=== Generating (published_papers) ===
=== Generating (teaching_experience) ===
=== Generating (misc) ===
=== Generating (research_projects) ===
=== Generating (awards) ===
=== Generating (presentations) ===
==== begin registerFile(/WWW/pub2/data/ERD/person/396628/researchmap/published_papers.jsonl) ====
line:1, {"insert":{"user_id":"R000060105","type":"published_papers","id":"48169707"},"force":{"see_also":[{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=414762","label":"url"}],"paper_title":{"en":"A Stealthiness Evaluation of Main Chain Carboxybetaine Polymer Modified into Liposome","ja":"A Stealthiness Evaluation of Main Chain Carboxybetaine Polymer Modified into Liposome"},"authors":{"en":[{"name":"Najmina Mazaya"},{"name":"Kobayashi Shingo"},{"name":"Shimazui Rena"},{"name":"Takata Haruka"},{"name":"Shibata Mayuka"},{"name":"Ishibashi Kenta"},{"name":"Kamizawa Hiroshi"},{"name":"Kishimura Akihiro"},{"name":"Shiota Yoshihito"},{"name":"Ida Daichi"},{"name":"Shimizu Taro"},{"name":"Ishida Tatsuhiro"},{"name":"Katayama Yoshiki"},{"name":"Tanaka Masaru"},{"name":"Mori Takeshi"}],"ja":[{"name":"Najmina Mazaya"},{"name":"小林 慎吾"},{"name":"Shimazui Rena"},{"name":"髙田 春風"},{"name":"Shibata Mayuka"},{"name":"Ishibashi Kenta"},{"name":"Kamizawa Hiroshi"},{"name":"Kishimura Akihiro"},{"name":"Shiota Yoshihito"},{"name":"Ida Daichi"},{"name":"清水 太郎"},{"name":"石田 竜弘"},{"name":"Katayama Yoshiki"},{"name":"Tanaka Masaru"},{"name":"森 健"}]},"publication_date":"2024-09-28","publication_name":{"en":"Pharmaceutics","ja":"Pharmaceutics"},"volume":"Vol.16","number":"No.10","starting_page":"1271","ending_page":"1271","languages":["eng"],"referee":true,"identifiers":{"doi":["10.3390/pharmaceutics16101271"],"issn":["1999-4923"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:2, {"insert":{"user_id":"R000060105","type":"published_papers","id":"45763826"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/38273445","label":"url"},{"@id":"https://cir.nii.ac.jp/crid/1360301163936245376/","label":"url"},{"@id":"https://www.scopus.com/record/display.url?eid=2-s2.0-85184304070&origin=inward","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=405318","label":"url"}],"paper_title":{"en":"Impact of anti-PEG IgM induced via the topical application of a cosmetic product containing PEG derivatives on the antitumor effects of PEGylated liposomal antitumor drug formulations in mice","ja":"Impact of anti-PEG IgM induced via the topical application of a cosmetic product containing PEG derivatives on the antitumor effects of PEGylated liposomal antitumor drug formulations in mice"},"authors":{"en":[{"name":"Sherif A Gaballa"},{"name":"Shimizu Taro"},{"name":"Takata Haruka"},{"name":"ANDO Hidenori"},{"name":"Mohamed Ibrahim"},{"name":"Sherif Emam Abdallah Emam"},{"name":"Matsuo Amorim Cristina Nana"},{"name":"Kim Yuri"},{"name":"Youssef W Naguib"},{"name":"Fatma M Mady"},{"name":"Khaled A Khaled"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"Sherif A Gaballa"},{"name":"清水 太郎"},{"name":"髙田 春風"},{"name":"安藤 英紀"},{"name":"Mohamed Ibrahim"},{"name":"Sherif Emam Abdallah Emam"},{"name":"松尾 アモリムクリスティーナ菜々"},{"name":"金 侑里"},{"name":"Youssef W Naguib"},{"name":"Fatma M Mady"},{"name":"Khaled A Khaled"},{"name":"石田 竜弘"}]},"description":{"en":"Poly(ethylene glycol) (PEG) is used in many common products, such as cosmetics. PEG, however, is also used to covalently conjugate drug molecules, proteins, or nanocarriers, which is termed PEGylation, to serve as a shield against the natural immune system of the human body. Repeated administration of some PEGylated products, however, is known to induce anti-PEG antibodies. In addition, preexisting anti-PEG antibodies are now being detected in healthy individuals who have never received PEGylated therapeutics. Both treatment-induced and preexisting anti-PEG antibodies alter the pharmacokinetic properties, which can result in a subsequent reduction in the therapeutic efficacy of administered PEGylated therapeutics through the so-called accelerated blood clearance (ABC) phenomenon. Moreover, these anti-PEG antibodies are widely reported to be related to severe hypersensitivity reactions following the administration of PEGylated therapeutics, including COVID-19 vaccines. We recently reported that the topical application of a cosmetic product containing PEG derivatives induced anti-PEG immunoglobulin M (IgM) in a mouse model. Our finding indicates that the PEG derivatives in cosmetic products could be a major cause of the preexistence of anti-PEG antibodies in healthy individuals. In this study, therefore, the pharmacokinetics and therapeutic effects of Doxil (doxorubicin hydrochloride-loaded PEGylated liposomes) and oxaliplatin-loaded PEGylated liposomes (Liposomal l-OHP) were studied in mice. The anti-PEG IgM antibodies induced by the topical application of cosmetic products obviously accelerated the blood clearance of both PEGylated liposomal formulations. Moreover, in C26 tumor-bearing mice, the tumor growth suppressive effects of both Doxil and Liposomal l-OHP were significantly attenuated in the presence of anti-PEG