Orphan Drug Designation for Borofalan (10B) (SPM-011) as treatment of Recurrent Malignant Glioma and Recurrent Meningioma
Our product Borofalan (10B) (development code: SPM-011), which we are developing as a boron drug for BNCT (Boron Neutron Capture Therapy) for the treatment of Recurrent Malignant Glioma※1 and Recurrent Meningioma※2, has been designated as orphan drug by the Japanese Ministry of Health, Labour and Welfare (MHLW).
The orphan drug designation requires certain conditions such as a high medical need for treatment of diseases that affect less than 50,000 people in Japan. This system grants preferential treatment such as access to research development subsidies and other benefits.
We are currently developing BNCT for the two mentioned diseases and for recurrent meningioma, the observation period of phase II investor-initiated clinical trial targeting recurrent high-grade meningioma has been concluded. We continue to do our best efforts to provide BNCT as early as possible to patients with these designated diseases.
※１ Malignant glioma
Glioma is a sort of malignant tumor that develops in the brain and comprises approximately 30% of primary brain tumors. According to the malignancy, they are classified into four stages (grade I -IV). Glioma of grades III and IV are called glioblastoma. Malignant glioma including glioblastoma are also today considered as difficult to treat.
※２ Meningioma
Meninges are thin layers of tissue protecting the brain and spinal cord. In the inner side of this inner layers the brain tumor meningioma develops. Most meningiomas are benign (WHO grade I, but the highly malignant (WHO grade II and III) can also infiltrate the brain, cerebral blood vessels and skull, leading to repeated recurrences. Furthermore, they can develop metastasis into the lungs and other organs. Recurrences are treated with surgery or external X-ray irradiation, but several limitations still exists and therefore, there is no effective treatment established yet.
