BNCT with accelerator in clinical trials

Commencement of Clinical Trials (Phase II Trials) for a Boron Neutron Capture Therapy (BNCT) System that Combines a Cyclotron Neutron Irradiation System with a Boron Compound.

Sumitomo Heavy Industries, Ltd. (President and CEO: Shunsuke Betsukawa; hereinafter referred to as “SHI” or the “Company”) and Stella Pharma Corporation (President and CEO: Tomoyuki Asano; hereinafter referred to as “Stella Pharma”) jointly announced today that they would commence Phase II Clinical Trials by BNCT (hereinafter referred to as the “Trial”) for recurrent glioblastoma. The two companies further announced that the trials would be carried out at Southern TOHOKU Research Institute for Neuroscience (CEO, President and Chairman: Dr. Kazuo Watanabe). The subject patients of the Trial are those that have had a recurrence of glioblastoma, a type of malignant brain tumor with one of the worst prognoses among cancers. The patient of the Trial will have to have gone through various forms of oncological treatment including tumorectomy, radiation therapy, and treatment with anticancer drug such as temozolomide. The Trial commences in January 2016, with 24 recurrent glioblastoma patients. In 2012, the Phase I Clinical Trials of the effectiveness of BNCT against recurring malignant glioma were carried out at the Kyoto University Research Reactor Institute (KURRI) and the Osaka Medical College. At the time, the trial was able to verify the safety and tolerability of the maximum dose of BNCT. Based on this research, the Company and Stella Pharma plan to verify the effectiveness of BNCT in the current Trial, using the maximum dose.

BNCT* is a type of cancer treatment that aims to selectively destroy cancer cells in which a boron (Boron-10) compound was administrated by irradiating such cells with a very low energy neutron beam to cause a nuclear reaction. This unique radiation therapy is different from other radiation therapies, as it is capable of destroying only cancer cells in principle, whereas normal cells in the vicinity are seldom harmed. Conventional BNCT involve the use of an experimental nuclear reactor to produce neutrons. However, this BNCT system uses a cyclotron neutron irradiation system that was jointly developed by SHI and KURRI instead of a nuclear reactor to produce neutrons, which makes it possible to install the system in a hospital. It is therefore expected that this significant advancement will lead to a rise in the popularity in the use of BNCT systems in the future.

*BNCT is an abbreviation for Boron Neutron Capture Therapy

SPM-11 is a boron based drug that was developed by Stella Pharma to be utilized in BNCT. As a result of research and development efforts at Stella Chemifa Corporation, the parent company of Stella Pharma, they were able to successfully develop boron isotope enrichment technology to enable the mass production of a boron (Boron 10) compound before its competitors.

SHI has been continuously carrying out research and development in the fields of PET, proton beam therapy cancer treatment systems and other cutting edge cancer medical technologies with a focus on the use of accelerators for over 30 years. This BNCT system is also a result of joint technological development efforts in collaboration with the KURRI and Stella Pharma. Through the conversion of this BNCT system into new medical equipment, SHI continues to contribute towards the expansion of general cutting edge technologies, from cancer diagnosis to treatment, ahead of the world.