The “Accelerator-Boron Neutron Capture Therapy (A-BNCT)” has entered clinical trials as new anticancer therapy six months after it won approval.

According to the minutes of the Central Pharmaceutical Review Committee made public recently, the developers – Dawon Medax and Gachon University Gil Medical Center – tried hard to establish a system to protect patients and effectively cope with emergencies in the clinical trials of the A-BNCT.

The Ministry of Food and Drug Safety disclosed the minutes on Wednesday.

To treat cancer, boron neutron capture therapy (BNCT) irradiates low-energy neutrons into the body after injecting boron drugs that are harmless to humans.

The boron drug combines boron (10B) and amino acid. It is selectively accumulated in cancer cells more than in normal cells through the L-type Amino Transporter (LAT1), which is often expressed in cancer cells. The accumulated boron absorbs neutrons and undergoes fission to kill cancer cells.

Dawon Medax received approval from the food and drug safety ministry for the phase 1/2a clinical trial of the BNCT therapy in patients with recurrent, high-grade glioma on June 30.

Three medical institutions, including Gil Medical Center, will conduct the clinical trial. However, only one institution – BNCT Clinic in the BRC Center in Songdo, Incheon – will provide treatment because it is where A-BNCT equipment developed by Dawon Medax is installed.

The approval process was not easy.

“It may be necessary for the applicant (BNCT Clinic) to participate in clinical, but it needs to supplement management plans for patient safety,” said the head of the review committee after completing the first meeting. “It should present detailed countermeasures in patient transfers or emergencies by preparing medical equipment and personnel.”

After the first meeting, Dawon Medax submitted supplementary plans by meeting the committee’s requests, and the ministry sought the committee’s advice.

However, the review committee also demanded additional supplementation to the revised plan in the second meeting, calling for more equipment and personnel for patient transfers and coping with emergencies.

The ministry said, “We, along with the applicant, will supplement qualified personnel and equipment at BNCT Clinic with expert advice. The ministry will also conduct thorough follow-up checks.”

After all these twists and turns, Dawon Medax will begin clinical trials at Gil Medical Center this month and continue through April 2024.

“The upcoming clinical trial will target glioblastoma, but we will expand indications to intractable cancers, such as malignant brain tumors, head and neck cancers, and melanoma of the skin,” Dawon Medax said.