Stella Pharma completed the enrollment of patients for the domestic phase II domestic clinical trial of Boron Neutron Capture Therapy (BNCT) on angiosarcoma*1, which is conducted together with CICS Inc. (Tokyo).
The primary objective of this trial is to evaluate the efficacy of BNCT using the neutron irradiation device (CICS-1) of CICS and the boron agent of our company on unresectable, cutaneous angiosarcoma. This trial is conducted at the National Cancer Center Hospital (NCC, Tokyo) as a single-arm trial*2 with 10 patients.
Applicable to this trial are patients with locally advanced, or locally recurrent cancer that are difficult to treat with chemoradiotherapy or radiation therapy. Currently there is no effective local control method and therefore a therapy with a high local control rate is needed. In this situation, Borofalan (10B) being developed as boron drug for BNCT (development code: SPM-011), has been designated as orphan drug*3 for unresectable cutaneous angiosarcoma by the Ministry of Health, Labour and Welfare (MHLW) in December 2023.
By patient observation we will carefully evaluate the results of this trial and then do our best effort to apply for the new indication of the boron drug (SPM-011).
*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 (observation period is 90 days).
*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.