Alpha Tau Receives FDA Approval to Initiate a Trial for Patients with Recurrent Glioblastoma

“This is very exciting news for patients suffering from glioblastoma, a highly aggressive form of brain cancer with an extremely poor prognosis and survival rate. In this trial, we will introduce a completely novel approach, which is specifically designed to deliver Alpha DaRT sources into brain tumors that are not amenable to surgery,” said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. “According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months.”

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment following the Company’s promising results from pre-clinical studies.

“This IDE approval follows the FDA’s continued recognition of the huge promise that this technology holds for patients with recurrent glioblastoma; after having already received the FDA’s Breakthrough Device Designation, followed by acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program to accelerate the Alpha DaRT treatment to market and to the GBM patients who may stand to benefit greatly,” added Alpha Tau Chief Executive Officer Uzi Sofer.