Alpha Tau announces interim data from REGAIN trial

Alpha Tau (DRTS) announced interim data from its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma, also known as the REGAIN trial. In accordance with the FDA’s request for an interim safety analysis, results were analyzed after three patients were treated in the trial, with one patient treated in each of December 2025, February and March. No unanticipated associated SAEs have been observed as of the cutoff date of May 3 and only one associated grade 3 SAE was observed: seizure with temporary paralysis, which resolved with the administration of steroids. In addition, as measured via regular MRI scans and defined by Response Assessment in Neuro-Oncology criteria, the first two patients demonstrated a continued complete response, signifying the total disappearance of all enhancing tumor lesions, and the third patient demonstrated stable disease with a 30% decrease in tumor dimension. As of the cutoff date, no patients have any local or distant recurrence, or any residual symptoms from the procedure, and the patient has recovered from the associated SAE. The first three patients were treated at The Ohio State University Comprehensive Cancer Center in Columbus, Ohio.