We are pleased to announce the completion of the 90-day observation period for the primary endpoint of the Japanese Phase II clinical trial of BNCT for angiosarcoma※1 that we are conducting with CICS Inc (CICS; a consolidated subsidiary of Resort Trust Co., Tokyo).
The main objective of this study was to evaluate the response rate of BNCT using CICS’s neutron irradiation device (CICS-1) and our boron drug (SPM-011) in patients with unresectable cutaneous angiosarcoma. The study is being conducted at the National Cancer Center Hospital as a single-arm study※2 with 10 patients. Further information can be found following this link.
We strive to expand the target indications of our boron drug SPM-011 through careful analysis and evaluation of the study results.
Borofalan (10B) (SPM-011), which is being developed by our company as a boron agent for BNCT, has been designated as an Orphan Drug※3 by the Ministry of Health, Labour and Welfare in December 2023 for the treatment of unresectable cutaneous angiosarcoma.
※1 About angiosarcoma
Angiosarcoma is cancer that develops endothelial cells of blood vessels. It can occur anywhere in the body but mostly occurs in
the skin.
※2 Single-arm study
A study in which all patients receive the same treatment.
※3 Orphan drug
An orphan drug is a rare disease drug designated by the Minster of Health, Labour and Welfare and is given priority review.
The number of target patients in Japan must be less than 50,000, a serious disease as target and no existing alternative
suitable treatment or drug are also conditions.
Furthermore, the drug’s effectiveness or safety must be expected significantly higher than existing drugs and a high medical
need is required. There must be a theoretical justification for using the drug for the target disease and the development plan
must be accepted as appropriate.
An orphan drug is given preferential review for approval review process and research and development subsidies from the
government.