Application for Orphan Drug Designation: Borofalan (10B) for Recurrent Malignant Glioma and Recurrent Meningioma
Stella Pharma announces that it has applied to the Japanese Ministry of Health, Labour and Welfare (MHLW) for orphan drug designation of Borofalan (10B) (development code: SPM-011), which is being developed as a boron agent for BNCT (Boron Neutron Capture Therapy), for the treatment of recurrent malignant gliomas and recurrent meningiomas.
The orphan drug designation requires a high medical need for serious, life-threatening diseases that affect less than 50,000 people in Japan. To promote research and development of drugs for rare diseases, this system grants subsidies and other benefits.
We continue to develop the BNCT applicability for the above mentioned indications. As for recurrent meningioma, the observation period in Phase II of the investigator-initiated clinical trial targeting recurrent high-grade meningioma has been completed and we strive to obtain an early approval.
※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.
