64. N.J. Ganson, S.J. Kelly, E. Scarlett, J.S. Sundy, M.S. Hershfield, Control of hyperuricemia in
subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG),
in a phase I trial of subcutaneous PEGylated urate oxidase. Arthritis Res. Ther. 8(1), R12
(2006)
65. I.A. Ivens, W. Achanzar, A. Baumann, A. Brandli-Baiocco, J. Cavagnaro, M. Dempster et al.,
PEGylated biopharmaceuticals: current experience and considerations for nonclinical
development. Toxicol. Pathol. 43(7), 959–983 (2015)
66. S. Sharma, R.W. Johnson, T.A. Desai, XPS and AFM analysis of antifouling PEG interfaces
for microfabricated silicon biosensors. Biosens. Bioelectron. 20(2), 227–239 (2004)
67. P. Bedocs, J. Capacchione, L. Potts, R. Chugani, Z. Weiszhar, J. Szebeni et al.,
Hypersensitivity reactions to intravenous lipid emulsion in swine: relevance for lipid
resuscitation studies. Anesth. Analg. 119(5), 1094–1101 (2014)
68. J. Szebeni, Complement activation-related pseudoallergy: a new class of drug-induced acute
immune toxicity. Toxicology 216(2–3), 106–121 (2005)
69. J. Szebeni, G. Storm, Complement activation as a bioequivalence issue relevant to the
development of generic liposomes and other nanoparticulate drugs. Biochem. Biophys. Res.
Commun. 468(3), 490–497 (2015)
70. D.S. Alberts, D.J. Garcia, Safety aspects of pegylated liposomal doxorubicin in patients with
cancer. Drugs 54(Suppl 4), 30–35 (1997)
71. A.J. Andersen, S.H. Hashemi, T.L. Andresen, A.C. Hunter, S.M. Moghimi, Complement:
alive and kicking nanomedicines. J. Biomed. Nanotechnol. 5(4), 364–372 (2009)
72. J. Szebeni, Complement activation-related pseudoallergy caused by liposomes, micellar
carriers of intravenous drugs, and radiocontrast agents. Crit. Rev. Ther. Drug Carrier Syst. 18
(6), 567–606 (2001)
73. B. Uziely, S. Jeffers, R. Isacson, K. Kutsch, D. Wei-Tsao, Z. Yehoshua et al., Liposomal
doxorubicin: antitumor activity and unique toxicities during two complementary phase I
studies. J. Clin. Oncol. 13(7), 1777–1785 (1995)
74. O. Ringden, E. Andstrom, M. Remberger, B.M. Svahn, J. Tollemar, Allergic reactions and
other rare side-effects of liposomal amphotericin. Lancet 344(8930), 1156–1157 (1994)
75. J.P. Sculier, A. Coune, C. Brassinne, C. Laduron, G. Atassi, J.M. Ruysschaert et al.,
Intravenous infusion of high doses of liposomes containing NSC 251635, a water-insoluble
cytostatic agent. A pilot study with pharmacokinetic data. J. Clin. Oncol. 4(5), 789–797
(1986)
76. S.J. Levine, T.J. Walsh, A. Martinez, P.Q. Eichacker, G. Lopez-Berestein, C. Natanson,
Cardiopulmonary toxicity after liposomal amphotericin B infusion. Ann. Intern. Med. 114(8),
664–666 (1991)
77. A.H. Brouwers, D.J. De Jong, E.T. Dams, W.J. Oyen, O.C. Boerman, P. Laverman et al.,
Tc-99m-PEG-Liposomes for the evaluation of colitis in Crohn’s disease. J. Drug Target. 8(4),
225–233 (2000)
78. J. Szebeni, P. Bedocs, Z. Rozsnyay, Z. Weiszhár, R. Urbanics, L. Rosivall et al.,
Liposome-induced complement activation and related cardiopulmonary distress in pigs:
factors promoting reactogenicity of Doxil and Am Bisome. Nanomedicine 8(2), 176–184
(2012)
79. A. Chanan-Khan, J. Szebeni, S. Savay, L. Liebes, N.M. Rafique, C.R. Alving et al.,
Complement activation following first exposure to pegylated liposomal doxorubicin (Doxil):
possible role in hypersensitivity reactions. Ann. Oncol. 14(9), 1430–1437 (2003)
80. R.B. Laing, L.J. Milne, C.L. Leen, G.P. Malcolm, A.J. Steers, Anaphylactic reactions to
liposomal amphotericin. Lancet 344(8923), 682 (1994)
81. A.S. Abu Lila, Y. Uehara, T. Ishida, H. Kiwada, Application of polyglycerol coating to
plasmid DNA lipoplex for the evasion of the accelerated blood clearance phenomenon in
nucleic acid delivery. J. Pharm. Sci. 103(2), 557–566 (2014)
82. A.S. Abu Lila, K. Nawata, T. Shimizu, T. Ishida, H. Kiwada, Use of polyglycerol (PG),
instead of polyethylene glycol (PEG), prevents induction of the accelerated blood clearance
20 Immune Response to PEGylated Nanomedicines …
387
subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG),
in a phase I trial of subcutaneous PEGylated urate oxidase. Arthritis Res. Ther. 8(1), R12
(2006)
65. I.A. Ivens, W. Achanzar, A. Baumann, A. Brandli-Baiocco, J. Cavagnaro, M. Dempster et al.,
PEGylated biopharmaceuticals: current experience and considerations for nonclinical
development. Toxicol. Pathol. 43(7), 959–983 (2015)
66. S. Sharma, R.W. Johnson, T.A. Desai, XPS and AFM analysis of antifouling PEG interfaces
for microfabricated silicon biosensors. Biosens. Bioelectron. 20(2), 227–239 (2004)
67. P. Bedocs, J. Capacchione, L. Potts, R. Chugani, Z. Weiszhar, J. Szebeni et al.,
Hypersensitivity reactions to intravenous lipid emulsion in swine: relevance for lipid
resuscitation studies. Anesth. Analg. 119(5), 1094–1101 (2014)
68. J. Szebeni, Complement activation-related pseudoallergy: a new class of drug-induced acute
immune toxicity. Toxicology 216(2–3), 106–121 (2005)
69. J. Szebeni, G. Storm, Complement activation as a bioequivalence issue relevant to the
development of generic liposomes and other nanoparticulate drugs. Biochem. Biophys. Res.
