjuvant therapy in patients with prostate cancer at the Rambam Health Care Center in Haifa, Israel.

The main objectives of this study are to evaluate the feasibility and safety of intratumoral implantation of the Alpha DaRT source for the treatment of local prostate cancer before surgery. Secondary objectives include assessment of radiological and pathologic objective tumor response rate and changes in quality of life measures. The study involves two separate procedures, with surgical resection of the prostate 50 days after insertion of the Alpha DaRT source, and can enroll up to 10 patients. The surgical resection will be performed at Carmel Medical Center in Haifa, Israel using a da Vinci® surgical robot, and will be led by Dr. Yuval Freifeld and his senior team.

“This is a historic day for Alpha Tau,” said Alpha Tau CEO Uzi Sofer. “Having gained a wealth of experience in treating superficial cancers such as skin, head and neck and breast, we are delighted to have treated the first prostate patient, our first internal organ treatment. Our preclinical data shows that the Alpha DaRT technology may have the potential to treat a very wide range of solid tumor types, and our strategy is to expand our clinical studies to multiple tumor types to assess the full potential of the ‘Alpha DaRT is a promising treatment beyond superficial tumors and is an important step in executing this strategy.’

Alpha Tau CMO Dr. Robert Den noted, “Since the prostate is surgically removed 50 days after Alpha DaRT insertion, the neoadjuvant design of this trial will allow us to analyze the pathological response of tissues to Alpha DaRT. We hope that This will provide very valuable information to our researchers and allow us to compare theoretical and actual cell damage.”

Dr. Tomer Charas, head of the GU radiation therapy unit in the oncology division of the Rambam Health Care Center in Haifa, Israeland principal investigator of the study, said, “We are thrilled to be leading this trial in collaboration with Carmel’s urology team and to be the first to evaluate Alpha DaRT in prostate cancer patients. Based on the results of preclinical studies, it is possible that neoadjuvant treatment with Alpha DaRT may also trigger an immune response, which could help decrease the risk of tumor recurrence. Additionally, a preferable safety profile has been observed to date in treatments for other tumor types.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to provide highly potent and conformal alpha irradiation of solid tumors by intratumoral administration of radium-224 impregnated sources. As the radium decays, its short-lived progeny are released from the sources and disperse while emitting high-energy alpha particles in an effort to destroy the tumor. Since alpha-emitting atoms only diffuse over a short distance, Alpha DaRT aims to primarily affect the tumor and spare the surrounding healthy tissue.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli medical device company focused on the research, development and potential commercialization of Alpha DaRT for the treatment of solid tumors. The technology was originally developed by Prof. Itzhak Kelson and Prof. yona keisari of Tel Aviv University.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. continue”, and similar expressions are intended to identify forward-looking statements. Further, any statement or information that refers to expectations, beliefs, plans, projections, goals, performance, or other characterizations of future events or circumstances, including any underlying assumptions, is forward-looking. . All forward-looking statements are based on 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 his expectations and his beliefs may not turn out to be correct. Actual results could differ materially from those described or implied by these forward-looking statements due to a variety of important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future product or product candidates; (ii) Alpha Tau’s limited operating history; (iii) the significant losses suffered by Alpha Tau to date; (iv) Alpha Tau’s need for additional funding and its ability to raise capital when needed; (v) Alpha Tau’s limited experience in the discovery and development of medical devices; (vi) Alpha Tau’s dependence on the success and commercialization of Alpha DaRT technology; (vii) the inability of preliminary data from clinical studies of Alpha Tau to predict the final results of the study; (viii) the failure of early clinical studies or preclinical studies of Alpha Tau to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) adverse side effects caused by Alpha Tau’s Alpha DaRT technology or any future product or product candidate; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with numerous regulations applicable to it; (xiii) ability to meet Nasdaq listing standards; (xiv) costs associated with being a public company; (xv) changes in applicable laws or regulations; (xix) impacts of the COVID-19 pandemic; and other important factors discussed under “Risk Factors” in Alpha Tau’s annual report filed on Form 20-F with the SEC on March 28, 2022, and other filings 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. These forward-looking statements represent management’s estimates as of the date of this press release. Whereas Alpha-Tau may choose to update these forward-looking statements at some time in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events change its views. These forward-looking statements should not be taken to represent the views of Alpha Tau as of any date subsequent to the date of this press release.

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SOURCE Alpha Tau Medical

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