Institute of Nuclear Energy Research, Atomic Energy Council, Executive Yuan (aka INER) is dedicated to research and development (R&D) on atomic energy technologies to service the people’s livelihood, and actively involved in the research and application of atomic energy technology in biomedicine. Dolacga, a liver function imaging agent innovated by INER, is the first liver-targeting glycopeptide drug for liver function imaging in the world. INER has obtained the patents of “Hexa-Lactoside-Triazanonane Triacetic acid (NOTA) Derivative, Method for Radiolabelling Hexa-Lactoside Positron Emission Tomography” in countries of Taiwan, Japan and USA.
To maintain enough functional mass of liver is the key for survival of patient. There is statistical difference of asialoglycoprotein receptors on liver parenchymal cell membrane between normal liver and diseased liver; therefore, by asialoglycoprotein receptor imaging technique, we can sensitively to see the imaging difference between normal liver and diseased liver.
Dolacga was used for evaluation of liver reserve has been successfully approved and performed to enroll 12 evaluable subjects (including 7 males and 5 females) for phase I clinical trial for testing the biodistribution, dosimetry and pharmacological safety at National Taiwan University Hospital (NTUH). The results indicated its highly liver-targeting with an average of 0.0098 and 0.027 mSv/MBq in liver and whole body, respectively. The pharmacological safety was confirmed by a series of physical examination including electrocardiogram, life sign, blood, biochemical, and urine laboratory examinations etc. The results showed no statistically difference from the normal baseline, which indicated the safety of this agent. In 2020, Dolacga has applied the FDA phase II clinical trial with titled “An Open-Label, Comparative Phase II Clinical Trial to Assess the Accuracy and Reliability of the Ga-68 Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve among Scheduled Operation Patients”.
INER won 2020 National Invention and Creation Award-Silver Medal Award from Ministry of Economic Affairs by the patent “Hexa-Lactoside-Triazanonane Triacetic acid (NOTA) Derivative, Method for Radiolabelling Hexa-Lactoside Positron Emission Tomography”. The winning rate is only 7.4% that is the lowest over the years. INER will present the invention at 2021 Taiwan Innotech Expo to show these innovatiion achievements.
INER has strong pharmaceutical research teams, and will continuously effort to bring-up domestic medical theranostic level and fullfill the responsibility of domestic health-care in the future.
Fig 1. There is statistical difference of asialoglycoprotein receptors on liver parenchymal cell membrane between normal liver and diseased liver (upper figure). Therefore, by asialoglycoprotein receptor imaging technique, we can sensitively to see the imaging difference between normal liver and diseased liver (bottom figure).
【Contact Information】
Division of Isotope Applications, Institute of Nuclear Energy Research
Director, Dr. Jeng-Jong Wang (O)03-4711400#7000
Dr. Mei-Hui Wang (O)03-4711400#7162