Alpha Tau reports interim results from trial of Alpha DaRT treatment

Alpha Tau Medical announced the release of interim results from treatment of the first five patients in the Company’s safety and feasibility trial examining the use of Alpha DaRT to treat advanced pancreatic cancer, currently underway at two university hospitals in Montreal, Canada. The first five patients were treated at the Jewish General Hospital, an affiliated teaching hospital of McGill University, Faculty of Medicine in Montreal, Canada, in accordance with the study protocol calling for a pace of approximately one patient per month, pending results from the interim safety read-out from the first five patients. Levels of radium-224 activity were increased from one patient to the next. Tumor stages of the treated patients ranged from stage II to stage IV, and treated tumors were located in the pancreatic head or neck. Four of the five patients had been previously treated with chemotherapy before enrolling in the study. With respect to primary outcome measures, the Alpha DaRT procedure was deemed technically successful in all five cases, with Alpha DaRT sources successfully inserted into the target tumor. In addition, there were no reported serious adverse events deemed related to the product. The only reported adverse events deemed possibly related to the product were of severity grade 1. The first two patients, who had received the fewest number of Alpha DaRT sources, both died approximately three months after treatment, and the deaths were not related to Alpha DaRT treatment. The other three patients, who are still undergoing regular follow-up multiple months after treatment, all demonstrated stable disease responses at four weeks after treatment, i.e., neither material shrinkage nor material increase in the longest dimension of the treated tumor. The third patient treated, for whom the coverage of gross tumor volume at 16 Gy alpha radiation dose was estimated at 44% after treatment, was upgraded to partial response upon evaluation at 69 days after treatment, i.e., the treated tumor shrank by at least 30% on its longest dimension vs. the baseline measurement. The trial seeks to recruit 37 participants who have Stage II to IV pancreatic adenocarcinoma which is deemed inoperable due to non-resectability, metastasis, or lack of fitness for surgery. The study primarily examines the safety and feasibility of placing the Alpha DaRT sources in the tumor utilizing endoscopic ultrasound, and the overall safety of the procedure by measuring adverse events. In addition, the study examines the efficacy of Alpha DaRT in terms of metrics such as overall response rate, overall survival and change in blood levels of CA19-9.