Alpha Tau Medical has received clearance from the US Food and Drug Administration (FDA) to proceed with enrolment of the final seven patients in its REGAIN trial for recurrent glioblastoma (GBM).
The FDA clearance also authorises the inclusion of two additional US academic cancer centres as new sites for the REGAIN trial, expanding its geographical reach and access to multi-disciplinary neuro-oncology expertise.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
This decision follows the FDA’s review of an interim safety report for the first three patients who underwent treatment in the trial.
The trial will evaluate the feasibility and safety of Alpha Tau’s Alpha DaRT for patients with recurrent GBM that is not amenable to surgical resection and who have previously received central nervous system (CNS) radiation.
It is an open-label, single-arm intervention, prospective study and will enrol up to ten US participants.
Preliminary results involved three patients treated between December 2025 and March 2026 at the Ohio State University Comprehensive Cancer Center in Columbus.
The interim analysis reported 100% local disease control, a 67% complete response rate according to Response Assessment in Neuro-Oncology (RANO) criteria, and a grade 3 serious adverse event related to treatment.
No unanticipated serious adverse events were noted, and none of the patients had experienced local or distant recurrence or ongoing symptoms from the procedure as of the data cut-off.
Alpha Tau CEO Uzi Sofer said: “Glioblastoma is one of the most devastating diagnoses in oncology and is a core strategic indication for the company.
“Since the fantastic interim results we released last month from our first three recurrent GBM treatments, clinicians have been overwhelmingly demanding that we keep treating patients as quickly as possible.
“This clearance, combined with the expansion to additional leading US centres, hopefully brings us meaningfully closer to making Alpha DaRT a real option for these patients.”
