Target-mediated disposition model describing the dynamics of IL12 and IFNγ after administration of a mifepristone-inducible adenoviral vector for IL-12 expression in mice

AAPS Journal

Volumn 15, Issue 1, 2013, Pages 183-194

  Parra Guillen, Zinnia Patricia ^a   Janda, Alvaro ^a   Alzuguren, Pilar ^b   Berraondo, Pedro ^b   Hernandez Alcoceba, Ruben ^b   Troconiz, Iñaki F ^a  

^a UNIVERSITY OF NAVARRA   (Spain)

^b UNIVERSITY OF NAVARRA   (Spain)

Author keywords

cytokines; knock out mice and gene therapy; pharmacokinetic pharmacodynamic modelling; target mediated drug disposition

Indexed keywords

ADENOVIRUS VECTOR; GAMMA INTERFERON; GAMMA INTERFERON RECEPTOR; INTERLEUKIN 12; INTERLEUKIN 12 RECEPTOR; MIFEPRISTONE;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG DISPOSITION; FEMALE; GENE EXPRESSION; INTERNALIZATION; KNOCKOUT MOUSE; MOUSE; NONHUMAN; PROMOTER REGION; PROTEIN EXPRESSION; PROTEIN SYNTHESIS; TARGET MEDIATED DRUG DISPOSITION; UPREGULATION; WILD TYPE;

ADENOVIRIDAE; ANIMALS; FEMALE; GENETIC THERAPY; GENETIC VECTORS; INTERFERON-GAMMA; INTERLEUKIN-12; MICE; MICE, INBRED C57BL; MIFEPRISTONE; MODELS, BIOLOGICAL; RECEPTORS, INTERFERON;

EID: 84871946378     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9423-9     Document Type: Article

References (44)

