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Reviews

Emerging PEGylated drugs

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Pages 363-380 | Published online: 20 May 2009

Bibliography

  • Hamidi M, Azadi A, Rafiei P. Pharmacokinetic consequences of Pegylation. Drug Deliv 2006;13:399-409
  • Veronese FM, Pasut G. PEGylation, successful approach to drug delivery. Drug Discov Today 2005;10:1451-8
  • Mahmood I, Green MD. Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins. Clin Pharmacokinet 2005;44:331-47
  • Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2003;2:214-21
  • Pasut G, Veronese FM. Polymer-drug conjugation, recent achievements and general strategies. Prog Polym Sci 2007;32:933-61
  • Webster R, Didier E, Harris P, et al. PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metab Dispos 2007;35:9-16
  • Abuchowski A, McCoy JR, Palczuk NC, et al. Effect of covalent attachment of polyethylene glycol on immunogenicity and circulating life of bovine liver catalase. J Biol Chem 1977;252:3582-6
  • Pasut G, Guiotto A, Veronese FM. Protein, peptide and non-peptide drug PEGylation for therapeutic application. Expert Opin Ther Patents 2004;14(6):859-94
  • Farid SS. Process economics of industrial monoclonal antibody manufacture. J Chromatogr B 2007;848:8-18
  • Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev 2002;54:531-45
  • Blick S, Curran MP. Certolizumab Pegol in Crohn's disease. Biodrugs 2007;21:195-201
  • Maeda H, Wu J, Sawa T, et al. Tumor vascular permeability and the EPR effect in macromolecular therapeutics: a review. J Control Release 2000;65:271-84
  • Hershfield MS. Adenosine deaminase deficiency: clinical expression, molecular basis, and therapy. Semin Hematol 1998;35:291-8
  • Booth C, Hershfield M, Notarangelo L, et al. Management options for adenosine deaminase deficiency; proceedings of the EBMT satellite workshop (Hamburg, March 2006). Clin Immunol 2007;123:139-47
  • Chan B, Wara D, Bastian J, et al. Long-term efficacy of enzyme replacement therapy for Adenosine deaminase (ADA)-deficient Severe Combined Immunodeficiency (SCID). Clin Immunol 2005;117:133-43
  • Pasut G, Sergi M, Veronese FM. Anti-cancer PEG-enzymes: 30 years old, but still a current approach. Adv Drug Deliv Rev 2008;60:69-78
  • Graham ML. Pegaspargase: a review of clinical studies. Adv Drug Deliv Rev 2003;55:1293-302
  • Bailon P, Palleroni A, Schaffer CA, et al. Rational design of a potent, long-lasting form of interferon: A 40kDa branched polyethylene glycol-conjugated interferon alfa-2a for the treatment of hepatitis C. Bioconjug Chem 2001;12:195-202
  • Grace MJ, Lee S, Bradshaw S, et al. Site of pegylation and polyethylene glycol molecule size attenuate interferon-α antiviral and antiproliferative activities through the JAK/STAT signaling pathway. J Biol Chem 2005;280:6327-36
  • Wang Y, Youngster S, Bausch J, et al. Identification of the major positional isomer of pegylated interferon alpha-2b. Biochem 2000;39:10634-40
  • Lee S, McNemar C. Substantially pure histidine-linked protein polymer conjugates. US5985263; 1999
  • Veronese FM, Mero Anna. The impact of PEGylation on biological therapies. Biodrugs 2008;22:315-29
  • Pegasys™ product information. Roche, 2004. Available from: http://www.fda.gov/cder/foi/label/2007/103964s5120lbl.pdf [Last accessed 25 Feb 2009]
  • PegIntron™ product information. Schering-Plough, 2006. Available from: http://www.fda.gov/cder/foi/label/2006/103949s5124LBL.pdf [Last accessed 25 Feb 2009]
  • Bruno R, Sacchi P, Scagnolari C, et al. Pharmacodynamics of peginterferon alfa-2a and peginterferon alfa-2b in interferon-naïve patients with chronic hepatitis C: a randomized, controlled study. Aliment Pharmacol Ther 2007;26:369-76
  • Sulkowski MS, Lawitz E, Shiffman ML, et al. Final results of the IDEAL (individualized dosing efficacy versus flat dosing to assess optimal PEGylated interferon therapy) phase IIIb study. J Hepatol 2008;48(Suppl 2):S370-1
