Osaka Medical and Pharmaceutical University Submits Clinical Trial Notification for Phase III Investigator-Initiated Trial Targeting Recurrent Glioblastoma Using Our BNCT System
Osaka Medical and Pharmaceutical University, a client of Sumitomo Heavy Industries' BNCT treatment system, has submitted a clinical trial notification for a Phase III investigator-initiated trial for recurrent glioblastoma. This trial will use our BNCT equipment and a boron agent from Stella Pharma Corporation to establish a new treatment option. We will cooperate with the university to ensure the smooth implementation of the trial.
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- 📰 Published: May 18, 2026 at 20:00
- 🔍 Collected: May 18, 2026 at 11:31
- 🤖 AI Analyzed: May 18, 2026 at 11:35 (4 min after Collected)
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
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