Saturable human neopterin response to interferon-α assessed by a pharmacokinetic-pharmacodynamic model

Journal of Translational Medicine

Volumn 11, Issue 1, 2013, Pages

  Jeon, Sangil ^a   Juhn, Jae Hyeon ^b   Han, Seunghoon ^a   Lee, Jongtae ^a   Hong, Taegon ^a   Paek, Jeongki ^a   Yim, Dong Seok ^a  

^a The Catholic University of Korea   (South Korea)

^b LG Chemical Ltd   (South Korea)

Author keywords

IFN ; Neopterin; NONMEM; PK PD modeling

Indexed keywords

ALPHA INTERFERON; ALPHA2A INTERFERON; HYALURONIC ACID; MACROGOL; NEOPTERIN; POLYMER; RECOMBINANT ALPHA2A INTERFERON;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOCOMPATIBILITY; CONTROLLED STUDY; CREATININE CLEARANCE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG FORMULATION; DRUG METABOLISM; GOOD CLINICAL PRACTICE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PROTEIN BLOOD LEVEL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SPRAY DRYING; SUSTAINED RELEASE FORMULATION;

DEMOGRAPHY; HUMANS; INTERFERON-ALPHA; MALE; MODELS, BIOLOGICAL; NEOPTERIN; RECOMBINANT PROTEINS; TIME FACTORS; YOUNG ADULT;

EID: 84884776640     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/1479-5876-11-240     Document Type: Article

References (27)