  • Pipeline Insight: Hepatitis C. Datamonitor, 2006. Available from: http://www.datamonitor.com/kc/pharma/Download.asp?R=DMHC2188&type=Report&itemHref=001DMHC2188.pdf [Last accessed 25 Feb 2009]
  • Hadziyannis SJ, Sette H Jr, Morgan TR, et al. Peginterferon alfa-2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140:346-55
  • Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa 2b plus ribavirin for the initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958-65
  • Fried MW. Side effects of therapy of hepatitis C and their management. Hepatol 2002;36:S237-44
  • Kinstler OB, Gabriel NC, Farrar CE, Deprince RB. N-terminally chemically modified protein compositions and methods. US5824784; 1998
  • Neulasta brand profile Annotation: Product information on Neulasta. Amgen Product information, 2008. Available at: http://www.amgen.com/medpro/products_neulasta.html [Last accessed 25 Feb 2009]
  • Amgen Signs Multi-Year Agreement with International Oncology Network for Aranesp, Neulasta and NEUPOGEN. Amgen Press release, 2002. Available from: http://www.amgen.com/media/media_pr_detail.jsp?year=2002;&releaseID=268988 [Last accessed 25 Feb 2009]
  • Parkinson C, Scarlett JA, Trainer PJ. Pegvisomant in the treatment of acromegaly. Adv Drug Deliv Rev 2003;55:1303-14
  • Somavert product information. Pfizer Pharmacia & Upjohn, 2008. Available from: http://www.pfizer.com/files/products/uspi_somavert.pdf [Last accessed 25 Feb 2009]
  • Kourlas H, Schiller DS. Pegaptanib sodium for the treatment of neovascular age-related macular degeneration: a review. Clin Ther 2006;28:36-44
  • Topf JM. CERA: third-generation erythropoiesis-stimulating agent. Expert Opin Pharmacother 2008;9:839-49
  • Mircera® Scientific Discussion, 2007. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/mircera/H-739-en1.pdf [Last accessed 25 Feb 2009]
  • Athwal D, Brown D, Weir A, et al. Antibody molecules having specificity for human tumor necrosis factor alfa and use thereof. WO0194585; 2001
  • Chapman AP, Antoniw P, Spitali M, et al. Therapeutic antibody fragments with prolonged in vivo half-lives. Nat Biotechnol 1999;17:780-3
  • Voulgar PV. Emerging drugs for rheumatoid arthritis. Exper Opin Emerging Drugs 2008;13:175-96
  • Gaberc-porekar V, Zore I, Podobnik B, Menart V. Obstacles and pitfalls in the PEGylation of therapeutic proteins. Curr Opin Drug Discov Devel 2008;11:242-50
  • Sato H. Enzymatic procedure for site-specific PEGylation of proteins. Adv Drug Deliv Rev 2002;54:487-504
  • Defrees S. Wang ZG, Xing R. et al. GlycoPEGylation of recombinant therapeutic proteins produced in Escherichia coli. Glycobiology 2006;16:833-43
  • Veronese FM. Peptide and protein PEGylation: a review of problems and solutions. Biomaterials 2001;22:405-17
  • Woghiren C, Sharma B, Stein S. Protected thiol-polyethylene glycol: a new activated polymer for reversible protein modification. Bioconjug Chem 1993;4:314
  • Puricase(PEGloticase) meets pre-specified primary efficacy endpoint in two replicate phase 3 studies, Savient Press release, 2007. Available from: http://investor.savient.com/releasedetail.cfm?ReleaseID=281657 [Last accessed 25 Feb 2009]
  • Schellenberger V, Stemmer WP, Wang C, et al. Unstructured recombinant polymers and uses thereof. US20080039341; 2008
  • Lee S, Greenwald RB, Mcguire J, et al. Drug delivery systems employing 1,6-elimination: releasable poly(ethylene glycol) conjugates of proteins. Bioconjug Chem 2000;12:162-9
  • Filpula D, Zhao H. Releasable PEGylation of proteins with customized linkers. Adv Drug Deliv Rev 2008;60:29-49
  • Sinhabanu AK, Thakker DR. Prodrugs of anticancer agents. Adv Drug Delivery Rev 1996;19:241-73
  • Maeda H. SMANCS and polymer-conjugated macromolecular drugs: advantages in cancer chemotherapy. Adv Drug Deliv Rev 1991;6:181-202
  • Maeda H, Seymour LW, Miyamoto Y. Conjugates of anticancer agents and polymers: advantages of macromolecular therapeutics in vivo. Bioconjug Chem 1992;3:351-62