1. Trinchieri G. Interleukin-12: a proinflammatory cytokine with immunoregulatory functions that bridge innate resistance and antigen-specific adaptive immunity. Annu Rev Immunol. 1995;13(1):251-76.
2. Wolf SF, Temple PA, Kobayashi M, Young D, Dicig M, Lowe L, et al. Cloning of cDNA for natural killer cell stimulatory factor, a heterodimeric cytokine with multiple biologic effects on T and natural killer cells. J Immunol. 1991;146(9):3074-84.
3. Colombo MP, Trinchieri G. Interleukin-12 in anti-tumor immunity and immunotherapy. Cytokine Growth Factor Rev. 2002;13(2):155-68. (Pubitemid 34229390)
4. Del Vecchio M, Bajetta E, Canova S, Lotze MT, Wesa A, Parmiani G, et al. Interleukin-12: biological properties and clinical application. Clin Cancer Res. 2007;13(16):4677-85. (Pubitemid 47294773)
5. Sangro B, Melero I, Qian C, Prieto J. Gene therapy of cancer based on interleukin 12. Curr Gene Ther. 2005;5(6):573-81. (Pubitemid 43009502)
6. Berraondo P, Prieto J, Gonzalez-Aseguinolaza G. Advances in interleukin-12 gene therapy for acquired liver diseases. Curr Gene Ther. 2009;9(2):62-71.
7. Qin L, Ding Y, Pahud DR, Chang E, Imperiale MJ, Bromberg JS. Promoter attenuation in gene therapy: interferon-γ and tumor necrosis factor-α inhibit transgene expression. Hum Gene Ther. 1997;8(17):2019-29. (Pubitemid 28072573)
8. Wang L, Hernández-Alcoceba R, Shankar V, Zabala M, Kochanek S, Sangro B, et al. Prolonged and inducible transgene expression in the liver using gutless adenovirus: a potential therapy for liver cancer. Gastroenterology. 2004;126(1):278-89. (Pubitemid 38040742)
9. Burcin MM, Schiedner G, Kochanek S, Tsai SY, O'Malley BW. Adenovirus-mediated regulable target gene expression in vivo. Proc Natl Acad Sci USA. 1999;96(2):355-60. (Pubitemid 29061212)
10. Gonzalez-Aparicio M, Alzuguren P, Mauleon I, Medina-Echeverz J, Hervas-Stubbs S, Mancheno U, et al. Oxaliplatin in combination with liver-specific expression of interleukin 12 reduces the immunosuppressive microenvironment of tumours and eradicates metastatic colorectal cancer in mice. Gut. 2011;60(3):341-9.
11. Reboredo M, Zabala M, Mauleon I, De LR, Kreppel F, Kochanek S, et al. Interleukin-12 inhibits liver-specific drug-inducible systems in vivo. Gene Ther. 2007;15(4):277-88. (Pubitemid 351223464)
12. Zhang L, Pfister M, Meibohm B. Concepts and challenges in quantitative pharmacology and model-based drug development. APPS J. 2008;10(4):552-9.
13. Agur Z, Vuk-Pavlovic S. Mathematical modeling in immunotherapy of cancer: personalizing clinical trials. Mol Ther. 2012;20(1):1-2.
14. Crettaz J, Berraondo P, Mauleón I, Ochoa L, Shankar V, Barajas M, et al. Intrahepatic injection of adenovirus reduces inflammation and increases gene transfer and therapeutic effect in mice. Hepatology. 2006;44(3):623-32. (Pubitemid 44433718)
15. Beal S, Sheiner L, Boeckmann A. NONMEM Users Guide. Icon Development Solutions 1989-2006.
16. Babij P, Psaltis G, Song D, Kulik J, Mollova N, Abruzzese RV, et al. "Blue heart": characterization of a mifepristone-dependent system for conditional gene expression in genetically modified animals. Biochim Biophys Acta. 2003;1627(1):15-25. (Pubitemid 36570467)
17. Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn. 2001;28(6):507-32. (Pubitemid 34289541)
18. Mager D, Krzyzanski W. Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm Res. 2005;22(10):1589-96. (Pubitemid 41355898)
19. Lindbom L, Pihlgren P, Jonsson N. PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79(3):241-57. (Pubitemid 41196689)
20. Ludden TM, Beal SL, Sheiner LB. Comparison of the Akaike Information Criterion, the Schwarz criterion and the F test as guides to model selection. J Pharmacokinet Pharmacodyn. 1994;22(5):431-45.
21. Wu C, Warrier RR, Carvajal DM, Chua AO, Minetti LJ, Chizzonite R, et al. Biological function and distribution of human interleukin-12 receptor ß chain. Eur J Immunol. 1996;26(2):345-50. (Pubitemid 26060240)
22. Wu C, Wang X, Gadina M, O'Shea JJ, Presky DH, Magram J. IL-12 receptor β2 (IL-12Rβ2)-deficient mice are defective in IL-12-mediated signaling despite the presence of high affinity IL-12 binding sites. J Immunol. 2000;165(11):6221-8.
23. Levy G. Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther. 1994;56(3):248-52. (Pubitemid 24323915)
24. Gibiansky L, Gibiansky E, Kakkar T, Ma P. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn. 2008;35(5):573-91.
25. Meibohm B. Population pharmacokinetic/pharmacodynamic analyses as the basis for dosing of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2011;50(12):823-4.
26. Rakhit A, Yeon MM, Ferrante J, Fettner S, Nadeau R, Motzer R, et al. Down-regulation of the pharmacokinetic-pharmacodynamic response to interleukin-12 during long-term administration to patients with renal cell carcinoma and evaluation of the mechanism of this "adaptive response" in mice. Clin Pharmacol Ther. 1999;65(6):615-29. (Pubitemid 29294025)
27. Li R, Deng F, Fu Y, Zhang Y, Wan H, Zhou D, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection and intravenous infusion of recombinant human interleukin-12 and recombinant human interleukin-12 combined with hepatitis B surface antigen in cynomolgus monkeys. Pharmacology. 2010;85(6):319-27.
28. Zeuzem S, Hopf U, Carreno V, Diago M, Shiffman M, Grüne S, et al. A phase I/II study of recombinant human interleukin-12 in patients with chronic hepatitis C. Hepatology. 1999;29(4):1280-7. (Pubitemid 29168766)
29. Abraham AK, Kagan L, Kumar S, Mager DE. Type I interferon receptor is a primary regulator of target-mediated drug disposition of interferon-β in mice. J Pharmacol Exp Ther. 2010;334(1):327-32.
30. Eppler SM, Combs DL, Henry TD, Lopez JJ, Ellis SG, Yi JH, et al. A target-mediated model to describe the pharmacokinetics and hemodynamic effects of recombinant human vascular endothelial growth factor in humans. Clin Pharmacol Ther. 2002;72(1):20-32. (Pubitemid 34833184)
31. Nadeau RR, Ostrowski C, Ni-Wu G, Liberato DJ. Pharmacokinetics and pharmacodynamics of recombinant human interleukin-12 in male rhesus monkeys. J Pharmacol Exp Ther. 1995;274(1):78-83.
32. Trinchieri G, Scott P. Interleukin-12: a proinflammatory cytokine with immunoregulatory functions. Res Immunol. 1995;146(7-8):423-31.
33. Finley SD, Gupta D, Cheng N, Klinke DJ. Inferring relevant control mechanisms for interleukin-12 signaling in naive CD4+ T cells. Immunol Cell Biol. 2011;89(1):100-10.
34. O'Donnell MA, Luo Y, Chen X, Szilvasi A, Hunter SE, Clinton SK. Role of IL-12 in the induction and potentiation of IFN-γ in response to bacillus calmette-guérin. J Immunol. 1999;163(8):4246-52. (Pubitemid 29474489)
35. Becskei A, Grusby MJ. Contribution of IL-12R mediated feedback loop to Th1 cell differentiation. FEBS Lett. 2007;581(27):5199-206. (Pubitemid 350018746)
36. Pestka S, Krause CD, Walter MR. Interferons, interferon-like cytokines, and their receptors. Immunol Rev. 2004;202(1):8-32. (Pubitemid 39576902)
37. Ikeda H, Old LJ, Schreiber RD. The roles of IFNγ in protection against tumor development and cancer immunoediting. Cytokine Growth Factor Rev. 2002;13(2):95-109. (Pubitemid 34229385)
38. Huang S, Hendriks W, Althage A, Hemmi S, Bluethmann H, Kamijo R, et al. Immune response in mice that lack the interferon-gamma receptor. Science. 1993;259(5102):1742-5. (Pubitemid 23114659)
39. Abraham AK, Krzyzanski W, Mager DE. Partial derivative - based sensitivity analysis of models describing target-mediated drug disposition. APPS J. 2007;9(2):181-9.
40. Bader T, Weitzerbin J. Nuclear accumulation of interferon gamma. Proc Natl Acad Sci USA. 1994;91(25):11831-5. (Pubitemid 24368557)
41. Cofano F, Moore SK, Tanaka S, Yuhki N, Landolfo S, Appella E. Affinity purification, peptide analysis, and cDNA sequence of the mouse interferon gamma receptor. J Biol Chem. 1990;265(7):4064-71.
42. Schreiber RD, Farrar MA, Hershey GK, Fernandez-Luna J. The structure and function of interferon-[gamma] receptors. Int J Immunopharmacol. 1992;14(3):413-9.
43. Ma P. Theoretical considerations of target-mediated drug disposition models: simplifications and approximations. Pharm Res. 2012;29(3):866-82.
44. Garg A, Balthasar JP. Investigation of the influence of FcRn on the distribution of IgG to the brain. AAPS J. 2009;11(3):553-7.