IgM antibodies induced by the topical application of cosmetic products. These results confirm that the topical application of a cosmetic product containing PEG derivatives could produce preexisting anti-PEG antibodies that then affect the therapeutic efficacy of subsequent doses of PEGylated therapeutics.","ja":"Poly(ethylene glycol) (PEG) is used in many common products, such as cosmetics. PEG, however, is also used to covalently conjugate drug molecules, proteins, or nanocarriers, which is termed PEGylation, to serve as a shield against the natural immune system of the human body. Repeated administration of some PEGylated products, however, is known to induce anti-PEG antibodies. In addition, preexisting anti-PEG antibodies are now being detected in healthy individuals who have never received PEGylated therapeutics. Both treatment-induced and preexisting anti-PEG antibodies alter the pharmacokinetic properties, which can result in a subsequent reduction in the therapeutic efficacy of administered PEGylated therapeutics through the so-called accelerated blood clearance (ABC) phenomenon. Moreover, these anti-PEG antibodies are widely reported to be related to severe hypersensitivity reactions following the administration of PEGylated therapeutics, including COVID-19 vaccines. We recently reported that the topical application of a cosmetic product containing PEG derivatives induced anti-PEG immunoglobulin M (IgM) in a mouse model. Our finding indicates that the PEG derivatives in cosmetic products could be a major cause of the preexistence of anti-PEG antibodies in healthy individuals. In this study, therefore, the pharmacokinetics and therapeutic effects of Doxil (doxorubicin hydrochloride-loaded PEGylated liposomes) and oxaliplatin-loaded PEGylated liposomes (Liposomal l-OHP) were studied in mice. The anti-PEG IgM antibodies induced by the topical application of cosmetic products obviously accelerated the blood clearance of both PEGylated liposomal formulations. Moreover, in C26 tumor-bearing mice, the tumor growth suppressive effects of both Doxil and Liposomal l-OHP were significantly attenuated in the presence of anti-PEG IgM antibodies induced by the topical application of cosmetic products. These results confirm that the topical application of a cosmetic product containing PEG derivatives could produce preexisting anti-PEG antibodies that then affect the therapeutic efficacy of subsequent doses of PEGylated therapeutics."},"publication_date":"2024-02-05","publication_name":{"en":"Molecular Pharmaceutics","ja":"Molecular Pharmaceutics"},"volume":"Vol.21","number":"No.2","starting_page":"622","ending_page":"632","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1021/acs.molpharmaceut.3c00774"],"issn":["1543-8384"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:3, {"insert":{"user_id":"R000060105","type":"published_papers","id":"45763827"},"force":{"see_also":[{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=405320","label":"url"}],"paper_title":{"en":"Peritoneal B Cells Play a Role in The Production of Anti-Polyethylene Glycol (PEG) IgM Against Intravenously Injected siRNA-PEGylated Liposome Complexes","ja":"Peritoneal B Cells Play a Role in The Production of Anti-Polyethylene Glycol (PEG) IgM Against Intravenously Injected siRNA-PEGylated Liposome Complexes"},"authors":{"en":[{"name":"Shimizu Taro"},{"name":"Amr S Abu Lila"},{"name":"Kitayama Yuka"},{"name":"Abe Ryo"},{"name":"Takata Haruka"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"清水 太郎"},{"name":"Amr S Abu Lila"},{"name":"北山 由佳"},{"name":"阿部 遼"},{"name":"髙田 春風"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"publication_date":"2024-02","publication_name":{"en":"Biological & Pharmaceutical Bulletin","ja":"Biological & Pharmaceutical Bulletin"},"volume":"Vol.47","number":"No.2","starting_page":"469","ending_page":"477","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1248/bpb.b23-00733"],"issn":["1347-5215"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:4, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910330"},"force":{"see_also":[{"@id":"http://id.ndl.go.jp/bib/033181684","label":"url"},{"@id":"https://cir.nii.ac.jp/crid/1390579686915245568/","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=403534","label":"url"}],"paper_title":{"en":"マクロゴール4000の関連する全身性紅斑を呈した女児例","ja":"マクロゴール4000の関連する全身性紅斑を呈した女児例"},"authors":{"en":[{"name":"横山 宏司"},{"name":"儘田 光和"},{"name":"Takata Haruka"},{"name":"Shimizu Taro"},{"name":"ANDO Hidenori"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"横山 宏司"},{"name":"儘田 光和"},{"name":"髙田 春風"},{"name":"清水 太郎"},{"name":"安藤 英紀"},{"name":"石田 竜弘"}]},"publication_date":"2023-11-01","publication_name":{"en":"Pediatrics of Japan","ja":"小児科"},"volume":"Vol.64","number":"No.11","starting_page":"1196","ending_page":"1199","languages":["jpn"],"referee":true,"identifiers":{"doi":["10.18888/sh.0000002763"],"issn":["0037-4121"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:5, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910329"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/37355210","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=402792","label":"url"}],"paper_title":{"en":"Anti-PEG