{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T15:48:12Z","timestamp":1762876092646,"version":"3.37.3"},"reference-count":37,"publisher":"Elsevier BV","issue":"1","license":[{"start":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:00:00Z","timestamp":1569888000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:00:00Z","timestamp":1569888000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["jpet.aspetjournals.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Pharmacology and Experimental Therapeutics"],"published-print":{"date-parts":[[2019,10]]},"DOI":"10.1124\/jpet.119.260067","type":"journal-article","created":{"date-parts":[[2019,7,31]],"date-time":"2019-07-31T18:44:01Z","timestamp":1564598641000},"page":"95-105","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":4,"title":["Evaluation of Factor VIII Polysialylation: Identification of a Longer-Acting Experimental Therapy in Mice and Monkeys"],"prefix":"10.1016","volume":"371","author":[{"given":"Helmut","family":"Glantschnig","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Bauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karima","family":"Benamara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Dockal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronika","family":"Ehrlich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herbert","family":"Gritsch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald","family":"H\u00f6barth","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank M.","family":"Horling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Kopic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Leidenm\u00fchler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit M.","family":"Reipert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanspeter","family":"Rottensteiner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanja","family":"Ruthsatz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald","family":"Schrenk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Schuster","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter L.","family":"Turecek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alfred","family":"Weber","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Wolfsegger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Friedrich","family":"Scheiflinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Werner","family":"H\u00f6llriegl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1124\/jpet.119.260067_bib1","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/2040620717746312","article-title":"Novel therapies and current clinical progress in hemophilia A","volume":"9","author":"Balkaransingh","year":"2018","journal-title":"Ther Adv Hematol"},{"key":"10.1124\/jpet.119.260067_bib2","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1258\/la.2010.009113","article-title":"Optimization, refinement and reduction of murine in vivo experiments to assess therapeutic approaches for haemophilia A","volume":"44","author":"Baumgartner","year":"2010","journal-title":"Lab Anim"},{"key":"10.1124\/jpet.119.260067_bib3","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1038\/ng0595-119","article-title":"Targeted disruption of the mouse factor VIII gene produces a model of haemophilia A","volume":"10","author":"Bi","year":"1995","journal-title":"Nat Genet"},{"key":"10.1124\/jpet.119.260067_bib4","doi-asserted-by":"crossref","first-page":"815","DOI":"10.2165\/00003088-200140110-00003","article-title":"Pharmacokinetics of coagulation factors: clinical relevance for patients with haemophilia","volume":"40","author":"Bj\u00f6rkman","year":"2001","journal-title":"Clin Pharmacokinet"},{"key":"10.1124\/jpet.119.260067_bib5","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1177\/2040620717721458","article-title":"Current and emerging factor VIII replacement products for hemophilia A","volume":"8","author":"Cafuir","year":"2017","journal-title":"Ther Adv Hematol"},{"key":"10.1124\/jpet.119.260067_bib6","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1021\/bc700319r","article-title":"Modulation of antibody pharmacokinetics by chemical polysialylation","volume":"19","author":"Constantinou","year":"2008","journal-title":"Bioconjug Chem"},{"key":"10.1124\/jpet.119.260067_bib7","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1021\/bc8005122","article-title":"Site-specific polysialylation of an antitumor single-chain Fv fragment","volume":"20","author":"Constantinou","year":"2009","journal-title":"Bioconjug Chem"},{"key":"10.1124\/jpet.119.260067_bib8","doi-asserted-by":"crossref","first-page":"488","DOI":"10.1111\/jth.12506","article-title":"Phase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A","volume":"12","author":"Coyle","year":"2014","journal-title":"J Thromb Haemost"},{"key":"10.1124\/jpet.119.260067_bib9","doi-asserted-by":"crossref","first-page":"987","DOI":"10.2165\/11207480-000000000-00000","article-title":"Octocog