Commun. 468(3), 490–497 (2015)
70. D.S. Alberts, D.J. Garcia, Safety aspects of pegylated liposomal doxorubicin in patients with
cancer. Drugs 54(Suppl 4), 30–35 (1997)
71. A.J. Andersen, S.H. Hashemi, T.L. Andresen, A.C. Hunter, S.M. Moghimi, Complement:
alive and kicking nanomedicines. J. Biomed. Nanotechnol. 5(4), 364–372 (2009)
72. J. Szebeni, Complement activation-related pseudoallergy caused by liposomes, micellar
carriers of intravenous drugs, and radiocontrast agents. Crit. Rev. Ther. Drug Carrier Syst. 18
(6), 567–606 (2001)
73. B. Uziely, S. Jeffers, R. Isacson, K. Kutsch, D. Wei-Tsao, Z. Yehoshua et al., Liposomal
doxorubicin: antitumor activity and unique toxicities during two complementary phase I
studies. J. Clin. Oncol. 13(7), 1777–1785 (1995)
74. O. Ringden, E. Andstrom, M. Remberger, B.M. Svahn, J. Tollemar, Allergic reactions and
other rare side-effects of liposomal amphotericin. Lancet 344(8930), 1156–1157 (1994)
75. J.P. Sculier, A. Coune, C. Brassinne, C. Laduron, G. Atassi, J.M. Ruysschaert et al.,
Intravenous infusion of high doses of liposomes containing NSC 251635, a water-insoluble
cytostatic agent. A pilot study with pharmacokinetic data. J. Clin. Oncol. 4(5), 789–797
(1986)
76. S.J. Levine, T.J. Walsh, A. Martinez, P.Q. Eichacker, G. Lopez-Berestein, C. Natanson,
Cardiopulmonary toxicity after liposomal amphotericin B infusion. Ann. Intern. Med. 114(8),
664–666 (1991)
77. A.H. Brouwers, D.J. De Jong, E.T. Dams, W.J. Oyen, O.C. Boerman, P. Laverman et al.,
Tc-99m-PEG-Liposomes for the evaluation of colitis in Crohn’s disease. J. Drug Target. 8(4),
225–233 (2000)
78. J. Szebeni, P. Bedocs, Z. Rozsnyay, Z. Weiszhár, R. Urbanics, L. Rosivall et al.,
Liposome-induced complement activation and related cardiopulmonary distress in pigs:
factors promoting reactogenicity of Doxil and Am Bisome. Nanomedicine 8(2), 176–184
(2012)
79. A. Chanan-Khan, J. Szebeni, S. Savay, L. Liebes, N.M. Rafique, C.R. Alving et al.,
Complement activation following first exposure to pegylated liposomal doxorubicin (Doxil):
possible role in hypersensitivity reactions. Ann. Oncol. 14(9), 1430–1437 (2003)
80. R.B. Laing, L.J. Milne, C.L. Leen, G.P. Malcolm, A.J. Steers, Anaphylactic reactions to
liposomal amphotericin. Lancet 344(8923), 682 (1994)
81. A.S. Abu Lila, Y. Uehara, T. Ishida, H. Kiwada, Application of polyglycerol coating to
plasmid DNA lipoplex for the evasion of the accelerated blood clearance phenomenon in
nucleic acid delivery. J. Pharm. Sci. 103(2), 557–566 (2014)
82. A.S. Abu Lila, K. Nawata, T. Shimizu, T. Ishida, H. Kiwada, Use of polyglycerol (PG),
instead of polyethylene glycol (PEG), prevents induction of the accelerated blood clearance
20 Immune Response to PEGylated Nanomedicines …
387