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Advanced Medical Science-Planning and Hokkaido University to Collaborate on research for the introduction of Gallium-68 PSMA-11 in Japan

July 1, 2020
(Tokyo, Japan, July 1, 2020) Advanced Medical Science-Planning (AMS), an innovative Japanese nuclear medicine start-up company, announced the establishment of collaborative research with Hokkaido University’s Central Institute of Isotope Science, and the Department of Diagnostic Imaging, Graduate School of Medicine, for the introduction of Gallium-68 PSMA-11 (68Ga-PSMA) in Japan. AMS will also collaborate with the Department of Renal and Genitourinary Surgery, Hokkaido University, to plan and conduct clinical trials, as necessary, at Hokkaido University Medical Hospital.

AMS is presently working in the application process to the Japan Pharmaceutical and Medical Devices Agency (PMDA) on a phased approach to bring 68Ga-PSMA-PET diagnosis for prostate cancer to Japan. This diagnosis capability is currently undergoing regulatory approvals in countries, such as the United States. AMS plans to deploy synthesizers in partnership with Hokkaido university to produce 68Ga-PSMA, which are presently used for clinical trials outside Japan.

Hokkaido University has led the discussion on regulatory and research aspects of 68Ga-PSMA-PET in Japan. Collaborative research between Hokkaido University and AMS will play an indispensable role in demonstrating the licensing basis for 68Ga-PSMA. AMS President Yuichiro Sugawara stated, “AMS deeply appreciates the start of a strategic relationship with Hokkaido University to conduct research associated with a pre-clinical and clinical study on Gallium-68 PSMA 11 to support our application before the PMDA. Japanese prostate cancer patients deserve access to the same diagnostic methods that are under licensing approval and available in Western nations. AMS is at the forefront of providing Japanese patients and the Japanese medical community with new diagnostic options that will enable new treatment options as well.”

Advanced Medical Science-Planning

Pursuant to the corporate mantra “Cure Better, Innovation”, AMS will deploy nuclear medicine based Theranostics, which combines both therapeutic and diagnostic capabilities in one dose for cancer treatment, as well as pairing Theranostics with artificial intelligence to enhance their effectiveness in terms of precision oncology. As the first step in our growth strategy, AMS is engaged in a phased approach to bring 68Ga-PSMA-PET diagnosis for prostate cancer to Japan—a diagnosis tool that is currently available in the United States, Europe, and Australia.

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