Safety pharmacology, toxicology and pharmacokinetic assessment of recombinant human ω-interferon produced from CHO-SS cells

Basic and Clinical Pharmacology and Toxicology

Volumn 99, Issue 1, 2006, Pages 62-70

  Buckwold, Victor E ^a   Lang, William ^b   Scribner, Curtis ^b   Blanchett, Dennis ^b   Alessi, Tom ^b   Langecker, Peter ^b  

^a Rosenstock Hall   (United States)

^b Research Triangle   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; INTERFERON ANTIBODY; OMEGA INTERFERON ANTIBODY; RECOMBINANT INTERFERON; RECOMBINANT OMEGA INTERFERON; UNCLASSIFIED DRUG;

ACUTE TOXICITY; AMES TEST; ANIMAL EXPERIMENT; ANTIVIRAL ACTIVITY; ARTICLE; CHO CELL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; EMBRYO; FEMALE; FETUS; GLYCOSYLATION; HEMOLYSIS; HUMAN; IN VITRO STUDY; MALE; MICRONUCLEUS TEST; MONKEY; MOUSE; NONHUMAN; PRIORITY JOURNAL; RABBIT; RAT; REPRODUCTIVE TOXICITY; SINGLE DRUG DOSE; TOXICITY; TOXICITY TESTING;

ANIMALS; ANTIVIRAL AGENTS; CARDIOVASCULAR PHYSIOLOGICAL PHENOMENA; CARDIOVASCULAR PHYSIOLOGY; CHO CELLS; CRICETINAE; ENZYME-LINKED IMMUNOSORBENT ASSAY; EXPLORATORY BEHAVIOR; FEMALE; HEMOLYSIS; HEPATITIS C; HUMANS; INJECTIONS, INTRA-ARTERIAL; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; INTERFERON TYPE I; KIDNEY FUNCTION TESTS; LIVER FUNCTION TESTS; MACACA FASCICULARIS; MICE; MOTOR ACTIVITY; MUTAGENICITY TESTS; MUTAGENS; NEUTRALIZATION TESTS; PREGNANCY; RABBITS; RATS; RATS, SPRAGUE-DAWLEY; RECOMBINANT PROTEINS; REPRODUCTION; RESPIRATORY FUNCTION TESTS;

ANIMALIA; HEPATITIS C VIRUS; MACACA FASCICULARIS; ORYCTOLAGUS CUNICULUS;

EID: 33745813570     PISSN: 17427835     EISSN: 17427843     Source Type: Journal    
DOI: 10.1111/j.1742-7843.2006.pto_365.x     Document Type: Article

References (36)