  • Noguchi Y, Wun J, Duncan R, et al. Early phase tumor accumulation of macromolecules: a great difference in clearance rate between tumor and normal tissues. Jpn J Cancer Res 1998;89:307-14
  • Greenwald RB, Choe YH, Mcgurie J, Conover CD. Effective drug delivery by PEGylated drug conjugates. Adv Drug Deliv Rev 2003;55:217-50
  • Kelland L. Discontinued drugs in 2005: oncology drugs. Expert Opin Investig Drugs 2006;15:1309-18
  • Caliceti P, Veronese FM. Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates. Adv Drug Deliv Rev 2003;55:1261-77
  • Merck Serono and Ambrx to collaborate on development of next generation growth hormone products. Ambrx Press release, 2006. Available from: http://www.ambrx.com/wt/page/pr_1182284089 [Last accessed 25 Feb 2009]
  • Ambrx to present at the 24th annual JP Morgan healthcare conference. Ambrx Press release, 2006. Available from: http://www.ambrx.com/wt/page/pr_1136919630 [Last accessed 25 Feb 2009]
  • Protein DRUGS. Scientific strategies for increasing efficacy, safety and convenience for the next generation of therapeutics. West Conshohocken: CBI Meeting, 2006
  • Pharmacokinetics and tissue distribution of PEGylated G-CSF in SD rats. AAPS meeting abstracts, 2005. Available from: http://www.aapsj.org/abstracts/AM_2005/Staged/aaps2005-003069.pdf [Last accessed 25 Feb 2009]
  • Pharmacokinetics of DA-3021(PEGylated interferon α-2a) in SD rats, beagle dogs and cynomolgus monkeys. AAPS meeting abstract, 2003. Available from: http://www.aapsj.org/abstracts/AM_2003/AAPS2003-002053.pdf [Last accessed 25 Feb 2009]
  • Coiffier B, Mounier N, Bologna S, et al. Efficacy and safety of rasburicase (recombinant urate oxidase) for the prevention and treatment of hyperuricemia during induction chemotherapy of aggressive non-Hodgkin's lymphoma: results of the GRAAL1 (Groupe d'Etude des Lymphomes de l'Adulte Trial on Rasburicase Activity in Adult Lymphoma) study. J Clin Oncol 2003;21:4402-6
  • Goldman SC, Holcenberg JS, Finklestein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood 2001;97:2998-3003
  • Ganson NJ, Kelly SJ, Scarlett E, et al. 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 2005;8:R12
  • Sundy JS, Ganson NJ, Kelly SJ, et al. Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinant mammalian urate oxidase in patients with refractory gout. Arthritis Rheum 2007;56:1021-8
  • Savient's Puricase®(PEG-uricase) Phase 2 results show powerful anti-hyperuricemic activity in treatment-failure gout patients. Savient Press release, 2006. Available at: http://investor.savient.com/releasedetail.cfm?ReleaseID=201683 [Last accessed 25 Feb 2009]
  • Biggers K, Scheinfeld N. PEGloticase, a polyethylene glycol conjugate of uricase for the potential intravenous treatment of gout. Curr Opin Investig Drugs 2008;(9):422-9
  • Scott L, Lamb J, Smith S, Wheatley DN. Single amino acid (arginine) deprivation: rapid and selective death of cultured transformed and malignant cells. Br J Cancer 2000;83:800-10
  • Feun L, Savaraj N. PEGylated arginine deiminase: a novel anticancer enzyme agent. Exp Opin Investig Drugs 2006;15:815-22
  • Holtsberg FW, Ensor CM, Steiner MR, et al. Poly(ethylene glycol)(PEG) conjugated arginine deiminase: effects of PEG formulations on this pharmacological properties. J Control Rel 2002;80:259-71
  • Logan T, Feun L, Bomalaski JS, et al. Phase I/II testing of PEGylated arginine deiminase in metastatic melanoma. Proc Am Soc Clin Oncol 2003;22:Abs2855
  • Izzo F, Marra P, Beneduce G, et al. PEGylated arginine deiminase treatment of patients with unresectable hepatocellular carcinoma: results from phase I/II studies. J Clin Oncol 2004;22:1815-22
  • Shen LJ, Shen WC. Drug evaluation: ADI-PEG-20-a PEGylated arginine deiminase for arginine-auxotrophic cancers. Curr Opin Mol Ther 2006;8:240-8
  • Shen LJ, Lin WC, Beloussow K, Shen WC. Resistance to the anti-proliferative activity of recombinant arginine deiminase in cell culture correlates with the endogenous enzyme, argininosuccinate synthetase. Cancer Lett 2003;191:165-70