IgM production induced by PEGylated liposomes as a function of administration route","ja":"Anti-PEG IgM production induced by PEGylated liposomes as a function of administration route"},"authors":{"en":[{"name":"Takata Haruka"},{"name":"Shimizu Taro"},{"name":"Yamade Rina"},{"name":"Elhewan Ali Emam Elsadek Emam Nehal"},{"name":"Emam Abdallah Emam Sherif"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"髙田 春風"},{"name":"清水 太郎"},{"name":"山出 莉奈"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Sherif Emam Abdallah Emam"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"description":{"en":"Modifying the surface of nanoparticles with polyethylene glycol (PEG) is a commonly used approach for improving the in vitro stability of nanoparticles such as liposomes and increasing their circulation half-lives. We have demonstrated that, in certain conditions, an intravenous (i.v.) injection of PEGylated liposomes (PEG-Lip) induced anti-PEG IgM antibodies, which led to rapid clearance of second doses in mice. SARS-CoV-2 vaccines, composed of mRNA-containing PEGylated lipid nanoparticles, have been widely administered as intramuscular (i.m.) injections, so it is important to determine if PEGylated formulations can induce anti-PEG antibodies. If the favorable properties that PEGylation imparts to therapeutic nanoparticles are to be widely applicable this should apply to various routes of administration. However, there are few reports on the effect of different administration routes on the in vivo production of anti-PEG IgM. In this study, we investigated anti-PEG IgM production in mice following i.m., intraperitoneal (i.p.) and subcutaneous (s.c.) administration of PEG-Lip. PEG-Lip appeared to induce anti-PEG IgM by all the tested routes of administration, although the lipid dose causing maximum responses varied. Splenectomy attenuated the anti-PEG IgM production for all routes of administration, suggesting that splenic immune cells may have contributed to anti-PEG IgM production. Interestingly, in vitro experiments indicated that not only splenic cells but also cells in the peritoneal cavity induced anti-PEG IgM following incubation with PEG-Lip. These observations confirm previous experiments that have shown that measurable amounts of PEG-Lip administered i.p., i.m. or s.c. are absorbed to some extent into the blood circulation, where they can be distributed to the spleen and/or peritoneal cavity, and are recognized by B cells, triggering anti-PEG IgM production. The results obtained in this study have important implications for developing efficient PEGylated nanoparticular delivery system.","ja":"Modifying the surface of nanoparticles with polyethylene glycol (PEG) is a commonly used approach for improving the in vitro stability of nanoparticles such as liposomes and increasing their circulation half-lives. We have demonstrated that, in certain conditions, an intravenous (i.v.) injection of PEGylated liposomes (PEG-Lip) induced anti-PEG IgM antibodies, which led to rapid clearance of second doses in mice. SARS-CoV-2 vaccines, composed of mRNA-containing PEGylated lipid nanoparticles, have been widely administered as intramuscular (i.m.) injections, so it is important to determine if PEGylated formulations can induce anti-PEG antibodies. If the favorable properties that PEGylation imparts to therapeutic nanoparticles are to be widely applicable this should apply to various routes of administration. However, there are few reports on the effect of different administration routes on the in vivo production of anti-PEG IgM. In this study, we investigated anti-PEG IgM production in mice following i.m., intraperitoneal (i.p.) and subcutaneous (s.c.) administration of PEG-Lip. PEG-Lip appeared to induce anti-PEG IgM by all the tested routes of administration, although the lipid dose causing maximum responses varied. Splenectomy attenuated the anti-PEG IgM production for all routes of administration, suggesting that splenic immune cells may have contributed to anti-PEG IgM production. Interestingly, in vitro experiments indicated that not only splenic cells but also cells in the peritoneal cavity induced anti-PEG IgM following incubation with PEG-Lip. These observations confirm previous experiments that have shown that measurable amounts of PEG-Lip administered i.p., i.m. or s.c. are absorbed to some extent into the blood circulation, where they can be distributed to the spleen and/or peritoneal cavity, and are recognized by B cells, triggering anti-PEG IgM production. The results obtained in this study have important implications for developing efficient PEGylated nanoparticular delivery system."