On June 11, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report of the first three patients treated in the trial. The Company intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial.
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As previously announced on May 11, 2026, interim results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure.
This clearance to continue the trial is the latest in a series of successful regulatory submissions to the FDA over more than four years with respect to exploring the use of Alpha DaRT in treating recurrent GBM. In October 2021, the Company was awarded Breakthrough Device Designation by the FDA for Alpha DaRT in recurrent glioblastoma, and in October 2024, the Company was accepted into the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, a highly selective program designed to expedite patient access to highly promising medical devices by providing coveted access to FDA expertise and guidance throughout the device development process.
In parallel with the FDA’s clearance to advance enrollment, Alpha Tau has received FDA authorization for two additional leading U.S. academic cancer centers to join the REGAIN trial as participating sites. The addition of these centers increases the geographic reach of the REGAIN trial, with the aim to broaden access for patients across the United States, and to bring additional multidisciplinary neuro-oncology expertise to the program.
Uzi Sofer, CEO of Alpha Tau, commented, "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 U.S. centers, hopefully brings us meaningfully closer to making Alpha DaRT a real option for these patients."
"I’m very gratified by the FDA’s review of the initial safety assessment and by its clearance to advance to full patient enrollment. What stands out in the early interim data from our first three patients is not just the magnitude of the responses, but their consistency," said Dr. Robert Den, Chief Medical Officer of Alpha Tau. "In recurrent GBM, where objective response rates with most systemic therapies rarely reach double digits, seeing two patients achieve complete disappearance of all enhancing tumor lesions on serial MRI scans as of the cutoff date, while the third showed meaningful tumor volume reduction, is a clinically significant and encouraging pattern. The adverse event profile was manageable: one grade 3 SAE, fully resolved, with no unanticipated toxicities. This is the kind of consistent, interpretable signal that gives us confidence as we advance to the next set of patients."
About the REGAIN Study
The REGAIN study is a prospective, open-label, single-arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM 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. Additional information about the trial can be found at View Source
(Press release, Alpha Tau Medical, JUN 11, 2026, View Source [SID1234666561])