  • Bach SJ, Hawkins RA, Swaine D. A short method for the purification of arginase from ox liver. Biochem J 1963;89:263-5
  • Savoca KV, Abuchowski A, van Es T, et al. Preparation of a non-immunogenic arginase by the covalent attachment of polyethylene glycol. Biochem Biophys Acta 1979;578:47-53
  • Cheng PN, Lam T, Lam W, et al. PEGylated recombinant human arginase (rhArg-PEG5,000mw) inhibits the in vitro and in vivo proliferation of human hepatocellular carcinoma through arginine depletion. Cancer Res 2007;67:309-17
  • Product pipeline: GlutaDON. ME Medical Enzymes AG, 2008. Available from: http://www.medical-enzymes.com/ [Last accessed 25 Feb 2009]
  • Product pipeline: staphylokinase. ThromboGenics, 2006. Available from: http://www.thrombogenics.com/html/pipeline3.asp [Last accessed 25 Feb 2009]
  • Moreadith RW, Collen D. Clinical development of PEGylated recombinant staphylokinase(PEG-Sak) for bolus thrombolytic treatment of patients with acute myocardial infarction. Adv Drug Deliv Rev 2003;55:1337-45
  • Bomalaski JS, Holtsberg FW, Ensor CM, Clark MA. Uricase formulated with polyethylene glycol(uricase-PEG 20): biochemical rationale and preclinical studies. J Rheumatol 2002;29:1942-9
  • Lee SH, Lee S, Youn YS, et al. Synthesis, characterization, and pharmacokinetic studies of PEGylated glucagons-like peptide-1. Bioconjug Chem 2005;16:377-82
  • Lee S, Youn YS, Lee SH, et al. PEGylated glucagons-like peptide-1 displays preserved effects on insulin release in isolated pancreatic islets and improved biological activity in db/db mice. Diabetologia 2006;49:1608-11
  • Youn YS, Chae SY, Lee S, et al. Evaluation of therapeutic potentials of site-specific PEGylated glucagons-like peptide-1 isomers as a type 2 anti-diabetic treatment: insulinotropic activity, glucose-stabilizing capability, and proteolytic stability. Biochem Pharmacol 2007;73:84-93
  • Exposito' P, Barbero L, Caccia P, et al. PEGylation of growth hormone-releasing hormone (GRF) analogues. Adv Drug Del Rev 2003;55:1279-91
  • D'antonio M, Louveau I, Esposito P, et al. Pharmacodynamic evaluation of a PEGylated analogue of human growth hormone releasing factor in rats and pigs. Growth Horm IGF Res 2004;14:226-34
  • Youn YS, Lee KC. Site-specific PEGylation for high-yield preparation of Lys21-amine PEGylated growth hormone-releasing factor (GRF)(1-29) using a GFR(1-29) derivative FMOC-protected at Tyr1 and Lys12. Bioconjug Chem 2007;18:500-6
  • Felix et al. PEGylated peptides IV enhanced biological activity of site-directed PEGylated GRF analogs. Int J Pept Protein Res 1995;46:253-64
  • Youn YS, Na DH, Lee KC. High-yield production of biologically active mono-PEGylated salmon calcitonin by site-specific PEGylation. J Control Rel 2007;117:371-9
  • Youn YS, Jung JY, Oh SH, et al. Improved intestinal delivery of salmon calcitonin by Lys18-amine specific PEGylation: stability, permeability, pharmacokinetic behavior and in vivo hypocalcemic efficacy. J Control Rel 2006;114:334-42
  • Mansoor S, Youn YS, Lee KC. Oral delivery of PEGylated sCT (Lys18-modified) in rats: regional difference in stability and hypocalcemic effect. Pharm Dev Technol 2005;10:389-96
  • Lee KC, Park MO, Na DH, et al. Intranasal delivery of PEGylated salmon calcitonins: hypocalcemic effects in rats. Calcif Tissue Int 2003;73:545-9
  • ImClone and UCB to codevelop anticancer VEGFR2 antibody. ImClone Press release, 2005. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=97689&p=irol-newsArticle&ID=743414&highlight= [Last accessed 25 Feb 2009]
  • Ton NC, Parker GJ, Jackson A, et al. Phase I evaluation of CDP791, a PEGylated di-Fab′ conjugate that binds vascular endothelial growth factor receptor 2. Clin Cancer Res 2007;13:7113-8
  • Product pipeline: NKTR-118. Nektar, 2008. Available at: http://www.nektar.com/product_pipeline/cns_pain_oral_nktr-118 and119.html [Last accessed 25 Feb 2009]
