Phase I clinical trial for malignant melanoma and angiosarcoma
First written in FY2021. 12 of 20 entries say "Advanced", first in FY2022-Q1. Latest entry: 2026-06-24.
No other company in this theme has enough history to compare yet.
- 2026-06-24Cited as achievedBusiness Plan
「Of the 10 patients who received BNCT, 3 achieved a partial response and 2 achieved a complete response, representing a 50% response rate. The lower bound of the 90% confidence interval met the success criterion set when the clinical trial was planned, and the primary endpoint was achieved.」
The company reiterated that the Phase II trial for angiosarcoma achieved its primary endpoint and that the application was under review, with approval expected by the end of 2026. - FY2026AdvancedAnnual report
「Of the 10 subjects who received BNCT, 3 achieved a partial response and 2 achieved a complete response, resulting in an overall response rate of 50.0% (90% confidence interval: 22.2%-77.8%). As the lower bound of the 90% confidence interval met the success criterion established when the clinical trial was planned, the trial achieved its primary endpoint. Based on these favorable results demonstrating efficacy and safety, in March 2026 the Company filed an application with the Ministry of Health, Labour and Welfare for a partial change to the approved marketing authorization for angiosarcoma.」
The Phase II trial for angiosarcoma confirmed responses in 5 of 10 subjects, an overall response rate of 50.0% and achievement of the primary endpoint, and the Company filed an application for a partial change in March 2026. - FY2026-H1AdvancedAnnual report
「Of the 10 subjects who received BNCT, 3 achieved a partial response and 2 achieved a complete response, resulting in an overall response rate of 50.0% (90% confidence interval: 22.2%-77.8%). The lower bound of the 90% confidence interval met the success criterion established when the clinical trial was planned, and the trial achieved its primary endpoint.」
In the domestic Phase II trial for angiosarcoma, 5 of 10 subjects responded, resulting in an overall response rate of 50.0% and achievement of the primary endpoint. Discussions toward filing for approval in the fiscal year ending March 2026 are under way. - FY2025AdvancedAnnual report
「The Company began a domestic Phase II clinical trial for angiosarcoma in November 2022 and completed it in December 2024.」
The domestic Phase II clinical trial for angiosarcoma was completed in December 2024. - FY2025-H1AdvancedAnnual report
「The Company began a domestic Phase II clinical trial for angiosarcoma in November 2022 and completed subject enrollment for the trial in September 2024.」
The specific progress reported for the domestic Phase II clinical trial for angiosarcoma is that subject enrollment was completed in September 2024. - FY2024-Q3AdvancedAnnual report
「Following discussions with the Ministry of Health, Labour and Welfare regarding angiosarcoma, the Company obtained orphan drug designation in December 2023.」
Development of the domestic Phase II trial for angiosarcoma moved to the stage of obtaining orphan drug designation following discussions with the Ministry of Health, Labour and Welfare. - FY2024-Q2RestatedAnnual report
「The Company began a domestic Phase II clinical trial for angiosarcoma in November 2022 and irradiated the first subject in January 2023. The Company is also discussing with the Ministry of Health, Labour and Welfare the designation of angiosarcoma as an orphan disease drug.」
The Company continues to describe the start of the domestic Phase II trial for angiosarcoma, irradiation of the first subject and discussions toward orphan drug designation. - FY2024-Q1AdvancedAnnual report
「The 90-day observation period for the primary endpoint of the Phase I clinical trial was completed in September 2022. As angiosarcoma accounted for the majority of enrolled patients, the Company determined that BNCT had a higher likelihood of being delivered to clinical practice sooner and began a domestic Phase II clinical trial for angiosarcoma in November 2022. In January 2023, the first subject was irradiated.」
Following completion of the observation period in the Phase I trial, the Company began the Phase II trial for angiosarcoma and irradiated the first subject in January 2023. - FY2023-Q3AdvancedAnnual report
「As angiosarcoma accounted for the majority of enrolled patients, the Company determined that BNCT had a higher likelihood of being delivered to clinical practice sooner and began a domestic Phase II clinical trial for angiosarcoma in November 2022. Going forward, while prioritizing the development of angiosarcoma, the Company will continue considering development of melanoma, including expanding the indications beyond the disease targeted in the Phase I clinical trial.」
Based on the results of the Phase I trial, angiosarcoma was designated as the priority development target and a domestic Phase II trial was initiated. For melanoma, continued consideration, including expansion of the indications, is planned. - FY2023-Q2AdvancedAnnual report
「In Japan, the Company submitted a clinical trial notification in September 2019, and the 90-day observation period for the primary endpoint of the Phase I clinical trial was completed in September 2022.」
In the Phase I clinical trial for melanoma and angiosarcoma, the 90-day observation period for the primary endpoint was completed in September 2022. - FY2023-Q1RestatedAnnual report
「In Japan, the Company submitted a clinical trial notification in September 2019 and is conducting a Phase I clinical trial while proceeding with preparations for a draft plan for the Phase II clinical trial. The trial is being conducted at National Cancer Center Hospital East using the accelerator-based neutron capture therapy system “ＣＩＣＳ-１,” developed by 株式会社ＣＩＣＳ.」
The Company continues to conduct the Phase I trial for melanoma and angiosarcoma and prepare a draft plan for the Phase II trial. - FY2022RestatedAnnual report
「In Japan, the Company submitted a clinical trial notification in September 2019 and is conducting a Phase I clinical trial while proceeding with preparations for a draft plan for the Phase II clinical trial. The trial is being conducted at National Cancer Center Hospital East using the accelerator-based neutron capture therapy system “ＣＩＣＳ-1,” developed by 株式会社ＣＩＣＳ.」
Preparation of the Phase I trial for melanoma and angiosarcoma and the draft plan for the Phase II trial continues. - FY2022-Q3RestatedAnnual report
「In Japan, the Company submitted a clinical trial notification in September 2019 and is conducting a Phase I clinical trial while proceeding with preparations for a draft plan for the Phase II clinical trial. The trial is being conducted at National Cancer Center Hospital East using the accelerator-based neutron capture therapy system “CICS-1,” developed by 株式会社CICS.」
Preparation of the Phase I trial for melanoma and angiosarcoma and the draft plan for the Phase II trial continues. - FY2022-Q2RestatedAnnual report
「In Japan, we submitted a clinical trial notification in September 2019 and are proceeding with preparations for a Phase II clinical trial while conducting a Phase I clinical trial.」
Preparation of the Phase I trial for melanoma and angiosarcoma and the draft plan for the Phase II trial continues. - FY2022-Q1AdvancedAnnual report
「In Japan, we submitted a clinical trial notification in September 2019 and are proceeding with preparations for a Phase II clinical trial while conducting a Phase I clinical trial.」
In addition to conducting the Phase I clinical trial, the study has moved to the stage of preparing a draft plan for the Phase II clinical trial. - FY2021First statedAnnual report
「In addition, the Company began a Phase I clinical trial for melanoma, a type of skin cancer, and angiosarcoma at the National Cancer Center, Japan, as a collaborative clinical trial.」
A new clinical trial has been initiated as a collaborative trial using a thermal neutron generator developed by CICS.