Preclinical toxicity biomarkers for combination treatment with clotting factors rFXIII and rFVIIa

Biomarkers

Volumn 12, Issue 4, 2007, Pages 424-444

  Oleksiewicz, M B ^a   Schaal Jensen, R ^a   Kiehr, B ^a   Krabbe, J Steenbuch ^a   Sommer, C ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

Biomarker; Cynomolgus monkey; rFVIIa; rFXIII; Toxicity; Western blot

Indexed keywords

BIOLOGICAL MARKER; BLOOD CLOTTING FACTOR; FIBRINOGEN; FIBRONECTIN; PLASMA PROTEIN; RECOMBINANT BLOOD CLOTTING FACTOR 13; RECOMBINANT BLOOD CLOTTING FACTOR 7A; UNCLASSIFIED DRUG; VITRONECTIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD CHEMISTRY; BLOOD CLOTTING DISORDER; CONTROLLED STUDY; DEATH; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG DOSE REGIMEN; FEMALE; HISTOPATHOLOGY; MALE; MONKEY; NONHUMAN; SCREENING TEST; SINGLE DRUG DOSE; TOXICITY TESTING; WESTERN BLOTTING;

ANIMALS; BIOLOGICAL MARKERS; BLOTTING, WESTERN; DRUG EVALUATION, PRECLINICAL; FACTOR VIIA; FACTOR XIII; FIBRINOGEN; FIBRONECTINS; HEMOSTATIC TECHNIQUES; HUMANS; MACACA FASCICULARIS; RECOMBINANT PROTEINS; VITRONECTIN;

ANIMALIA; MACACA FASCICULARIS;

EID: 34250786229     PISSN: 1354750X     EISSN: 13665804     Source Type: Journal    
DOI: 10.1080/13547500701308597     Document Type: Article

References (39)