},"publication_date":"2023-08","publication_name":{"en":"Journal of Controlled Release","ja":"Journal of Controlled Release"},"volume":"Vol.360","starting_page":"285","ending_page":"292","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1016/j.jconrel.2023.06.027"],"issn":["1873-4995"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:6, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910331"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/33957196","label":"url"},{"@id":"https://www.scopus.com/record/display.url?eid=2-s2.0-85105280797&origin=inward","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=375385","label":"url"}],"paper_title":{"en":"Anti-PEG IgM production and accelerated blood clearance phenomenon after the administration of PEGylated exosomes in mice","ja":"Anti-PEG IgM production and accelerated blood clearance phenomenon after the administration of PEGylated exosomes in mice"},"authors":{"en":[{"name":"Sherif Emam Abdallah Emam"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"Takata Haruka"},{"name":"Kawaguchi Yoshino"},{"name":"Shimizu Taro"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"Sherif Emam Abdallah Emam"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"髙田 春風"},{"name":"川口 桂乃"},{"name":"清水 太郎"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"description":{"en":"Recently, there is an increasing interest in exosomes or extracellular vesicles as potential candidates for delivering RNAs, proteins, genes, and anticancer agents. Engineering of exosome properties is rapidly evolving as a means of expanding exosome applications. PEGylation of exosomes is a technique used to improve their in vivo stability, circulation half-lives, and sometimes to allow the binding targeting ligands to the exosome exterior. According to FDA guidelines for the development of PEGylated proteins, immunological responses to PEGylated molecules and particles should be examined. In this study, we prepared PEGylated exosomes and investigated the production of anti-PEG IgM antibodies after single i.v. injections in mice. In addition, we monitored blood concentrations and tumor accumulation of a second dose of PEGylated exosomes administered after the initial dose. Single injections of PEGylated exosomes in mice induced anti-PEG IgM production in a T cell-dependent manner. The anti-PEG IgM production decreased when the injection dose of PEGylated exosomes was further increased. Anti-PEG IgM induced by injection of PEGylated exosomes decreased blood concentrations of a second dose of PEGylated exosomes and suppressed their tumor accumulation in a C26 murine colorectal cancer model. Initial injection doses of either PEGylated liposomes or PEGylated ovalbumin (PEG-OVA), both of them induced anti-PEG IgM production, also decreased the blood concentration of PEGylated exosomes. Interestingly, anti-PEG IgM induced by injection of PEGylated exosomes did not affect the blood concentration of PEG-OVA. These results imply the importance of monitoring anti-PEG IgM when repeat PEGylated exosome doses are required and/or when PEGylated exosomes are used together with other PEGylated therapeutics.","ja":"Recently, there is an increasing interest in exosomes or extracellular vesicles as potential candidates for delivering RNAs, proteins, genes, and anticancer agents. Engineering of exosome properties is rapidly evolving as a means of expanding exosome applications. PEGylation of exosomes is a technique used to improve their in vivo stability, circulation half-lives, and sometimes to allow the binding targeting ligands to the exosome exterior. According to FDA guidelines for the development of PEGylated proteins, immunological responses to PEGylated molecules and particles should be examined. In this study, we prepared PEGylated exosomes and investigated the production of anti-PEG IgM antibodies after single i.v. injections in mice. In addition, we monitored blood concentrations and tumor accumulation of a second dose of PEGylated exosomes administered after the initial dose. Single injections of PEGylated exosomes in mice induced anti-PEG IgM production in a T cell-dependent manner. The anti-PEG IgM production decreased when the injection dose of PEGylated exosomes was further increased. Anti-PEG IgM induced by injection of PEGylated exosomes decreased blood concentrations of a second dose of PEGylated exosomes and suppressed their tumor accumulation in a C26 murine colorectal cancer model. Initial injection doses of either PEGylated liposomes or PEGylated ovalbumin (PEG-OVA), both of them induced anti-PEG IgM production, also decreased the blood concentration of PEGylated exosomes. Interestingly, anti-PEG IgM induced by injection of PEGylated exosomes did not affect the blood concentration of PEG-OVA. These results imply the importance of monitoring anti-PEG IgM when repeat PEGylated exosome doses are required and/or when PEGylated exosomes are used together with other PEGylated therapeutics."