Osaka Medical and Pharmaceutical University Submits Clinical Trial Notification for Phase III Investigator-Initiated Trial Targeting Recurrent Glioblastoma Using Our BNCT System

Sumitomo Heavy Industries, Ltd. (Headquarters: Shinagawa-ku, Tokyo; President and CEO: Toshiro Watanabe; hereinafter 'the Company') announces that Osaka Medical and Pharmaceutical University (Takatsuki City, Osaka; Chairman: Koichi Sano; hereinafter 'OMPU'), a recipient of our BNCT (*1) treatment system, has submitted a clinical trial notification for a 'Phase III investigator-initiated clinical trial of BNCT for recurrent glioblastoma (hereinafter 'this clinical trial').' This clinical trial (*2) is a Phase III study to be conducted using our BNCT neutron irradiation system (BNCT30) and BNCT treatment planning program (DE-01), as well as Borofalan (10B) (SPM-011) provided by Stella Pharma Corporation. Glioblastoma is the most malignant among gliomas, and especially in cases of recurrence, treatment options are limited, and it remains a disease with a poor prognosis. This clinical trial aims to verify the efficacy and safety of BNCT for recurrent glioblastoma and to establish a new treatment option. The Company will cooperate with OMPU to ensure the smooth implementation of this clinical trial. ■ Outline of this Clinical Trial Target Disease: Recurrent Glioblastoma (IDH wild-type) Objective: To verify the clinical efficacy of BNCT using SPM-011, BNCT30, and DE-01 in patients with a history of treatment with radiation therapy and temozolomide. Implementing Institutions: Osaka Medical and Pharmaceutical University Hospital (subject registration/assignment, evaluation observation, survival survey); Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University (investigational drug administration, BNCT implementation) Contract Period: Until June 30, 2030 Clinical Trial Detailed Information: https://jrct.mhlw.go.jp/latest-detail/jRCT2051260030 (*1) BNCT (Boron Neutron Capture Therapy) is a new cancer radiation therapy that can selectively destroy cancer cells. After administering a BNCT boron agent that is selectively taken up by cancer cells, low-energy neutrons are irradiated from outside the body, and the resulting alpha particles and Li particles from the nuclear reaction between boron and neutrons destroy the cancer cells. (*2) This announcement is not intended to solicit participants for this clinical trial or to recommend medical consultation. End