1. Adolf, G. R.: Monoclonal antibodies and enzyme immunoassays specific for human interferon (IFN) ω1: evidence that IFN-ω1 is a component of human leukocyte IFN. Virology 1990, 175, 410-417.
2. Adolf, G. R.: Human omega interferon - a review. Multiple Sclerosis 1995, 1, S44-S47.
3. Adolf, G. R., B. Fruhbeis, R. Hauptmann, I. Kalsner, I. Maurer-Fogy, E. Ostermann, E. Patzelt, R. Schwendenwein, W. Sommergruber & A. Zöphel: Human interferon ω1: isolation of the gene, expression in Chinese hamster ovary cells and characterization of the recombinant protein. Biochim. Biophys. Acta 1991, 1089, 167-174.
4. Ames, B. N., J. McCann & E. Yamasaki: Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mut. Res. 1975, 31, 347-364.
5. Antonelli, G.: Antibodies to interferon in patients undergoing IFN therapy: An update. J. Biol. Regulators Homeostat. Agents 1995, 9, 123-131.
6. Antonelli, G.: In vivo development of antibody to interferons: An update to 1996. J. Interferon Cytokine Res. 1996, 1, S39-S46.
7. Antonelli, G. & F. Dianzani: Development of antibodies to interferon beta in patients: Technical and biological aspects. Eur. Cytokine Netw. 1999, 10, 413-422.
8. Bertolotto, A., F. Deisenhammer, P. Gallo & P. Solberg Sorensen: Immunogenicity of interferon beta: Differences among products. J. Neurol. 2004, 251, suppl. 2. II15-II24.
9. Bonino, F., M. Baldi, F. Negro, F. Oliveri, P. Colombatto, G. Bellati & M. R. Brunetto: Clinical role of anti-interferon antibodies in the serum of chronic hepatits C patients treated with interferon-α. J. Interferon Cytokine Res. 1997, 17, S35-S38.
10. De Serres, F. J. & M. D. Sheary: The Salmonella mutagenicity assay: recommendations. Science 1979, 203, 563-565.
11. Dusheiko, G.: Side effects of alpha interferon in chronic hepatitis C. Hepatology 1997, 26, 112S-121S.
12. Giannelli, G., G. Antonelli, G. Fera, S. Del Veccho, E. Riva, C. Broccia, O. Schiraldi & F. Dianzani: Biological and clinical significance of neutralizing and binding antibodies to interferon-alpha (IFN-α) during therapy for chronic hepatitis C. Clin. Exp. Immunol. 1994, 97, 4-9.
13. Gorbakov, V., H. Kim, B. Oronsky & W. Lang: HCV RNA results from a phase II. randomized, open-label study of omega interferon (IFN) with or without ribavirin in IFN-naïve genotype 1 chronic HCV patients. American Association for the Study of Liver Diseases meeting, 2005, abstract 67651.
14. Haria, M. & P. Benfield: Interferon-α-2a A review of its pharmacological properties and therapeutic use in the management of viral hepatitis. Drugs 1995, 50, 873-896.
15. Hoffman, R. M., T. Berg, G. Teuber, O. Prummer, L. Leifeld, M. C. Jung, U. Spengler, S. Zeuzem, U. Hopf & G. R. Pape: Interferon-antibodies and the breakthrough phenomenon during ribavirin/ interferon-alpha combination therapy and interferon-alpha monotherapy of patients with chronic hepatitis C. Z. Gastroenterol. 1999, 37, 715-723.
16. Irwin, S.: Comprehensive observational assessment: Ia. A systematic quantitative procedure for assessing the behavioural and physiologic state of the mouse. Psychopharmacologica 1968, 13, 222-257.
17. Jetschmann, J.-U., H. Meisel, M. Moran, P. Langecker, W. Lang, D. Blanchett, J. Brack, P. von Wussow, M. Backmund, K. Lebentrau, N. Wodarz, W. Haiota, H. Trocha, H. Locks & M. Plauth: Open-label dose-rising study of omega-interferon in IFN-naïve patients with chronic hepatitis C. Digestive Disease Week meeting, 2002, abstract M-1454.
18. Leimer, I., H. Pell & J. Ellenberger: Statistical analysis of the micronucleus test with the Fisher-Pitman permutation test. In: Statistical methods in toxicology. Ed.: L. Hothorn. Proceedings of a EUROTOX workshop. Springer Verlag 1991.
19. Liang, T. J., B. Rehermann, L. B. Seeff & J. H. Hoofnagle: Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann. Int. Med. 2000, 132, 296-305.
20. Maron, D. M. & B. N. Ames: Revised methods for the Salmonella mutagenicity test. Mut. Res. 1983, 113, 173-215.
21. McHutchinson, J. G., P. J. Pockros, P. Langecker, D. Blanchett, W. Lang & M. Moran: Open-label phase 1b study of hepatitis C viral dynamics with omega interferon treatment. American Association for the study of Liver Diseases meeting, 2001, abstract P-100575.
22. Milella, M., G. Antonelli, T. Santantonio, M. Currenti, L. Monno, N. Mariano, G. Angarano, F. Dianzani & G. Pastore: Neutralizing antibodies to recombinant alpha-interferon and response to therapy in chronic hepatitis C virus infection. Liver 1993, 13, 146-150.
23. Milella, M., G. Antonelli, T. Santantonio, M. Currenti, L. Monno, O. Turriziani, G. Pastore & F. Dianzani: Treatment with natural IFN of hepatitis C patients with or without antibodies to recombinant IFN. Hepatogastroenterology 1995, 42, 201-204.
24. Nguyen, M. H. & E. B. Keefe: Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6. Clin. Gastroenterol. Hepatol. 2005, 10, suppl. 2, S97-S101.
25. Osborn, B. L., H. S. Olsen, B. Nardelli, J. H. Murray, J. X. H. Zhou, A. Garcia, G. Moody, L. S. Zaritskaya & C. Sung: Pharmacokinetic and pharmacodynamic studies of a human serum albumin-interferon-α fusion protein in cynomolgus monkeys. J. Pharmacol. Exp. Therap. 2002, 303, 540-548.
26. Pawlotsky, J. M.: Mechanisms of antiviral treatment efficacy and failure in chronic hepatitis C. Antiviral Res. 2003, 59, 1-11.
27. Pearlman, B. L: Hepatitis C treatment update. Amer. J. Med. 2004, 117, 344-352.
28. Plauth, M., J.-U. Jeutschmann, H. Meisel, P. von Wussow, J. Brack, H. Lochs, P. Langecker, W. Lang, D. Blanchett & M. Moran: Open-label study of omega-interferon in previously untreated HCV-infected patients. European Association for the Study of Liver meeting, 2002, abstract 2008.
29. Schellekens, H., J.-C. Ryff & P. H. Van Der Meide: Assays for antibodies to human interferon-α: The need for standardization. J. Interferon Cytokine Res. 1997, 17, S1-S8.
30. Schmid, W.: The micronucleus test. Mut. Res. 1975, 31, 9-15.
31. Simmonds, P., J. Bukh, C. Combet, G. Deleage, N. Enomoto, S. Feinstone, P. Halfon, G. Inchauspe, C. Kuiken, G. Maertens, M. Mizokami, D. G. Murphy, H. Okamoto, J. M. Pawlotsky, F. Penin, E. Sablon, T. Shin-I., L. J. Stuyver, H. J. Thiel, S. Viazov, A. J. Weiner & A. Widel: Consensus proposals for a unified system of nomenclature of hepatitis C virus genotypes. Hepatology 2005, 42, 962-973.
32. Stark, G. R., Kerr, I. M., Williams, B. R., Silverman, R. H. & R. D. Schreiber: How cells respond to interferons. Ann. Rev. Biochem. 1998, 67, 227-264.
33. Tanswell, P. & J. Koup: TopFit: a PC-based pharmacokinetic/ pharmacodynamic data analysis program. Int. J. Clin. Pharmacol. Therap. Tox. 1993, 31, 514-520.
34. Toon, S.: The relevance of pharmakokinetics in the development of biotechnology products. Eur. J. Drug Metab. Pharmakokinet. 1996, 21, 93-103.
35. Wilson, J. G. & J. Warkany: Teratology, principles and techniques. The University of Chicago Press, London, 1965.
36. Winter, C. A.: The potentiating effect of antihistamine drugs upon the sedative action of barbiturates. J. Pharmacol. Exp. Therap. 1948, 94, 7-11.