},"publication_date":"2021-06-10","publication_name":{"en":"Journal of Controlled Release","ja":"Journal of Controlled Release"},"volume":"Vol.334","starting_page":"327","ending_page":"334","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1016/j.jconrel.2021.05.001"],"issn":["1873-4995"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:7, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910332"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/33896187","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=374835","label":"url"}],"paper_title":{"en":"Incorporating gangliosides into PEGylated cationic liposomes that complexed DNA attenuates anti-PEG antibody production, but not anti-DNA antibody production in mice","ja":"Incorporating gangliosides into PEGylated cationic liposomes that complexed DNA attenuates anti-PEG antibody production, but not anti-DNA antibody production in mice"},"authors":{"en":[{"name":"Milad Reda Qelliny"},{"name":"Shimizu Taro"},{"name":"Elhewan Ali Emam Elsadek Emam Nehal"},{"name":"Emam Abdallah Emam Sherif"},{"name":"Takata Haruka"},{"name":"Zeinab M. A. Fathalla"},{"name":"Amal K. Hussein"},{"name":"Khaled A. Khaled"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"Milad Reda Qelliny"},{"name":"清水 太郎"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Sherif Emam Abdallah Emam"},{"name":"髙田 春風"},{"name":"Zeinab M. A. Fathalla"},{"name":"Amal K. Hussein"},{"name":"Khaled A. Khaled"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"description":{"en":"Gangliosides (glycosphingolipids) reduce antibody production by inhibiting B-cell receptor (BCR) signaling. We have shown that a copresentation of gangliosides and polyethylene glycol (PEG) on the same liposomes suppresses anti-PEG IgM production in mice. In addition, we recently observed that pDNA incorporated in PEGylated cationic liposomes (PCLs) induces anti-DNA IgM, which could be a hurdle to the development of efficient gene delivery systems. Therefore, the focus of this study was to determine if the copresentation of gangliosides and DNA on the same PCL would suppress antibody production against DNA. PCLs including DNA induced both anti-PEG IgM production and anti-DNA IgM production. The extent of anti-PEG and anti-DNA IgM production was likely dependent on the immunogenicity of the complexed DNA. Treatment of clodronate-containing liposomes, which causes a depletion of phagocytic cells, suppressed anti-PEG IgM production from PCLs that did not include DNA but failed to suppress anti-PEG IgM production from PCLs that complexed DNA (PCLD). Both anti-PEG IgM and anti-DNA IgM was induced in T-cell-deficient nude mice as well as in normal mice following treatment with PCLs and PCLD, respectively. These results indicate that phagocytic cells contribute to anti-PEG IgM production but not to anti-DNA IgM production, while T-cells do not contribute to any form of antibody production. The copresentation of gangliosides and DNA significantly reduced anti-PEG IgM production but unfortunately did not reduce anti-DNA IgM production. It appears that the immunosuppressive effect of gangliosides, presumably via the CD22 signaling pathway, is limited only to anti-PEG immunity.","ja":"Gangliosides (glycosphingolipids) reduce antibody production by inhibiting B-cell receptor (BCR) signaling. We have shown that a copresentation of gangliosides and polyethylene glycol (PEG) on the same liposomes suppresses anti-PEG IgM production in mice. In addition, we recently observed that pDNA incorporated in PEGylated cationic liposomes (PCLs) induces anti-DNA IgM, which could be a hurdle to the development of efficient gene delivery systems. Therefore, the focus of this study was to determine if the copresentation of gangliosides and DNA on the same PCL would suppress antibody production against DNA. PCLs including DNA induced both anti-PEG IgM production and anti-DNA IgM production. The extent of anti-PEG and anti-DNA IgM production was likely dependent on the immunogenicity of the complexed DNA. Treatment of clodronate-containing liposomes, which causes a depletion of phagocytic cells, suppressed anti-PEG IgM production from PCLs that did not include DNA but failed to suppress anti-PEG IgM production from PCLs that complexed DNA (PCLD). Both anti-PEG IgM and anti-DNA IgM was induced in T-cell-deficient nude mice as well as in normal mice following treatment with PCLs and PCLD, respectively. These results indicate that phagocytic cells contribute to anti-PEG IgM production but not to anti-DNA IgM production, while T-cells do not contribute to any form of antibody production. The copresentation of gangliosides and DNA significantly reduced anti-PEG IgM production but unfortunately did not reduce anti-DNA IgM production. It appears that the immunosuppressive effect of gangliosides, presumably via the CD22 signaling pathway, is limited only to anti-PEG immunity."