Alpha Tau Expands its Alpha DaRT Treatment to Vulvar Cancer in Novel Clinical Trial with Cambridge University

JERUSALEM, May 17, 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 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.”