Heron Submits TFDA IND Application for Phase II Clinical Trial of B10 L-BPA Drug in Head and Neck Cancer Patients

Heron Neutron Medical Corp. (Heron) announced that it has submitted an Investigational New Drug (IND) application to the Taiwan Food and Drug Administration (TFDA) for the B10 L-BPA drug, intended for a Phase II clinical trial in patients with head and neck cancer. This submission has been officially accepted for review. Boron Neutron Capture Therapy (BNCT) leverages the ability of boron-10 to absorb neutrons and generate two high biological damage particles, which can selectively destroy cancer cells. This B10 L-BPA drug will be evaluated in the Phase II clinical trial to assess safety and therapeutic efficacy in patients with inoperable recurrent head and neck cancer.

 

The study is designed as a non-controlled, single-arm, open-label, non-randomized, superiority clinical trial, ensuring reliable therapeutic and statistical outcomes. Currently, no BNCT drug has been approved by the TFDA for treating inoperable recurrent head and neck cancer in Taiwan.

 

Per regulatory requirements in Taiwan, clinical trial execution may proceed only after approval by both the TFDA and the hospital’s Institutional Review Board (IRB), unless additional documentation or objections are raised by regulatory authorities prior to trial commencement.