alfa, antihaemophilic factor (recombinant), plasma\/albumin free method (Advate\u00ae): a review of its use in the management of patients with haemophilia A","volume":"72","author":"Dhillon","year":"2012","journal-title":"Drugs"},{"key":"10.1124\/jpet.119.260067_bib10","doi-asserted-by":"crossref","first-page":"3024","DOI":"10.1182\/blood-2011-08-367813","article-title":"Prolonged activity of a recombinant factor VIII-Fc fusion protein in hemophilia A mice and dogs","volume":"119","author":"Dumont","year":"2012","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib11","first-page":"262","article-title":"Towards personalised therapy for von Willebrand disease: a future role for recombinant products","volume":"14","author":"Favaloro","year":"2016","journal-title":"Blood Transfus"},{"key":"10.1124\/jpet.119.260067_bib12","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1016\/S0378-5173(01)00603-2","article-title":"The effect of polysialylation on the immunogenicity and antigenicity of asparaginase: implication in its pharmacokinetics","volume":"217","author":"Fernandes","year":"2001","journal-title":"Int J Pharm"},{"key":"10.1124\/jpet.119.260067_bib13","doi-asserted-by":"crossref","first-page":"1964","DOI":"10.1007\/PL00000676","article-title":"Polysialic acids: potential in improving the stability and pharmacokinetics of proteins and other therapeutics","volume":"57","author":"Gregoriadis","year":"2000","journal-title":"Cell Mol Life Sci"},{"key":"10.1124\/jpet.119.260067_bib14","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1016\/j.ijpharm.2005.06.007","article-title":"Improving the therapeutic efficacy of peptides and proteins: a role for polysialic acids","volume":"300","author":"Gregoriadis","year":"2005","journal-title":"Int J Pharm"},{"key":"10.1124\/jpet.119.260067_bib15","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1016\/0014-5793(93)81177-2","article-title":"Polysialic acids: potential in drug delivery","volume":"315","author":"Gregoriadis","year":"1993","journal-title":"FEBS Lett"},{"key":"10.1124\/jpet.119.260067_bib16","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1111\/hae.13483","article-title":"Pharmacokinetic modelling and validation of the half-life extension needed to reduce the burden of infusions compared with standard factor VIII","volume":"24","author":"Hermans","year":"2018","journal-title":"Haemophilia"},{"key":"10.1124\/jpet.119.260067_bib17","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/S0304-4165(03)00116-8","article-title":"Polysialylated insulin: synthesis, characterization and biological activity in vivo","volume":"1622","author":"Jain","year":"2003","journal-title":"Biochim Biophys Acta"},{"key":"10.1124\/jpet.119.260067_bib18","doi-asserted-by":"crossref","first-page":"1078","DOI":"10.1182\/blood-2015-03-630897","article-title":"Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A","volume":"126","author":"Konkle","year":"2015","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib19","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1111\/bjh.13797","article-title":"New products for the treatment of haemophilia","volume":"172","author":"Laffan","year":"2016","journal-title":"Br J Haematol"},{"key":"10.1124\/jpet.119.260067_bib20","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1182\/blood-2013-10-529974","article-title":"Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A","volume":"123","author":"Mahlangu","year":"2014","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib21","doi-asserted-by":"crossref","first-page":"348","DOI":"10.1111\/hae.13438","article-title":"Defining extended half-life rFVIII-A critical review of the evidence","volume":"24","author":"Mahlangu","year":"2018","journal-title":"Haemophilia"},{"issue":"Suppl 1","key":"10.1124\/jpet.119.260067_bib22","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1111\/jth.12270","article-title":"Future of coagulation factor replacement therapy","volume":"11","author":"Peyvandi","year":"2013","journal-title":"J Thromb Haemost"},{"key":"10.1124\/jpet.119.260067_bib23","doi-asserted-by":"crossref","first-page":"1692","DOI":"10.1111\/j.1538-7836.2005.01367.x","article-title":"The promise and challenges of bioengineered recombinant clotting factors","volume":"3","author":"Pipe","year":"2005","journal-title":"J Thromb Haemost"},{"key":"10.1124\/jpet.119.260067_bib24","doi-asserted-by":"crossref","first-page":"2007","DOI":"10.1182\/blood-2016-04-713289","article-title":"Life in the shadow of a dominant partner: the FVIII-VWF association and its clinical implications for hemophilia A","volume":"128","author":"Pipe","year":"2016","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib25","doi-asserted-by":"crossref","first-page":"1940","DOI":"10.1111\/jth.12700","article-title":"Influence of genetic background on bleeding phenotype in the tail-tip bleeding model and