},"publication_date":"2021-06-07","publication_name":{"en":"Molecular Pharmaceutics","ja":"Molecular Pharmaceutics"},"volume":"Vol.18","number":"No.6","starting_page":"2406","ending_page":"2415","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1021/acs.molpharmaceut.1c00255"],"issn":["1543-8384"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:8, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910333"},"force":{"see_also":[{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=374431","label":"url"}],"paper_title":{"en":"Nucleic acids delivered by PEGylated cationic liposomes in systemic lupus erythematosus-prone mice: a possible exacerbation of lupus nephritis in the presence of pre-existing anti-nucleic acid antibodies","ja":"Nucleic acids delivered by PEGylated cationic liposomes in systemic lupus erythematosus-prone mice: a possible exacerbation of lupus nephritis in the presence of pre-existing anti-nucleic acid antibodies"},"authors":{"en":[{"name":"Takata Haruka"},{"name":"Shimizu Taro"},{"name":"Kawaguchi Yoshino"},{"name":"Ueda Hiro"},{"name":"Elhewan Ali Emam Elsadek Emam Nehal"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"髙田 春風"},{"name":"清水 太郎"},{"name":"川口 桂乃"},{"name":"上田 大"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"publication_date":"2021-05-15","publication_name":{"en":"International Journal of Pharmaceutics","ja":"International Journal of Pharmaceutics"},"volume":"Vol.601","starting_page":"120529","ending_page":"120529","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1016/j.ijpharm.2021.120529"],"issn":["0378-5173"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:9, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910334"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/32519877","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=366420","label":"url"}],"paper_title":{"en":"Impact of pre-existing or induced anti-PEG IgM on the pharmacokinetics of peginterferon alfa-2a (Pegasys®) in mice","ja":"Impact of pre-existing or induced anti-PEG IgM on the pharmacokinetics of peginterferon alfa-2a (Pegasys®) in mice"},"authors":{"en":[{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Hondoh Eri"},{"name":"Shimizu Taro"},{"name":"Takata Haruka"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"Sherif Emam Abdallah Emam"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"本藤 栄里"},{"name":"清水 太郎"},{"name":"髙田 春風"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"Sherif Emam Abdallah Emam"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"description":{"en":"PEGylation had been used successfully to improve the circulation half-lives and some physicochemical properties of protein therapeutics. However, anti-polyethylene glycol (anti-PEG) antibodies, either pre-existing or treatment-induced, can negatively affect the pharmacokinetics and pharmacological efficacy of PEGylated proteins. We have examined anti-PEG immune responses in mice for peginterferon alfa-2a (Pegasys), a clinically approved PEGylated protein therapeutic, at both the recommended dose (equivalent to 3 μg/kg in mice) and at higher doses (150 μg/kg) for single or repeated subcutaneous (s.c.) administrations. The effect of treatment-induced anti-PEG IgM on serum concentrations of Pegasys, following repeated administrations, was evaluated. In addition, the effect of pre-existing anti-PEG IgM elicited by a different PEGylated protein, PEG-OVA, on the systemic clearance of Pegasys, was investigated. At a s.c. dose of 3 μg/kg, single injections of Pegasys barely elicited anti-PEG immune responses. Four repeated doses of 150 μg/kg Pegasys elicited anti-PEG IgM production, depending on dose frequency, and triggered the rapid clearance of subsequent doses. In addition, anti-PEG-IgM produced in response to prior administration of PEG-OVA caused a rapid blood clearance of Pegasys. Our results, therefore, underscore the importance of screening for both pre-existing and treatment-induced anti-PEG antibodies in patients prior to and during treatment with PEGylated protein drugs.","ja":"PEGylation had been used successfully to improve the circulation half-lives and some physicochemical properties of protein therapeutics. However, anti-polyethylene glycol (anti-PEG) antibodies, either pre-existing or treatment-induced, can negatively affect the pharmacokinetics and pharmacological efficacy of PEGylated proteins. We have examined anti-PEG immune responses in mice for peginterferon alfa-2a (Pegasys), a clinically approved PEGylated protein therapeutic, at both the recommended dose (equivalent to 3 μg/kg in mice) and at higher doses (150 μg/kg) for single or repeated subcutaneous (s.c.) administrations. The effect of treatment-induced anti-PEG IgM on serum concentrations of Pegasys, following repeated administrations, was evaluated. In addition, the effect of pre-existing anti-PEG IgM elicited by a different PEGylated protein, PEG-OVA, on the systemic clearance of Pegasys, was investigated. At a s.c. dose of 3 μg/kg, single injections of Pegasys barely elicited anti-PEG immune responses. Four repeated doses of 150 μg/kg Pegasys elicited anti-PEG IgM production, depending on dose frequency, and triggered the rapid clearance of subsequent doses. In addition, anti-PEG-IgM produced in response to prior administration of PEG-OVA caused a rapid blood clearance of Pegasys. Our results, therefore, underscore the importance of screening for both pre-existing and treatment-induced anti-PEG antibodies in patients prior to and during treatment with PEGylated protein drugs."