XIAMEN, China--(BUSINESS WIRE)--Neuboron Medical Group (NMG), a leading global Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) total solution provider today announced that the first AB-BNCT cancer research center in China, Xiamen Humanity Hospital (XHH) BNCT Center has successfully performed 14 irradiations on 12 patients for its first Investigator Initiated Trial (IIT) aimed to evaluate the safety and efficacy of BNCT in the treatment of advanced refractory malignant tumors. With this milestone, China has become the second country to master and utilize accelerator BNCT technology.
The clinical protocol relied on a full suite of NeuPex AB-BNCT device system and NeuMANTA® Treatment Planning system, boron-containing drug BPA and PET imaging drug F-BPA supplied from Neuboron. NeuPex is a highly integrated and sophisticated medical system that consists of a Beam Shaping Assembly, Accelerator, Patient Positioning System, Dose Monitoring System, QC/QA System, Medical User Control system and Interlocks, etc. Benefiting from Neuboron’s unique beam control technology, the NeuPex system under the proton condition of 18.4 kW/2.3 MeV/8 mA (the highest efficiency of AB-BNCT system in clinical use worldwide) has already met the clinical criteria. The accelerator for the NeuPex system is manufactured by Neuboron’s partner TAE Life Sciences.
This clinical research was launched on Oct. 9, 2022, after being validated by a large number of animal preclinical studies and approved by Xiamen Humanity Hospital’s Institutional Review Board (IRB). These twelve patients were diagnosed with recurrent head and neck, high-grade glioma, and melanoma cancers with traditional cancer therapies exhausted.
After a 3-month follow-up, the first 4 patients showed satisfactory safety and superior tumor control performance. All of them showed tumor regression. The 12 patients will have remained follow-up observation accordingly. The clinical study preliminarily not only verifies the safety of the combined treatment of neutron radiation and BPA drug, but also demonstrated good clinical treatment value.
“The completion of our first-in-human clinical study at this stage demonstrates great efficacy and safety using novel in-hospital accelerator-based BNCT,” said Prof Yuan-Hao Liu, Ph.D., CEO and CSO of Neuboron Medical Group. “This milestone marks a great potential to treat recurrent, advanced, and refractory cancer.” “We are very excited to have witnessed this binary radiotherapy expanding our patient’s lives and will continue to work tirelessly on our end to bring our one-stop BNCT total solution to the global market as quickly as possible,” emphasized Prof. Dr. Liu.