1. Bale, MD, Westrick, LG and Mosher, DF (1985) Incorporation of thrombospondin into fibrin clots. The Journal of Biological Chemistry, 260, pp. 7502-7508.
2. Birndorf, NI, Pearson, JD and Wredman, A. (1971) The clotting system of monkeys: A comparison of coagulation factors and tests between cynomolgus monkeys (Macaca irus) and humans. Comparative Biochemistry and Physiology, 38, pp. 157-161.
3. Bishop, PD, Teller, DC, Smith, RA, Lasser, GW, Gilbert, T. and Seale, RL (1990) Expression, purification, and characterization of human factor XIII in Saccharomyces cerevisiae. Biochemistry, 29, pp. 1861-1869.
4. Chain, D., Korc-Grodzicki, B., Kreizman, T. and Shaltiel, S. (1991) Endogenous cleavage of the Arg-379-Ala-380 bond in vitronectin results in a distinct conformational change which 'buries' Ser-378, its site of phosphorylation by protein kinase A. The Biochemical Journal, 274, pp. 387-394.
5. Dempfle, CE, Argiriou, S., Kucher, K., Muller-Peltzer, H., Rubsamen, K. and Heene, DL (2000) Analysis of fibrin formation and proteolysis during intravenous administration of ancrod. Blood, 96, pp. 2793-2802.
6. Dodds, MG, Visich, JE and Vicini, P. (2005) Population pharmacokinetics of recombinant factor XIII in cynomolgus monkeys. The AAPS Journal, 7, pp. E693-E703.
7. Doolittle, RF (2003) X-ray crystallographic studies on fibrinogen and fibrin. Journal of Thrombosis and Haemostasis, 1, pp. 1559-1565.
8. Eigenbrot, C. (2002) Structure, function, and activation of coagulation factor VII. Current Protein & Peptide Science, 3, pp. 287-299.
9. Cao, Y., Hertzberg, KM and Grieninger, G. (1995) Fibrinogen alpha genes: conservation of bipartite transcripts and carboxy-terminal-extended alpha subunits in vertebrates. Genomics, 30, pp. 71-76.
10. Gaffney, PJ (2001) Fibrin degradation products. A review of structures found in vitro and in vivo. Annals of the New York Academy of Sciences, 936, pp. 594-610.
11. Hedner, U. (2002) General haemostatic agents-fact or fiction?. Pathophysiology of Haemostasis and Thrombosis, 32, pp. 33-36.
12. Hoffman, M. and Monroe, DM 3rd (2003) The action of high-dose factor VIIa (FVIIa) in a cell-based model of hemostasis. Disease-a-Month, 49, pp. 14-21.
13. Jurlander, B., Thim, L., Klausen, NK, Persson, E., Kjalke, M., Rexen, P., Jorgensen, TB, Ostergaard, PB, Erhardtsen, E. and Bjorn, SE (2001) Recombinant activated factor VII (rFVIIa): Characterization, manufacturing, and clinical development. Seminars in Thrombosis and Haemostasis, 27, pp. 373-384.
14. Karges, HE, Funk, KA and Ronneberger, H. (1994) Activity of coagulation and fibrinolysis parameters in animals. Arzneimittelforschung, 44, pp. 793-797.
15. Kaspereit, F., Doerr, B. and Dickneite, G. (2004) The effect of fibrinogen concentrate administration on coagulation abnormalities in a rat sepsis model. Blood Coagulation & Fibrinolysis, 15, pp. 39-43.
16. Keeney, M., Allan, DS, Lohmann, RC and Yee, IH (2005) Effect of activated recombinant human factor 7 (Niastase) on laboratory testing of inhibitors of factors VIII and IX. Laboratory Hematology, 11, pp. 118-123.
17. Koschnick, S., Konstantinides, S., Schafer, K., Crain, K. and Loskutoff, DJ (2005) Thrombotic phenotype of mice with a combined deficiency in plasminogen activator inhibitor 1 and vitronectin. Journal of Thrombosis and Haemostasis, 3, pp. 2290-2295.
18. Kost, C., Stuber, W., Ehrlich, HJ, Pannekoek, H. and Preissner, KT (1992) Mapping of binding sites for heparin, plasminogen activator inhibitor-1, and plasminogen to vitronectin's heparin-binding region reveals a novel vitronectin-dependent feedback mechanism for the control of plasmin formation. The Journal of Biological Chemistry, 267, pp. 12098-12105.
19. Levi, M. and Cate, H ten (1999) Disseminated intravascular coagulation. The New England Journal of Medicine, 341, pp. 586-592.
20. Lijnen, HR, Marafino Jr, BJ and Collen, D. (1984) In vitro fibrinolytic activity of recombinant tissue-type plasminogen activator in the plasma of various primate species. Journal of Thrombosis and Haemostasis, 52, pp. 308-310.
21. Mosher, DF (1984) Physiology of fibronectin. Annual Review of Medicine, 35, pp. 561-575.
22. Muszbek, L., Yee, VC and Hevessy, Z. (1999) Blood coagulation factor XIII: Structure and function. Thrombosis Research, 94, pp. 271-305.
23. Denis, CV, Subbarao, S., Degen, JL, Sato, TN, Hynes, RO and Wagner, DD (2000) Persistence of platelet thrombus formation in arterioles of mice lacking both von Willebrand factor and fibrinogen. The Journal of Clinical Investigation, 106, pp. 385-392.
24. Yuen, PS, Papalia, JM, Trevithick, JE, Sakai, T., Fassler, R., Hynes, RO and Wagner, DD (2003) Plasma fibronectin promotes thrombus growth and stability in injured arterioles. Proceedings of the National Academy of Sciences of the USA, 100, pp. 2415-2419.
25. Okada, M., Blomback, B., Chang, MD and Horowitz, B. (1985) Fibronectin and fibrin gel structure. The Journal of Biological Chemistry, 260, pp. 1811-1820.
26. Podor, TJ, Campbell, S., Chindemi, P., Foulon, DM, Farrell, DH, Walton, PD, Weitz, JI and Peterson, CB (2002) Incorporation of vitronectin into fibrin clots. Evidence for a binding interaction between vitronectin and gamma A/gamma' fibrinogen. The Journal of Biological Chemistry, 277, pp. 7520-7528.
27. Ponce, R., Armstrong, K., Andrews, K., Hensler, J., Waggie, K., Heffernan, J., Reynolds, T. and Rogge, M. (2005) Safety of recombinant human factor XIII in a cynomolgus monkey model of extracorporeal blood circulation. Toxicologic Pathology, 33, pp. 702-710.
28. Ponce, RA, Visich, JE, Heffernan, JK, Lewis, KB, Pederson, S., Lebel, E., Andrews-Jones, L., Elliott, G., Palmer, TE and Rogge, MC (2005) Preclinical safety and pharmacokinetics of recombinant human factor XIII. Toxicologic Pathology, 33, pp. 495-506.
29. Preissner, KT and Seiffert, D. (1998) Role of vitronectin and its receptors in haemostasis and vascular remodeling. Thrombosis Research, 89, pp. 1-21.
30. Rand, MD, Lock, JB, Veer, C van't, Gaffney, DP and Mann, KG (1996) Blood clotting in minimally altered whole blood. Blood, 88, pp. 3432-3445.
31. Rao, LV and Rapaport, SI (1990) Factor VIIa-catalyzed activation of factor X independent of tissue factor: Its possible significance for control of hemophilic bleeding by infused factor VIIa. Blood, 75, pp. 1069-1073.
32. Reheman, A., Gross, P., Yang, H., Chen, P., Allen, D., Leytin, V. and Freedman, J. (2005) Vitronectin stabilizes thrombi and vessel occlusion but plays a dual role in platelet aggregation. Journal of Thrombosis and Haemostasis, 3, pp. 875-883.
33. Reynolds, TC, Butine, MD, Visich, JE, Gunewardena, KA, MacMahon, M., Pederson, S., Bishop, PD and Morton, KM (2005) Safety, pharmacokinetics, and immunogenicity of single-dose rFXIII administration to healthy volunteers. Journal of Thrombosis and Haemostasis, 3, pp. 922-928.
34. Roberts, HR, Monroe 3rd, DM and Hoffman, M. (2004) Safety profile of recombinant factor VIIa. Seminars in Hematology, 41, pp. 101-108.
35. Telgt, DS, Macik, BG, McCord, DM, Monroe, DM and Roberts, HR (1989) Mechanism by which recombinant factor VIIa shortens the aPTT: Activation of factor X in the absence of tissue factor. Thrombosis Research, 56, pp. 603-609.
36. Toh, CH and Dennis, M. (2003) Current clinical practice. DIC 2002: A review of disseminated intravascular coagulation. Hematology, 8, pp. 65-71.
37. Visich, JE, Zuckerman, LA, Butine, MD, Gunewardena, KA, Wild, R., Morton, KM and Reynolds, TC (2005) Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: A randomized, placebo-controlled, double-blind, multi-dose study. Thrombosis and Haemostasis, 94, pp. 802-807.
38. Von Depka, M. (2002) NovoSeven: Mode of action and use in acquired haemophilia. Intensive Care Medicine, 28, pp. S222-S227.
39. Wolfenstein-Todel, C. and Mosesson, MW (1980) Human plasma fibrinogen heterogeneity: Evidence for an extended carboxyl-terminal sequence in a normal gamma chain variant (gamma'). Proceedings of the National Academy of Sciences of the USA, 77, pp. 5069-5073.