},"publication_date":"2020-08-03","publication_name":{"en":"Molecular Pharmaceutics","ja":"Molecular Pharmaceutics"},"volume":"Vol.17","number":"No.8","starting_page":"2964","ending_page":"2970","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1021/acs.molpharmaceut.0c00366"],"issn":["1543-8392"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:10, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910335"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/32278827","label":"url"},{"@id":"https://www.scopus.com/record/display.url?eid=2-s2.0-85083399688&origin=inward","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=364762","label":"url"}],"paper_title":{"en":"Hepatosplenic phagocytic cells indirectly contribute to anti-PEG IgM production in the accelerated blood clearance (ABC) phenomenon against PEGylated liposomes: Appearance of an unexplained mechanism in the ABC phenomenon","ja":"Hepatosplenic phagocytic cells indirectly contribute to anti-PEG IgM production in the accelerated blood clearance (ABC) phenomenon against PEGylated liposomes: Appearance of an unexplained mechanism in the ABC phenomenon"},"authors":{"en":[{"name":"El Sayed M M"},{"name":"Takata Haruka"},{"name":"Shimizu Taro"},{"name":"Kawaguchi Yoshino"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Alaaeldin E"},{"name":"Ishima Yu"},{"name":"ANDO Hidenori"},{"name":"Kamal A"},{"name":"Sarhan H A"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"El Sayed M M"},{"name":"髙田 春風"},{"name":"清水 太郎"},{"name":"川口 桂乃"},{"name":"Amr Selim Ahmed Ali Abu Lila"},{"name":"Nehal Emam Elsadek Emam Ali Elhewan"},{"name":"Alaaeldin E"},{"name":"異島 優"},{"name":"安藤 英紀"},{"name":"Kamal A"},{"name":"Sarhan H A"},{"name":"石田 竜弘"}]},"description":{"en":"The accelerated blood clearance (ABC) phenomenon, caused in large degree via in vivo anti-PEG IgM production, is one of obstacles for development of PEGylated liposome and protein formulations, due to decreased efficiency and/or side effects such as anaphylaxis upon repeat administrations. We have shown in murine ABC models that splenectomy suppressed the level of anti-PEG IgM production induced by PEGylated liposomes, indicating that murine splenic B cells play an important role in its production. However, splenectomy did not completely inhibit production of anti-PEG IgM, suggesting that other cells may contribute to its production in the ABC phenomenon. In this study, we examined the contribution of hepatosplenic phagocytic cells to anti-PEG IgM production and clearance of PEGylated liposomes during the ABC phenomenon. Depletion of hepatosplenic phagocytic cells by pretreatment of mice with clodronate-containing non-PEGylated liposomes suppressed anti-PEG IgM production to a considerable degree, without a change in the number of splenic B cells, and attenuated the enhanced clearance of second dose of PEGylated liposomes. These results suggest that hepatosplenic phagocytic cells, in addition to splenic B cells, contribute to the production of anti-PEG IgM and the ABC phenomenon against PEGylated liposomes. The mechanism whereby splenic B cells interact with hepatosplenic phagocytic cells to produce anti-PEG IgM, upon administration of an initial dose of PEGylated liposomes remains to be elucidated.","ja":"The accelerated blood clearance (ABC) phenomenon, caused in large degree via in vivo anti-PEG IgM production, is one of obstacles for development of PEGylated liposome and protein formulations, due to decreased efficiency and/or side effects such as anaphylaxis upon repeat administrations. We have shown in murine ABC models that splenectomy suppressed the level of anti-PEG IgM production induced by PEGylated liposomes, indicating that murine splenic B cells play an important role in its production. However, splenectomy did not completely inhibit production of anti-PEG IgM, suggesting that other cells may contribute to its production in the ABC phenomenon. In this study, we examined the contribution of hepatosplenic phagocytic cells to anti-PEG IgM production and clearance of PEGylated liposomes during the ABC phenomenon. Depletion of hepatosplenic phagocytic cells by pretreatment of mice with clodronate-containing non-PEGylated liposomes suppressed anti-PEG IgM production to a considerable degree, without a change in the number of splenic B cells, and attenuated the enhanced clearance of second dose of PEGylated liposomes. These results suggest that hepatosplenic phagocytic cells, in addition to splenic B cells, contribute to the production of anti-PEG IgM and the ABC phenomenon against PEGylated liposomes. The mechanism whereby splenic B cells interact with hepatosplenic phagocytic cells to produce anti-PEG IgM, upon administration of an initial dose of PEGylated liposomes remains to be elucidated."},"publication_date":"2020-07-10","publication_name":{"en":"Journal of Controlled Release","ja":"Journal of Controlled Release"},"volume":"Vol.323","starting_page":"102","ending_page":"109","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1016/j.jconrel.2020.04.011"],"issn":["1873-4995"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
