Preclinical Safety Pharmacology Study of a Novel Protein-Based Cancer Vaccine CHP-NY-ESO-1

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概要

• 論文の詳細を見る

• CHP-NY-ESO-1 is a novel therapeutic cancer vaccine consisting of a recombinantprotein of cancer antigen NY-ESO-1 and a polysaccharide-based delivery system,cholesteryl pullulan. A pilot clinical study of CHP-NY-ESO-1 in cancer patients waspreviously conducted, and the adverse events related to this drug were observed to belimited to skin reactions at injection sites. To further establish the safety ofCHP-NY-ESO-1, we studied the effects of its subcutaneous injection on vital functionssuch as the central nervous system, cardiovascular system and respiratory system usingpreclinical animal models. The effects of CHP-NY-ESO-1 on the cardiovascular systemwere investigated in dogs using a telemetry system for blood pressure and heart rateand the Holter monitoring for ambulatory electrocardiograms. No drug-relatedchanges were observed in these parameters. The effect of CHP-NY-ESO-1 on thehERG-dependent potassium currents was also examined using in vitro cultured cellsystem, and no inhibition of hERG currents was observed. The effects ofCHP-NY-ESO-1 on the central nervous system were examined in rats using functionalobservational battery method, and no drug-related changes were observed in homecage observations, open field observations, hand held observations, and perception andmotor function observations. The effect of CHP-NY-ESO-1 on the respiratory systemwas investigated in rats by measuring tidal volume, minute volume and respiratory rateusing whole-body plethysmograph method, and no significant changes were found inthese parameters. These results indicate that CHP-NY-ESO-1 would not have anypharmacological effects on vital functions and support the safety of this cancer vaccinefor clinical use.

• 神戸大学の論文

著者

• Kuno Takayoshi

  Division of Molecular Pharmacology and Pharmacogenomics, Department of Biochemistry and Molecular Bi

• SHIKU Hiroshi

  Department of Hematology and Oncology, Mie University Graduate School of Medicine

• Kuno Takayoshi

  イミュノフロンティア

• Kuno Takayoshi

  Division Of Molecular Pharmacology And Pharmacogenomics Department Of Biochemistry And Molecular Bio

• Kuno Takayoshi

  Division Of Molecular Pharmacology And Pharmacogenomics Kobe University Graduate School Of Medicine

• Kuno Takayoshi

  神戸大学医学研究科

• Shiku Hiroshi

  Department Of Cancer Vaccine Mie University Graduate School Of Medicine

• Harada Naozumi

  Basic and Preclinical Research Department ImmunoFrontier, Inc.,

• Hoshiai Kiyotaka

  Pharmacology department, Kobuchisawa Research Laboratories, Fuji Biomedix Co., Ltd.,

• Takahashi Yoshiyasu

  Pharmacology department, Kobuchisawa Research Laboratories, Fuji Biomedix Co., Ltd.,

• Sakaguchi Yasue

  Pharmacology department, Kobuchisawa Research Laboratories, Fuji Biomedix Co., Ltd.,

• Hishida Tadashi

  Manufacturing Process Development Department, ImmunoFrontier, Inc.,

• Hoshiai Kiyotaka

  Pharmacology Department Kobuchisawa Research Laboratories Fuji Biomedix Co. Ltd.

• Harada Naozumi

  Basic And Preclinical Research Department Immunofrontier Inc.

• Hishida Tadashi

  Manufacturing Process Development Department Immunofrontier Inc.

• Sakaguchi Yasue

  Pharmacology Department Kobuchisawa Research Laboratories Fuji Biomedix Co. Ltd.

• Takahashi Yoshiyasu

  Pharmacology Department Kobuchisawa Research Laboratories Fuji Biomedix Co. Ltd.

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