Predicting the effects of 8C2, a monoclonal anti-topotecan antibody, on plasma and tissue disposition of topotecan

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 41, Issue 1, 2014, Pages 55-69

  Shah, Dhaval K ^a   Balthasar, Joseph P ^a  

^a UNIVERSITY AT BUFFALO   (United States)

Author keywords

8C2; Intraperitoneal chemotherapy; Inverse targeting; Mathematical modeling; Monoclonal antibody; PBPK model; Topotecan

Indexed keywords

ANIMALS; ANTIBODIES, MONOCLONAL; COMPUTER SIMULATION; MALE; MICE; MODELS, THEORETICAL; TISSUE DISTRIBUTION; TOPOTECAN;

EID: 84895074016     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-013-9346-9     Document Type: Article

References (36)

1. Balthasar J, Fung HL (1994) Utilization of antidrug antibody fragments for the optimization of intraperitoneal drug therapy: studies using digoxin as a model drug. J Pharmacol Exp Ther 268(2):734-739
2. Balthasar JP, Fung HL (1995) High-affinity rabbit antibodies directed against methotrexate: production, purification, characterization, and pharmacokinetics in the rat. J Pharm Sci 84(1):2-6
3. Balthasar JP, Fung HL (1996) Inverse targeting of peritoneal tumors: selective alteration of the disposition of methotrexate through the use of anti-methotrexate antibodies and antibody fragments. J Pharm Sci 85(10):1035-1043
4. Lobo ED, Balthasar JP (2005) Application of anti-methotrexate Fab fragments for the optimization of intraperitoneal methotrexate therapy in a murine model of peritoneal cancer. J Pharm Sci 94(9):1957-1964
5. Lobo ED, Soda DM, Balthasar JP (2003) Application of pharmacokinetic- pharmacodynamic modeling to predict the kinetic and dynamic effects of anti-methotrexate antibodies in mice. J Pharm Sci 92(8):1665-1676
6. Faulstich H, Kirchner K, Derenzini M (1988) Strongly enhanced toxicity of the mushroom toxin alpha-amanitin by an amatoxin-specific Fab or monoclonal antibody. Toxicon 26(5):491-499
7. Fisher CJ Jr, Agosti JM, Opal SM, Lowry SF, Balk RA, Sadoff JC, Abraham E, Schein RM, Benjamin E (1996) Treatment of septic shock with the tumor necrosis factor receptor:Fc fusion protein The Soluble TNF Receptor Sepsis Study Group. N Engl J Med 334(26):1697-1702
8. May LT, Neta R, Moldawer LL, Kenney JS, Patel K, Sehgal PB (1993) Antibodies chaperone circulating IL-6. Paradoxical effects of anti-IL-6 "neutralizing" antibodies in vivo. J Immunol 151(6):3225-3236
9. Sato TA, Widmer MB, Finkelman FD, Madani H, Jacobs CA, Grabstein KH, Maliszewski CR (1993) Recombinant soluble murine IL-4 receptor can inhibit or enhance IgE responses in vivo. J Immunol 150(7):2717-2723
10. Chen J (2005) Optimization of intraperitoneal topotecan chemotherapy with anti-topotecan antibodies. PhD Thesis, Department of Pharmaceutical Sciences, SUNY at Buffalo: Chapter 6:187-215
11. Chen J (2005) Optimization of intraperitoneal topotecan chemotherapy with anti-topotecan antibodies. PhD Thesis, Department of Pharmaceutical Sciences, SUNY at Buffalo: Chapter 1; 1-45
12. Chen J (2005) Optimization of intraperitoneal topotecan chemotherapy with anti-topotecan antibodies. PhD Thesis, Department of Pharmaceutical Sciences, SUNY at Buffalo: Chapter 3; 81-123
13. Chen J, Balthasar JP (2007) Development and characterization of high affinity anti-topotecan IgG and Fab fragments. Handbook of pharmaceutical biotechnology. Wiley, Hoboken
14. Herben VM, ten Bokkel Huinink WW, Beijnen JH (1996) Clinical pharmacokinetics of topotecan. Clin Pharmacokinet 31(2):85-102