line:11, {"insert":{"user_id":"R000060105","type":"published_papers","id":"43910336"},"force":{"see_also":[{"@id":"https://www.ncbi.nlm.nih.gov/pubmed/32376372","label":"url"},{"@id":"https://web.db.tokushima-u.ac.jp/cgi-bin/edb_browse?EID=365548","label":"url"}],"paper_title":{"en":"Pegfilgrastim (PEG-G-CSF) induces anti-PEG IgM in a dose dependent manner and causes the accelerated blood clearance (ABC) phenomenon upon repeated administration in mice","ja":"Pegfilgrastim (PEG-G-CSF) induces anti-PEG IgM in a dose dependent manner and causes the accelerated blood clearance (ABC) phenomenon upon repeated administration in mice"},"authors":{"en":[{"name":"Elhewan Ali Emam Elsadek Emam Nehal"},{"name":"Lila Abu Ali Ahmed Selim Amr"},{"name":"Emam Abdallah Emam Sherif"},{"name":"Shimizu Taro"},{"name":"Takata Haruka"},{"name":"ANDO Hidenori"},{"name":"Ishima Yu"},{"name":"Ishida Tatsuhiro"}],"ja":[{"name":"Elhewan Ali Emam Elsadek Emam Nehal"},{"name":"Lila Abu Ali Ahmed Selim Amr"},{"name":"Emam Abdallah Emam Sherif"},{"name":"清水 太郎"},{"name":"髙田 春風"},{"name":"安藤 英紀"},{"name":"異島 優"},{"name":"石田 竜弘"}]},"description":{"en":"Pegfilgrastimis a recombinant PEGylated human granulocyte colony-stimulating factor (G-CSF) analog filgrastim (trade names Neulasta® or G-Lasta®) that stimulates the production of white blood cells (neutrophils). It is employed as an alternative to filgrastim (G-CSF) for chemotherapy-induced neutropenia in patients due to its longer half-life. In clinical settings, PEG-G-CSF is administered to cancer patients via both the s.c. and i.v. routes. In a murine study, we showed that, regardless of administration route, initial doses of PEG-G-CSF above 0.06 mg/kg elicited anti-PEG immune response in a dose-dependent manner. I.v. administration elicited higher levels of anti-PEG IgM than the s.c. route. Initial doses of PEG-G-CSF (6 mg/kg) that were high enough to trigger production of anti-PEG IgM, did not trigger the accelerated clearance of a lower subsequent dose (0.06 mg/kg) that was similar to i.v. clinical doses of PEG-G-CSF, but when the subsequent dose of PEG-G-CSF was raised to (6 mg/kg), the initial dose triggered the accelerated clearance of the second dose via an anti-PEG IgM-mediated complement activation. Similar observations were noted when an increased PEG-OVA dose was given as the second dose, indicating that pre-existing and/or treatment-induced anti-PEG antibodies might compromise the therapeutic activity and/or reduce tolerance of other PEGylated formulations. To the best of our knowledge, this is the first report to suggest the induction of the ABC phenomenon upon repeated injections of pegfilgrastim. In the clinic, cancer patients, receiving multiple cycles of chemotherapy, receive multiple cycles of pegfilgrastim to avoid infections and substantial morbidity. The ABC phenomenon to pegfilgrastim appears to be the cause of loss of clinical benefit of sequential treatments with pegfilgrastim in patients.","ja":"Pegfilgrastimis a recombinant PEGylated human granulocyte colony-stimulating factor (G-CSF) analog filgrastim (trade names Neulasta® or G-Lasta®) that stimulates the production of white blood cells (neutrophils). It is employed as an alternative to filgrastim (G-CSF) for chemotherapy-induced neutropenia in patients due to its longer half-life. In clinical settings, PEG-G-CSF is administered to cancer patients via both the s.c. and i.v. routes. In a murine study, we showed that, regardless of administration route, initial doses of PEG-G-CSF above 0.06 mg/kg elicited anti-PEG immune response in a dose-dependent manner. I.v. administration elicited higher levels of anti-PEG IgM than the s.c. route. Initial doses of PEG-G-CSF (6 mg/kg) that were high enough to trigger production of anti-PEG IgM, did not trigger the accelerated clearance of a lower subsequent dose (0.06 mg/kg) that was similar to i.v. clinical doses of PEG-G-CSF, but when the subsequent dose of PEG-G-CSF was raised to (6 mg/kg), the initial dose triggered the accelerated clearance of the second dose via an anti-PEG IgM-mediated complement activation. Similar observations were noted when an increased PEG-OVA dose was given as the second dose, indicating that pre-existing and/or treatment-induced anti-PEG antibodies might compromise the therapeutic activity and/or reduce tolerance of other PEGylated formulations. To the best of our knowledge, this is the first report to suggest the induction of the ABC phenomenon upon repeated injections of pegfilgrastim. In the clinic, cancer patients, receiving multiple cycles of chemotherapy, receive multiple cycles of pegfilgrastim to avoid infections and substantial morbidity. The ABC phenomenon to pegfilgrastim appears to be the cause of loss of clinical benefit of sequential treatments with pegfilgrastim in patients."},"publication_date":"2020-07","publication_name":{"en":"European Journal of Pharmaceutics and Biopharmaceutics","ja":"European Journal of Pharmaceutics and Biopharmaceutics"},"volume":"Vol.152","starting_page":"56","ending_page":"62","languages":["eng"],"referee":true,"identifiers":{"doi":["10.1016/j.ejpb.2020.04.026"],"issn":["1873-3441"]},"published_paper_type":"scientific_journal"},"priority":"input_data"}
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