1. Pfeffer LM, Dinarello CA, Herberman RB, Williams BR, Borden EC, Bordens R, Walter MR, Nagabhushan TL, Trotta PP, Pestka S. Biological properties of recombinant α-interferons: 40th anniversary of the discovery of interferons. Cancer Res 1998, 58:2489-2499.
2. Stark GR, Kerr IM, Williams BR, Silverman RH, Schreiber RD. How cells respond to interferons. Annu Rev Biochem 1998, 67:227-264. 10.1146/annurev.biochem.67.1.227, 9759489.
3. Bao Q, Zhao Y, Niess H, Conrad C, Schwarz B, Jauch K-W, Huss R, Nelson PJ, Bruns CJ. Mesenchymal stem cell-based tumor-targeted gene therapy in gastrointestinal cancer. Stem Cells Dev 2012, 21:2355-2363. 10.1089/scd.2012.0060, 3424981, 22530882.
4. Samarajiwa SA, Wilson W, Hertzog PJ. Type I interferons: genetics and structure 2006, Characterization and Application: The Interferons.
5. Jonasch E, Haluska FG. Interferon in oncological practice: review of interferon biology, clinical applications, and toxicities. Oncologist 2001, 6:34-55. 10.1634/theoncologist.6-1-34, 11161227.
6. Hoofnagle JH, Lau D. Chronic viral hepatitis - benefits of current therapies. N Engl J Med 1996, 334:1470-1471. 10.1056/NEJM199605303342210, 8618588.
7. Lutchman G, Hoofnagle JH. Viral kinetics in hepatitis C. Hepatology 2003, 37:1257-1259. 10.1053/jhep.2003.50238, 12774002.
8. Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med 2000, 132:296-305. 10.7326/0003-4819-132-4-200002150-00008, 10681285.
9. McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling M-H, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med 1998, 339:1485-1492. 10.1056/NEJM199811193392101, 9819446.
10. Milella M, Antoneill G, Santantonio T, Currenti M, Monno L, Mariano N, Angarano G, Dianzanl F, Pastors G. Neutralizing antibodies to recombinant alpha-interferon and response to therapy in chronic hepatitis C virus infection. Liver 1993, 13:146-150.
11. Caliceti P. Pharmacokinetics of pegylated interferons: what is misleading?. Dig Liver Dis 2004, 36:S334-S339.
12. Roberts M, Bentley M, Harris J. Chemistry for peptide and protein PEGylation. Adv Drug Deliv Rev 2002, 54:459-476. 10.1016/S0169-409X(02)00022-4, 12052709.
13. Grace M, Youngster S, Gitlin G, Sydor W, Xie L, Westreich L, Jacobs S, Brassard D, Bausch J, Bordens R. Structural and biologic characterization of pegylated recombinant IFN-α2b. J Interferon Cytokine Res 2001, 21:1103-1115. 10.1089/107999001317205240, 11798469.
14. Choi SY, Jeh HS. Sustained release composition of protein drug 2006, WO Patent 2,006,088,336.
15. Murr C, Widner B, Wirleitner B, Fuchs D. Neopterin as a marker for immune system activation. Curr Drug Metab 2002, 3:175-187. 10.2174/1389200024605082, 12003349.
16. Hu X, Olivier K, Polack E, Crossman M, Zokowski K, Gronke RS, Parker S, Li Z, Nestorov I, Baker DP. In vivo pharmacology and toxicology evaluation of polyethylene glycol-conjugated interferon β-1a. J Pharmacol Exp Ther 2011, 338:984-996. 10.1124/jpet.111.180661, 21690216.
17. Pepinsky RB, LePage DJ, Gill A, Chakraborty A, Vaidyanathan S, Green M, Baker DP, Whalley E, Hochman PS, Martin P. Improved pharmacokinetic properties of a polyethylene glycol-modified form of interferon-β-1a with preserved in vitro bioactivity. J Pharmacol Exp Ther 2001, 297:1059-1066.
18. Colburn WA, Eldon MA. Simultaneous pharmacokinetic/pharmacodynamic modeling 1994, New York: Wiley.
19. García-García I, González-Delgado CA, Valenzuela-Silva CM, Díaz-Machado A, Cruz-Díaz M, Nodarse-Cuní H, Pérez-Pérez O, Bermúdez-Badell CH, Ferrero-Bibilonia J, Páez-Meireles R. Pharmacokinetic and pharmacodynamic comparison of two "pegylated" interferon alpha-2 formulations in healthy male volunteers: a randomized, crossover, double-blind study. BMC Pharmacol 2010, 10:15. 3001701, 21092287.
20. Licko V, Ekblad E. Dynamics of a metabolic system: what single-action agents reveal about acid secretion. Am J Physiol Gastrointest Liver Physiol 1992, 262:G581-G592.
21. Zuideveld KP, Maas HJ, Treijtel N, Hulshof J, van der Graaf PH, Peletier LA, Danhof M. A set-point model with oscillatory behavior predicts the time course of 8-OH-DPAT-induced hypothermia. Am J Physiol-Regul, Integ Comp Physiol 2001, 281:R2059-R2071.
22. Gastl G, Aulitzky W, Tilg H, Nachbaur K, Troppmair J, Flener R, Huber C. A biological approach to optimize interferon treatment in hairy cell leukemia. Immunobiology 1986, 172:262-268. 10.1016/S0171-2985(86)80107-3, 3804368.
23. De Leede LG, Humphries JE, Bechet AC, Van Hoogdalem EJ, Verrijk R, Spencer DG. Novel controlled-release lemna-derived IFN-α 2b (locteron): pharmacokinetics, pharmacodynamics, and tolerability in a phase I clinical trial. J Interferon Cytokine Res 2008, 28:113-122. 10.1089/jir.2007.0073, 18279106.
24. Motzer RJ, Rakhit A, Ginsberg M, Rittweger K, Vuky J, Yu R, Fettner S, Hooftman L. Phase I trial of 40-kd branched pegylated interferon alfa-2a for patients with advanced renal cell carcinoma. J Clin Oncol 2001, 19:1312-1319.
25. Glue P, Fang JW, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, Salfi M, Jacobs S. Pegylated interferon-α2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Clin Pharmacol Ther 2000, 68:556-567. 10.1067/mcp.2000.110973, 11103758.
26. Berdowska A, Zwirska-Korczala K. Neopterin measurement in clinical diagnosis. J Clin Pharm Ther 2001, 26:319-329. 10.1046/j.1365-2710.2001.00358.x, 11679022.
27. Hoffmann G, Wirleitner B, Fuchs D. Potential role of immune system activation-associated production of neopterin derivatives in humans. Inflamm Res 2003, 52:313-321. 10.1007/s00011-003-1181-9, 14504669.