SPM-011
What is SPM-011?
SPM-011 is a boron-containing drug for BNCT developed by STELLA PHARMA.
Challenges of BNCT
One of the reasons why BNCT has not been widely used was the need for boron isotope enrichment technology to produce the chemical entity.
Boron isotope enrichment technology
In nature, boron stably exists in two types: 10B (mass number 10) and 11B (mass number 11), and 10B exists only about 20% of boron. The neutron-induced fission reaction used by BNCT to destroy cancer cells is a reaction that occurs only in 10B, and this reaction does not occur in 11B. Boron isotope enrichment technology separates and concentrates only this 10B to a high concentration, and is an indispensable technology for the success of BNCT owned only by our parent company Stella Chemifa in Japan. And we are the only company in the world equipped with the technology necessary to develop drugs exclusively for BNCT.
Development status of SPM-011
As of September 2024
| Head and neck cancer : Obtained marketing and manufacturing approval in 2020, then launched under the product name “STEBORONINE® 9000 mg/300 mL for infusion” |
| Recurrent malignant glioma : Phase II study in Japan from 2016-2019, now in pre-consultation with PMDA |
| Recurrent malignant meningioma : End of observation of Phase II study in Japan (As an investigator-initiated clinical trial) |
| Malignant melanoma : Phase II study in Japan underway |
| angiosarcoma : Phase I study in Japan completed, in consideration to expand the scope of application beyond localized malignant melanoma |
| Newly glioblastoma : Phase I study in Japan underway | Thoracic malignant tumor : Phase I/II study in Japan underway |
