Heron Submits TFDA Application for Academic Clinical Trial of B10 L-BPA Drug for Malignant Brain Tumor Patients

 Heron Neutron Medical Corp. (Heron) announced today that it has submitted an application to the Taiwan Food and Drug Administration (TFDA) for an investigational new drug (IND) review of the B10 L-BPA drug for academic clinical trials in patients with malignant brain tumors. The B10 L-BPA drug will be evaluated during Phase I and Phase II academic clinical trials to assess its safety and efficacy as a boron carrier in Boron Neutron Capture Therapy (BNCT) for treating malignant brain tumors.

 The study will be conducted as a non-controlled, single-arm, open-label, non-randomized, single-center clinical trial. At present, there is no TFDA-approved BNCT drug for malignant brain tumors in Taiwan. According to domestic regulatory requirements, the clinical trial can only proceed after approval by both the TFDA and the hospital’s Institutional Review Board (IRB).