Pharmacokinetics and pharmacodynamics of turoctocog alfa and N8-GP in haemophilia A dogs

Haemophilia

Volumn 18, Issue 6, 2012, Pages 941-947

  Agerso H ^a   Stennicke, H R ^a   Pelzer, H ^a   Olsen, E N ^a   Merricks, E P ^b   deFriess, N A ^b   Nichols, T C ^b   Ezban, M ^a  

^a NOVO NORDISK A S   (Denmark)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

Haemophilic dogs; N8 GP; NONMEM; Pharmacokinetics; rFVIII; Turoctocog alfa

Indexed keywords

N8 GP; RECOMBINANT BLOOD CLOTTING FACTOR 8; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BLOOD CLOTTING TIME; BLOOD SAMPLING; CONTROLLED STUDY; DOG; DRUG CLEARANCE; FEMALE; HEMOPHILIA A; MALE; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; SIMULATION; WHOLE BLOOD CLOTTING TIME;

ANIMALS; DOGS; FACTOR VIII; FEMALE; HALF-LIFE; HEMOPHILIA A; MALE; PARTIAL THROMBOPLASTIN TIME; POLYETHYLENE GLYCOLS; THROMBELASTOGRAPHY; WHOLE BLOOD COAGULATION TIME;

EID: 84868210960     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2012.02896.x     Document Type: Article

References (27)

1. Blanchette VS. Prophylaxis in the haemophilia population. Haemophilia 2010; 16(Suppl. 5): 181-8.
2. Manco-Johnson MJ, Abshire TC, Shapiro AD et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med 2007; 357: 535-44.
3. Saenko EL, Pipe SW. Strategies towards a longer acting factor VIII. Haemophilia 2006; 12(Suppl. 3): 42-51.
4. Thim L, Vandahl B, Karlsson J et al. Purification and characterization of a new recombinant factor VIII (N8). Haemophilia 2010; 16: 349-59.
5. Viuff D, Barrowcliffe T, Saugstrup T, Ezban M, Lillicrap D. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia 2011; 17: 695-702.
6. Elm T, Karpf DM, Ovlisen K et al. Pharmacokinetics and pharmacodynamics of a new recombinant FVIII (N8) in haemophilia A mice. Haemophilia 2012; 18: 139-45.
7. Karpf DM, Kjalke M, Thim L et al. Pharmacokinetics and ex vivo whole blood clot formation of a new recombinant FVIII (N8) in haemophilia A dogs. Haemophilia 2011; 17: e963-8.
8. Martinowitz U, Bjerre J, Brand B et al. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE®) - an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia 2011; 17: 854-9.
9. Stennicke HR, Kjalke M, Karpf D et al. A Novel B-Domain O-glycoPEGylated FVIII (N8-GP) Demonstrates Full Efficacy and Prolonged Effect in Hemophilic Mice Models, Submitted, 2012.
10. Stennicke R, Kjalke M, Moeller F, Johansen P, Oevli Sen K, Karpf D. Design of a novel long-acting recombinant coagulation factor VIII. Haemophilia 2010; 16(Suppl. 4): 40.
11. Elm T, Ezban M, Tranholm M, Stennicke H, Holmberg H. Glycopegylated rFVIII (N8-GP) has Prolonged Haemostatic Effect in Haemophilia A Mice. J Thromb Haemost 2011; 9(Suppl. 2): 116-116, Special Issue: SI.
12. Agersø H, Kristensen NR, Østergaard H et al. Clearance of rFVIIa and NN1731 after intravenous administration to Beagle dogs. Eur J Pharm Sci 2011; 42: 578-83.
13. Knudsen LB, Nielsen PF, Huusfeldt PO et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem 2000; 43: 1664-9.
14. McCarthy K, Stewart P, Sigman J et al. Pharmacokinetics of recombinant factor IX after intravenous and subcutaneous administration in dogs and cynomolgus monkeys. Thromb Haemost 2002; 87: 824-30.
15. Østergaard H, Bjelke JR, Hansen L et al. Prolonged half-life and preserved enzymatic properties of factor IX selectively PEGylated on native N-glycans in the activation peptide. Blood 2011; 118: 2333-41.
16. Schaub R, Garzone P, Bouchard P et al. Preclinical studies of recombinant factor IX. Semin Hematol 1998; 35(2 Suppl. 2): 28-32.
17. Sabatino DE, Lange AM, Altynova ES et al. Efficacy and safety of long-term prophylaxis in severe hemophilia A dogs following liver gene therapy using AAV vectors. Mol Ther 2011; 19: 442-9.
18. Smolen J, Landewe RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis 2009; 68: 797-804.
19. R Development Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, 2009. Available at: http://www.R-project.org.
20. Holmberg H, Elm T, Karpf D et al. GlycoPEGylated rFVIIa (N7-GP) has a prolonged hemostatic effect in hemophilic mice compared with rFVIIa. J Thromb Haemost 2011; 9: 1070-2.
21. Harris JM, Martin NE, Modi M. Pegylation: a novel process for modifying pharmacokinetics. Clin Pharmacokinet 2001; 40: 539-51.
22. Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2003; 2: 214-21.
23. Bjorkman S, Folkesson A, Berntorp E. In vivo recovery of factor VIII and factor IX: intra- and interindividual variance in a clinical setting. Haemophilia 2007; 13: 2-8.
24. Bolon-Larger M, Chamouard V, Bressolle F, Boulieu R. A limited sampling strategy for estimating individual pharmacokinetic parameters of coagulation factor VIII in patients with hemophilia A. Ther Drug Monit 2007; 29: 20-6.
25. Karafoulidou A, Suarez E, Anastasopoulou I et al. Population pharmacokinetics of recombinant factor VIII:C (ReFacto) in adult HIV-negative and HIV-positive haemophilia patients. Eur J Clin Pharmacol 2009; 65: 1121-30.
26. Dumont JA, Kamphaus GD, Fraley C et al. Factor VIII-Fc fusion protein shows extended half-life and hemostatic activity in hemophilia A dogs. ASH 2009; 119: 3024-30.
27. Mei B, Pan C, Jiang H et al. Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatment. Blood 2010; 116: 270-9.