Alpha Tau Expands Alpha DaRT Treatment to Vulvar Cancer in Cambridge University Trial

Pioneering Clinical Trial at Cambridge University Explores Alpha DaRT Treatment for Vulvar Cancer

Alpha Tau Medical Ltd. has initiated a feasibility and safety study for their alpha-radiation cancer therapy, Alpha DaRT, with the treatment of the first patient diagnosed with squamous cell carcinoma of the vulva at Addenbrookes Hospital, part of the Cambridge University Hospitals NHS Foundation Trust in Cambridge, England.

In an investigator-initiated trial, Alpha Tau Medical aims to enroll 10 participants with newly diagnosed or locally recurrent vulva cancer, with or without distant metastases. The primary objectives of the study are to evaluate the safety and feasibility of Alpha DaRT treatment. This will be achieved by assessing treatment-related adverse events during the 6-month follow-up period. The trial will also investigate the efficacy of Alpha DaRT by measuring tumor response after 4 weeks of treatment using RECIST criteria, histological evidence of necrosis in pathological lymph nodes (if removed), and percentage of necrotic tissue (if residual tumor is surgically removed) at 4-6 weeks. Additionally, the study will analyze the local control rate during 3-month and 6-month follow-up visits, patient-rated pain score, mental state, and physical state over the 6-month follow-up period.

Uzi Sofer, the CEO of Alpha Tau, expressed his enthusiasm for the initiation of the trial, emphasizing the company's commitment to addressing clinical indications with significant unmet medical needs. He extended his gratitude to Dr. Li Tee Tan at Addenbrookes Hospital, part of the Cambridge University Hospitals NHS Foundation Trust, for enrolling and treating the first patient in this groundbreaking feasibility and safety trial. Sofer emphasized that this trial serves as a crucial step in Alpha Tau's broader strategy to expand the application of Alpha DaRT in challenging indications such as brain, pancreas, lung, and breast cancers. He eagerly awaits the preliminary results, which he hopes will further advance the utilization of Alpha DaRT in diverse indications, ultimately benefiting patients worldwide.

Li Tee Tan, MBBS, FRCR, MRCP, MD, a Consultant Clinical Oncologist at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, and the principal investigator of the trial, expressed their enthusiasm regarding the treatment of the first patient in the trial. They highlighted the significant progress this represents in the management of vulva cancer, as conventional treatment often involves extensive and potentially disfiguring surgery. They further explained that depending on the disease's extent and location, surgical interventions can lead to significant complications and life-altering consequences for patients. Tan expressed hope that the innovative and promising Alpha DaRT therapy could offer improved outcomes for individuals with this challenging disease. They expressed gratitude to Alpha Tau Medical Ltd. and the CCTU-Cancer Theme for their support in initiating the trial and for facilitating a straightforward procedure for Alpha DaRT insertion into the cancerous lesion.

Published on : 18th May, 2023