TY - JOUR
T1 - Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan
AU - Nagai, Sumimasa
AU - Sugiyama, Daisuke
N1 - Funding Information:
In particular, the Practical Research for Innovative Cancer Control program of the Japan cancer research project and The Translational Research Program; Strategic Promotion for Practical Application of Innovative Medical Technology (TR-SPRINT) of the project of translational and clinical research core centers have funded many clinical trials of gene and cellular therapies for cancer, including the following: oncolytic virus G47 delta (University of Tokyo); hemagglutinating virus of Japan envelope (HVJ-E) (Osaka University); survivin-responsive conditionally replicating adenoviruses regulated with multiple factors (Surv.m-CRA-1; Kagoshima University); NY-ESO-1 TCR T-cell therapy (Nagasaki University and Mie University); aAVC-WT1 therapy (University of Tokyo and Riken); MS3-WT1-siTCR T-cell therapy (Mie University); and CAR T-cell therapy using nonviral vectors (Nagoya University) ( ; as shown, many oncolytic virus therapies and CAR T-cell therapies have been funded. Tables II and III ). In addition, these 2 AMED programs have funded preclinical research projects of gene and cellular therapies for cancer, which are listed in Table IV
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2019/1
Y1 - 2019/1
N2 - Purpose: In Japan, gene therapy and cellular therapy are categorized as regenerative medicine products based on the Pharmaceuticals and Medical Devices Law that was implemented in 2014. In this new law, regenerative medicine products were newly defined, and a conditional and term-limited approval system for regenerative medicine products was instituted. In addition, the Ministry of Health, Labour and Welfare instituted the SAKIGAKE (meaning pioneer or forerunner in Japanese) designation system in 2015. This designation is similar to the breakthrough therapy designation in the United States. These new regulatory frameworks have stimulated clinical development of new gene and cellular products in Japan. In fact, oncolytic virus therapy for glioblastoma and NY-ESO-1 (T-cell receptor) T-cell therapy for synovial sarcoma were granted SAKIGAKE designation in 2016 and 2018, respectively. Oncolytic virus therapy and genetically engineered T-cell therapy for cancer are being actively developed and examined in investigator-initiated trials. Methods: This review analyzes the domestic and international clinical trial registries to comprehensively collect information on clinical trials of gene and cellular therapeutic products for cancer in Japan. Implications: Current trends in clinical development of gene and cellular therapeutic products for cancer in Japan are discussed.
AB - Purpose: In Japan, gene therapy and cellular therapy are categorized as regenerative medicine products based on the Pharmaceuticals and Medical Devices Law that was implemented in 2014. In this new law, regenerative medicine products were newly defined, and a conditional and term-limited approval system for regenerative medicine products was instituted. In addition, the Ministry of Health, Labour and Welfare instituted the SAKIGAKE (meaning pioneer or forerunner in Japanese) designation system in 2015. This designation is similar to the breakthrough therapy designation in the United States. These new regulatory frameworks have stimulated clinical development of new gene and cellular products in Japan. In fact, oncolytic virus therapy for glioblastoma and NY-ESO-1 (T-cell receptor) T-cell therapy for synovial sarcoma were granted SAKIGAKE designation in 2016 and 2018, respectively. Oncolytic virus therapy and genetically engineered T-cell therapy for cancer are being actively developed and examined in investigator-initiated trials. Methods: This review analyzes the domestic and international clinical trial registries to comprehensively collect information on clinical trials of gene and cellular therapeutic products for cancer in Japan. Implications: Current trends in clinical development of gene and cellular therapeutic products for cancer in Japan are discussed.
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U2 - 10.1016/j.clinthera.2018.11.003
DO - 10.1016/j.clinthera.2018.11.003
M3 - Review article
C2 - 30528048
AN - SCOPUS:85057618266
SN - 0149-2918
VL - 41
SP - 174-184.e3
JO - Clinical Therapeutics
JF - Clinical Therapeutics
IS - 1
ER -
