Investigator-initiated Phase I BNCT clinical trial for newly diagnosed glioblastoma

We would like to announce that Phase I clinical trial for newly diagnosed glioblastoma started in Japan. The University of Tsukuba submitted the clinical trial protocol notice of this BNCT (Boron Neutron Capture Therapy) investigator-initiated trial with our drug SPM-011.[1]

The Japan Agency for Medical Research and Development (AMED) selected this trial as Translational Research Program.

Glial cells are the major component of central nervous system, existing in between neurons and nerve fibers in the brain and spinal cord. Glioma originated from glial cells comprise the majority of malignant brain tumors. Glioblastomas are considered as the most malignant ones. 

The 5-year survival rate of glioblastomas is only 10%. Despite through treatment combining surgery, radiotherapy and chemotherapy, the risk of recurrence is still very high, and more effective treatment is highly required.

The patient number of brain cancer in Japan is about 20,000 each year, and over 10% of these develop a glioblastoma. The purpose of this trial at the University of Tsukuba is to evaluate the safety and tolerability of the new high-energy neutron source accelerator iBNCT001[2] in combination with SPM-011.

This trial will be an open-labelled and uncontrolled trial[3]. Further details can be referred to the following link below https://jrct.niph.go.jp/en-latest-detail/jRCT2032230554.

Clinical trials with SPM-011 so far mainly targeted patients who already received radiotherapy, , but this trial starts with patients without any history of radiation.

In addition, this trial is designed to prescribe the standard glioblastoma treatment with x-ray radiation and temozolomide chemotherapy after receiving BNCT. Our company strives to expand the indication of BNCT and by achieving that, to give even more patients the possibility of the therapy.

[1] a boron-containing drug for BNCT developed by STELLA PHARMA.

[2] iBNCT001 is an accelerator based on J-PARC’s “linac” (Linear Accelerator). The high-energy device is a research neutron generator specifically designed for BNCT. A beryllium target generates the neutrons at low 8 MeV irradiation. In future it will be able to generate neutrons with the same intensity of a nuclear reactor.

[3] In this trial, doctors and medical personnel know about the treatment groups that patients are assigned to, and there is no control group.