  • Sahner D, Paaschen H, Marcantonio A, Eldon M. Results from a phase I, double-blind, randomized, placebo-controlled, multiple-dose study evaluating the safety, tolerability, and pharmacokinetics of oral doses of NKTR-118. J Pain 2008;9(Suppl 1):28
  • Antonian L, Burton K, Goodin R, et al. PEGylation governs the disposition and metabolism of irinotecan following administration of a novel PEG-Irinotecan conjugate. Eur J Cancer 2007;5(Suppl):115
  • NKTR-102, a novel PEGylated-irinotecan conjugate, results in sustained tumor growth inhibition in mouse models of human colorectal and lung tumors that is associated with increased and sustained tumor SN38 exposure. Nektar Product information, 2007. Available from: http://www.nektar.com/pdf/pipeline/NKTR-102/NKTR-102_Product_Fact_Sheet.pdf [Last accessed 25 Feb 2009]
  • Zhao H, Rubio B, Sapra P, et al. Novel prodrugs of SN38 using multiarm poly(ethylene glycol) linkers. Bioconjug Chem 2008;19:849-59
  • Maeda H, Sawa T, Konno T. Mechanism of tumor-targeted delivery of macromolecular drugs, including the EPR effect in solid tumor and clinical overview of the prototype polymeric drug SMANCS. J Control Rel 2001;6:47-61
  • Bailon P, Berthold W. Polyethylene glycol-conjugated pharmaceutical proteins. Pharmaceut Sci Techn Today 1998;1:352-6
  • Peters BG, Goeckner BJ. Ponzillo JJ, et al. Pegaspargase versus asparaginase in adult ALL: a pharmacoeconomic assessment. Formulary 1995;30:388-93
  • Kurre HA, Ettinger AG, Veenstra DL, et al. A pharmacoeconomic analysis of Pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children's Cancer Group study (CCG-1962). J Pediatr Hematol Oncol 2002;24:175-81
  • Eldar-Lissai A, Cosler LE, Culakova E, Lyman GH. Economic analysis of prophylactic Pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health 2008;11:172-9
  • Grieve R, Roberts J, Wright M, et al. Cost effectiveness of interferon α or Peginterferon α with ribavirin for histologically mild chronic hepatitis C. Gut 2006;55:1332-8
  • Sullivan S, Craxi A, Alberti A, et al. Cost effectiveness of Peginterferon α-2a plus ribavirin versus interferon α-2b plus ribavirin as initial therapy for treatment-naïve chronic hepatitis C. PharmacoEconomics 2004;22:257-65
  • Salomon JA, Weinstein MC, Hammitt JK, Goldie SJ. Cost-effectiveness of treatment for chronic hepatitis C infection in an evolving patient population. JAMA 2003;290:228-37
  • Shepherd J, Brodin HF, Cave CB, et al. Clinical- and cost-effectiveness of PEGylated interferon alfa in the treatment of chronic hepatitis C: a systemic review and economic evaluation. Int J Technol Assess Health Care 2005;21:47-54
  • Youn YS, Kwon MJ, Na DH, et al. Improved intrapulmonary delivery of site-specific PEGylated salmon calcitonin: optimization by PEG size selection. J Control Rel 2008;125:68-75
  • Calceti P, Salmaso S, Walker G. Bernkop-Schnűrch A. Development and in vivo evaluation of an oral insulin-PEG delivery system. Eur J Pharm Sci 2004;22:315-23
  • Chae SY, Jin CH, Shin HJ, et al. Preparation, characterization, and application of biotinylated and biotin-PEGylated glucagons-like peptide-1 analogues for enhanced oral delivery. Bioconjug Chem 2008;19:334-41
  • Kim TH, Lee H, Park TG. PEGylated recombinant human epidermal growth factor (rhEGF) for sustained release from biodegradable PLGA microspheres. Biomaterials 2002;23:2311-7
  • Park EJ, Na DH, Lee KC. In vitro release study of mono-PEGylated growth hormone-releasing peptide-6 from PLGA microspheres. Int J Pharm 2007;343:281-3
  • Maggon K. Monoclonal antibody ‘gold rush’. Curr Med Chem 2007;14:1978-87
  • Edwards CK, Martin SW, Seely J, et al. Design of PEGylated soluble tumor necrosis factor receptor type I (PEG sTNF-RI) for chronic inflammatory diseases. Adv Drug Del Rev 2003;55:1315-36
  • Amunix home information. Amunix, 2008. Available from: http://www.amunix.com/Home.html [Last accessed 25 Feb 2009]

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