15. Rowinsky EK, Verweij J (1997) Review of phase I clinical studies with topotecan. Semin Oncol 24(6 Suppl 20):S20-27-S20-33
16. Shah DK, Balthasar JP (2011) Physiologically based pharmacokinetic model for topotecan in mice. J Pharmacokinet Pharmacodyn 38(1):121-142
17. Shah DK, Balthasar JP (2011) Improving the safety of intraperitoneal topotecan chemotherapy using a high affinity anti-topotecan antibody: a pharmacokinetic/toxicodynamic model development and evaluation. Int J Pharm (Manuscript in communication)
18. Garg A, Balthasar JP (2007) Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinet Pharmacodyn 34(5):687-709
19. Urva SR, Yang VC, Balthasar JP (2010) Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody. J Pharm Sci 99(3):1582-1600
20. Bernareggi A, Rowland M (1991) Physiologic modeling of cyclosporin kinetics in rat and man. J Pharmacokinet Biopharm 19(1):21-50
21. Khor SP, Mayersohn M (1991) Potential error in the measurement of tissue to blood distribution coefficients in physiological pharmacokinetic modeling. Residual tissue blood. I. Theoretical considerations. Drug Metab Dispos 19(2):478-485
22. Garg A (2007) Investigation of the role of FcRn in the absorption, distribution, and elimination of monoclonal antibodies. PhD Thesis, Department of Pharmaceutical Sciences, SUNY at Buffalo: Chapter 3; 71-111
23. Chen J, Balthasar JP (2005) High-performance liquid chromatographic assay for the determination of total and free topotecan in the presence and absence of anti-topotecan antibodies in mouse plasma. J Chromatogr B 816(1-2):183-192
24. Sullivan JB Jr (1987) Past, present, and future immunotherapy of snake venom poisoning. Ann Emerg Med 16(9):938-944
25. Seifert SA, Boyer LV (2001) Recurrence phenomena after immunoglobulin therapy for snake envenomations: Part 1. Pharmacokinetics and pharmacodynamics of immunoglobulin antivenoms and related antibodies. Ann Emerg Med 37(2):189-195
26. Heard K, O'Malley GF, Dart RC (1999) Antivenom therapy in the Americas. Drugs 58(1):5-15
27. Antman EM, Wenger TL, Butler VP Jr, Haber E, Smith TW (1990) Treatment of 150 cases of life-threatening digitalis intoxication with digoxin-specific Fab antibody fragments. Final report of a multicenter study. Circulation 81(6):1744-1752
28. Putterman C, Ben-Chetrit E, Caraco Y, Levy M (1991) Colchicine intoxication: clinical pharmacology, risk factors, features, and management. Semin Arthritis Rheum 21(3):143-155
29. Saravolatz LD, Wherry JC, Spooner C, Markowitz N, Allred R, Remick D, Fournel M, Pennington JE (1994) Clinical safety, tolerability, and pharmacokinetics of murine monoclonal antibody to human tumor necrosis factor-alpha. J Infect Dis 169(1):214-217
30. Hasan J, Jayson GC (2001) VEGF antagonists. Expert Opin Biol Ther 1(4):703-718
31. Betts AM, Clark TH, Yang J, Treadway JL, Li M, Giovanelli MA, Abdiche Y, Stone DM, Paralkar VM (2010) The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis. J Pharmacol Exp Ther 333(1):2-13
32. Mager DE, Jusko WJ (2001) General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn 28(6):507-532
33. Ghetie V, Ward ES (1997) FcRn: the MHC class I-related receptor that is more than an IgG transporter. Immunol Today 18(12):592-598
34. Ghetie V, Ward ES (2002) Transcytosis and catabolism of antibody. Immunol Res 25(2):97-113
35. Junghans RP (1997) Finally! The Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG. Immunol Res 16(1):29-57
36. Tabrizi MA, Tseng CM, Roskos LK (2006) Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 11(1-2):81-88