Our company provides the boron drug for BNCT (Boron Neutron Capture Therapy), which is conducted at Osaka Medical and Pharmaceutical University Hospital, located in Takatsuki City, Osaka Prefecture. SPM-011, our drug, is also used in the domestic investigator-initiated phase II clinical trial [1] at that hospital, for which the observation period for the primary endpoint has been completed.
The randomized controlled study is aiming to evaluate the efficacy and safety of BNCT for patients with recurrent high-grade meningioma[2] (WHO grade 2 and 3). The PFS (progression-free survival) based on the imaging response assessment at the centralized facility is the primary endpoint of this study (further information can be found following this link: 臨床研究等提出・公開システム (niph.go.jp)).
We strive to expand the target indications of our boron drug SPM-011 through careful analysis and evaluation of the study results.
[1]Investigator-initiated clinical trial
In an investigator-initiated clinical trial, the physician personally develops and conducts the clinical trial plan and design including the clinical trial protocol notice required for the manufacturing and sales approval.
The achieved data will then be taken over by the pharmaceutical manufacturer that provided the clinical trial material, and this manufacturer will include these data in the application for regulatory approval of the drug.
[2]Recurrent high-grade meningioma
Meningiomas are categorized into one type of brain tumors that develops in one of the inner layers of the meninges, which are thin layers of tissue that protect the brain and spinal cord. The most common kind of meningioma is benign (WHO grade 1), but if highly malignant (WHO grade 2 or 3), it can deeply invade the brain, cerebrovascular vessels, the skull and recur repeatedly. If recurrent, surgery or radiotherapy (external x-ray radiation) are applicable, but the results are limited and there is no effective treatment developed yet.