FOOTHILL RANCH, Calif.– TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), today announced that the first accelerator-based BNCT (AB-BNCT) clinical research center at Xiamen Humanity Hospital (XHH) has now treated 12 patients in its Investigator Initiated Trial (IIT) aimed at evaluating the safety and efficacy of BNCT in the treatment of advanced refractory malignant tumors. Treated with the NeuPex System from Neuboron with TLS’s electrostatic Neutron Beam System (NBS), these are the first human patients treated with AB-BNCT technology outside of Japan.
With traditional cancer therapies exhausted, these twelve patients diagnosed with recurrent head and neck, glioma and melanoma cancers underwent BNCT through permission from Xiamen Hospital’s Institutional Review Board (IRB) validated by a large-scale animal preclinical study. Patients met the BNCT requirements and were evaluated using F18-BPA PET/CT imaging, which measures the accumulation of boron in the tumor. The treatments lasted less than one hour, and interim results are encouraging with evidence of tumor control. Patient treatments under IIT are expected to continue throughout the year.
“The treatment of patients with BNCT at Xiamen Humanity Hospital is a tremendous step forward in the journey to treat invasive, recurrent and difficult-to-treat cancer,” said Bruce Bauer, PhD, CEO of TAE Life Sciences. “We completed installation of our Neutron Beam System in early 2022 during a global pandemic and this milestone underscores the momentum of our collaboration with Neuboron and XHH as we work to establish BNCT as an effective cancer treatment.”
TLS’ Neutron Beam System in the NeuPex System enables a new treatment option for patients diagnosed with the most aggressive and recurrent cancers such as gliomas, head and neck tumors and melanomas. With the ability to deliver more precise, targeted radiation to cancer cells while sparing damage to surrounding healthy tissue, this technique holds a therapeutic potential where previous treatment options have been exhausted or are unavailable.
The clinical protocol utilized the boron-containing drug BPA and PET imaging drug F-BPA supplied by Neuboron. There was no evidence that remarkable adverse events or side effects were found in these first patients after four months, instead, early demonstration is seen of superior tumor control and signs of tumor shrinkage. The clinical study preliminarily verifies the safety of the combined treatment of neutron radiation and BPA drug and demonstrated good clinical treatment value.
The XHH BNCT Center, completed in 2020, is the first BNCT clinical research center operating in China. It is fully designed to safely operate two horizontal beams and one vertical beam using the Neuboron NeuPex AB-BNCT system. The center has 3 simulation rooms in addition to the 3 treatment rooms, allowing for the facilitation of patient positioning work and increasing patient turnover rate.
