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

References

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