On May 30, 2024 Alpha Fusion Co., Ltd. reported that its joint research partner, a research team led by Lecturer Naofumi Watanabe of the Department of Radiation Medicine at the Graduate School of Medicine, Osaka University, will begin a new physician-initiated clinical trial targeting standard treatment-resistant prostate cancer in June 2024 at the Department of Nuclear Medicine, Osaka University Hospital (Press release, Alpha Fusion, MAY 30, 2024, View Source [SID1234647193]).

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The astatine-labeled drug ([At-211]PSMA-5) used in a new alpha-ray therapy targeting prostate-specific membrane antigen (PSMA) expressed in prostate cancer, developed by Lecturer Watanabe’s research team, has been confirmed to have a long-lasting tumor regression effect after a single administration in a prostate cancer model mouse. Due to its strong effect in model mouse experiments, it is considered to be a particularly promising drug candidate compound.

[At-211]PSMA-5 has been selected for the Japan Agency for Medical Research and Development (AMED) Translational Support Research Program (Seeds F) "Project name: Conducting an investigator-initiated clinical trial for the practical application of an innovative alpha-ray therapy targeting prostate-specific membrane antigen (PSMA)" due to its usefulness, path to practical application, and the collaborative system between Osaka University and Alpha Fusion. Alpha Fusion will contribute to the practical application of this investigational drug as the world’s first prostate cancer treatment using astatine. This investigator-initiated clinical trial

is a phase I clinical trial to confirm the tolerability, safety, pharmacokinetics, and efficacy after administration of [At-211]PSMA-5 to patients with castration-resistant prostate cancer who have difficulty in implementing and continuing standard treatment. This is the first time that this investigational drug will be administered to humans in the world. The design is a dose-escalation design, starting with a low dose as an anticancer drug clinical trial and gradually increasing the dose.

[Study name] Phase I investigator-initiated clinical trial of a new alpha-particle nuclear medicine treatment for patients with castration-resistant prostate cancer.
・Subjects: Patients with castration-resistant prostate cancer for whom standard treatment is difficult to implement or continue
・Investigational drug: PSW-1025 (compound name: [At-211]PSMA-5)
・Period: June 2024 to March 2027 (planned)
・Planned number of cases: 15 cases
・Principal investigator: Naofumi Watanabe (Department of Nuclear Medicine, Osaka University Hospital)