recommendations for standardization: communication from the SSC of the ISTH","volume":"12","author":"Schiviz","year":"2014","journal-title":"J Thromb Haemost"},{"issue":"Suppl 4","key":"10.1124\/jpet.119.260067_bib26","first-page":"78","article-title":"Structural and functional characterization of preclinical and clinical batches of BAX 826, a PSAylated full-length recombinant FVIII","volume":"22","author":"Schrenk","year":"2016","journal-title":"Haemophilia"},{"year":"2014","series-title":"Blood coagulation protein conjugates","author":"Siekmann","key":"10.1124\/jpet.119.260067_bib27"},{"key":"10.1124\/jpet.119.260067_bib28","doi-asserted-by":"crossref","first-page":"4073","DOI":"10.1182\/blood-2011-08-374645","article-title":"CD4+ T-cell epitopes associated with antibody responses after intravenously and subcutaneously applied human FVIII in humanized hemophilic E17 HLA-DRB1*1501 mice","volume":"119","author":"Steinitz","year":"2012","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib29","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1111\/hae.12116","article-title":"von Willebrand factor contributes to longer half-life of PEGylated factor VIII in vivo","volume":"19","author":"Tang","year":"2013","journal-title":"Haemophilia"},{"issue":"Suppl 1","key":"10.1124\/jpet.119.260067_bib30","doi-asserted-by":"crossref","first-page":"S176","DOI":"10.1111\/jth.12929","article-title":"Half-life extended factor VIII for the treatment of hemophilia A","volume":"13","author":"Tiede","year":"2015","journal-title":"J Thromb Haemost"},{"key":"10.1124\/jpet.119.260067_bib31","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1111\/jth.12161","article-title":"Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A","volume":"11","author":"Tiede","year":"2013","journal-title":"J Thromb Haemost"},{"key":"10.1124\/jpet.119.260067_bib32","doi-asserted-by":"crossref","first-page":"1677","DOI":"10.2147\/PPA.S139851","article-title":"Treatment adherence in hemophilia","volume":"11","author":"Thornburg","year":"2017","journal-title":"Patient Prefer Adherence"},{"key":"10.1124\/jpet.119.260067_bib33","doi-asserted-by":"crossref","first-page":"5939","DOI":"10.1073\/pnas.83.16.5939","article-title":"A large region (approximately equal to 95 kDa) of human factor VIII is dispensable for in vitro procoagulant activity","volume":"83","author":"Toole","year":"1986","journal-title":"Proc Natl Acad Sci USA"},{"issue":"Suppl 1","key":"10.1124\/jpet.119.260067_bib34","first-page":"S29","article-title":"BAX 855, a PEGylated rFVIII product with prolonged half-life. Development, functional and structural characterisation","volume":"32","author":"Turecek","year":"2012","journal-title":"Hamostaseologie"},{"key":"10.1124\/jpet.119.260067_bib35","doi-asserted-by":"crossref","first-page":"3698","DOI":"10.1182\/blood-2010-11-316521","article-title":"Maintenance and break of immune tolerance against human factor VIII in a new transgenic hemophilic mouse model","volume":"118","author":"van Helden","year":"2011","journal-title":"Blood"},{"key":"10.1124\/jpet.119.260067_bib36","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1152\/jappl.1959.14.6.943","article-title":"Biologic assay of a thrombosis-inducing activity in human serum","volume":"14","author":"Wessler","year":"1959","journal-title":"J Appl Physiol"},{"key":"10.1124\/jpet.119.260067_bib37","first-page":"75","article-title":"Application of sialic acid\/polysialic acid in the drug delivery systems","volume":"9","author":"Zhang","year":"2014","journal-title":"Asian J Pharm Sci"}],"container-title":["The Journal of Pharmacology and Experimental Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022356524268567?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022356524268567?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1124\/jpet.119.260067","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,19]],"date-time":"2025-02-19T20:06:45Z","timestamp":1739995605000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022356524268567"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10]]},"references-count":37,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,10]]}},"alternative-id":["S0022356524268567"],"URL":"https:\/\/doi.org\/10.1124\/jpet.119.260067","relation":{},"ISSN":["0022-3565"],"issn-type":[{"type":"print","value":"0022-3565"}],"subject":[],"published":{"date-parts":[[2019,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Evaluation of Factor VIII Polysialylation: Identification of a Longer-Acting Experimental Therapy in Mice and Monkeys","name":"articletitle","label":"Article Title"},{"value":"The Journal of Pharmacology and Experimental Therapeutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1124\/jpet.119.260067","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2019 by The American Society for Pharmacology and Experimental Therapeutics","name":"copyright","label":"Copyright"}]}}