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Completion of Enrollment in 1st US Clinical Trial & Achievement of 1st Primary Objective




JERUSALEM, Oct. 25, 2021 -- Alpha Tau Medical Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that its US pilot trial for skin cancer has completed enrollment as planned. This announcement comes less than four months after the first patient was recruited into the trial in July 2021. Alpha DaRT sources were successfully implanted into all patients and then removed two to three weeks later as scheduled, and no serious adverse events related to the Alpha DaRT were noted at the time of removal. As such, the trial has met its first primary objective, in demonstrating feasibility of successful delivery of the Alpha DaRT. With respect to its co-primary objective of assessing the frequency and severity of acute adverse events related to the Alpha DaRT, treatment-related adverse events seen thus far have been in line with those seen in previous human trials of the Alpha DaRT and will be monitored throughout the remainder of the follow-up period. Tumor response, a secondary objective of the trial, will be assessed in each patient three months after Alpha DaRT removal.


The pilot study is designed to evaluate the feasibility of Alpha DaRT in treating ten subjects with malignant skin and superficial soft tissue tumors. The primary objectives are to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using Alpha DaRT, with a goal of achieving successful delivery in at least seven of the ten patients, as well as to determine the frequency and severity of acute adverse events. Secondary objectives include assessments of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and quality of life measures. The trial is being conducted in multiple sites across the U.S.

Alpha Tau CEO Uzi Sofer remarked, "We are thrilled about having reached this major milestone for the company, with the completion of recruitment for our first U.S. trial, and are appreciative of all of our trial site investigators, whose excitement for the tremendous potential of the Alpha DaRT helped us recruit patients swiftly. With our Breakthrough Device Designation for the treatment of certain patients with squamous cell carcinoma assisting our navigation of potential FDA regulatory pathways, we look forward to potentially moving into a U.S. pivotal trial in 2022, with the goal of bringing the Alpha DaRT closer to availability for patients around the country as quickly as possible."


"The novelty of the Alpha DaRT has sparked great excitement in the U.S. oncology community as evidenced by our brisk accrual," said Alpha Tau CMO, Dr. Robert Den. "We look forward to our forthcoming pivotal trial as we strive to bring this revolutionary technology to the market."


About Alpha DaRT