Initiation of a Domestic Phase III Clinical Trial for Recurrent Glioblastoma
STELLA PHARMA CORPORATION (provider of the investigational drug and development entity), Educational Corporation Osaka Medical and Pharmaceutical University (entity conducting the physician-initiated clinical trial), SUMITOMO HEAVY INDUSTRIES,LTD. (provider of the BNCT system and treatment planning program)
Japan, recurrent glioblastoma, borofalan (10B) (SPM-011), BNCT neutron irradiation system (BNCT30), BNCT treatment planning program (DE-01)
The trial was scheduled to formally commence after submission of the treatment plan and completion of the prescribed review process, and those procedures have now been completed.
¥497 million (planned to be allocated to costs related to recurrent malignant glioma; the impact on financial results is immaterial; accounting classification: Not disclosed)
Fiscal year ending March 2027 (impact of this matter on financial results)
The impact of this matter on the Company's financial results for the fiscal year ending March 2027 is immaterial.
Related procedures
Physician-initiated clinical trial (domestic Phase III clinical trial)
The Company will proceed with additional data analysis, preparations for the application and other related measures toward filing for regulatory approval based on the clinical trial results. The clinical trial is scheduled to continue through 30 June 2030.
AltPlusInc. will promptly make an announcement if any matter requiring disclosure arises.
| Item | Details |
|---|---|
| Event name | Initiation of a Domestic Phase III Clinical Trial for Recurrent Glioblastoma |
| Subject Entity | STELLA PHARMA CORPORATION (provider of the investigational drug and development entity), Educational Corporation Osaka Medical and Pharmaceutical University (entity conducting the physician-initiated clinical trial), SUMITOMO HEAVY INDUSTRIES,LTD. (provider of the BNCT system and treatment planning program) |
| Target Locations / Products | Japan, recurrent glioblastoma, borofalan (10B) (SPM-011), BNCT neutron irradiation system (BNCT30), BNCT treatment planning program (DE-01) |
| Cause | The trial was scheduled to formally commence after submission of the treatment plan and completion of the prescribed review process, and those procedures have now been completed. |
| Amount of Impact on Business Performance | ¥497 million (planned to be allocated to costs related to recurrent malignant glioma; the impact on financial results is immaterial; accounting classification: Not disclosed) |
| Accounting period in which recognized | Fiscal year ending March 2027 (impact of this matter on financial results) |
| Impact on Earnings Forecast | The impact of this matter on the Company's financial results for the fiscal year ending March 2027 is immaterial. |
| Type of litigation or proceeding | Physician-initiated clinical trial (domestic Phase III clinical trial) |
| Outlook | The Company will proceed with additional data analysis, preparations for the application and other related measures toward filing for regulatory approval based on the clinical trial results. The clinical trial is scheduled to continue through 30 June 2030. |
| Planned follow-up disclosure | AltPlusInc. will promptly make an announcement if any matter requiring disclosure arises. |
Items this document does not state (15)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The treatment plan has been submitted and the prescribed review process has been completed. Based on the agreement dated 29 January 2026 and the development policy announced on 31 March 2025, the clinical trial will be conducted with support from AMED.