Overview of Clinical Applications of Type I Interferons

The Interferons: Characterization and Application

Volumn , Issue , 2006, Pages 275-308

  Müller, Frank ^a  

^a Rhein Minaphasm Biogenetics   (Egypt)

Author keywords

Biological effects; Clinical applications of type I interferons; IFN toxicity; Pharmacokinetics

Indexed keywords

EID: 84889303074     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/3527608206.ch10     Document Type: Chapter

References (141)

1. Cantell K. The Story of Interferon (The Ups and Downs in the Life of a Scientist). World Scientific Publishing, Singapore, 1998.
2. Isaacs A, Lindenmann J. Virus interference. I. The interferon. Proc Roy Soc Lond B 1957, 147, 258-267.
3. Pestka S. The human interferon-alpha species and hybrid proteins. Semin Oncol 1997, 24 (Suppl 9), S9-4-S9-17.
4. Jonasch E, Haluska FG. Interferon in oncological practice: review of interferon biology, clinical applications, and toxicities. The Oncologist 2001, 6, 34-55.
5. Pfeffer LM, Dinarello CA, Herbermann RB, et al. Biological properties of recombinant aIFN-40th anniversary of the discovery of Interferons. Cancer Res 1998, 58, 2489-2499.
6. Gellissen G. Hansenula polymorpha-Biology and Application. Wiley-VCH, Weinheim, 2002.
7. Gellissen G. Production of Recombinant Proteins. Wiley-VCH, Weinheim, 2005.
8. www.phrma.org/newmedicines/resources/2004-10-25.145.pdf; accessed 27 June 2005.
9. www.gdch.de/taetigkeiten/nch/down/biopharmazeutika.pdf; accessed 27 June 2005.
10. Rader RA. Biopharma: Biopharmaceutical Products in the US Market. 3rd edn. BioPlan, Rockville, MD, Sept. 2004, pp. 157-190.
11. The Cytokine Handbook, 3rd edn. Academic Press, New York, Editor: Agnus Thomson 1998.
12. Alferon N; www.hemispherx.net/content/products/product_brochure.htm; accessed 27 June 2005.
13. Müller F II, Tieke A, Waschk D, et al. Production of IFN-a-2a in Hansenula polymorpha. Process Biochem 2001, 38, 15-25.
14. Infergen; www.intermune.com/pdf/infergen_pi.pdf; accessed June 2005.
15. www.igb.fraunhofer.de; accessed 27 June 2005.
16. Wang YS, Youngster ST, Grace M, et al. Structural and biological characterisation of pegylated recombinant interferon alpha-2b and its therapeutic implications. Adv Drug Del Rev 2002, 54, 547-570.
17. Bailon P, Palleroni A, Carol A, et al. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon a-2a for the treatment of hepatitis C. Bioconjugate Chem 2001, 12, 195-201.
18. Glue P, Fang JWS, Rouzier-Panis R, et al. Pegylated interferon-a2b: pharmacokinetics, pharmacodynamics, and preliminary efficacy data. Clin Pharmacol Ther 2000, 68, 556-567.
19. Milton Harris J, Chess RB. Effect of pegylation on pharmaceuticals. Nat Drug Disc Rev 2003, 2, 214-221.
20. Wills RJ. Clinical pharmacokinetics of interferons. Clin Pharmacokinet 1990, 19, 390-399.
21. www.eudra.org/humandocs/PDFs/EPAR/Introna/267299FI2.pdf; accessed 27 June 2005.
22. www.introna.com/introna/index.jsp; accessed 27 June 2005.
23. www.rocheusa.com/products/roferon/pi.pdf; accessed 27 June 2005.
24. Volkenandt M, Hallek M, Schmid-Wendtner MH, et al. Adjuvante medikamentöse Therapie des malignen Melanoms. In: Maligne Melanome. Tumorzentrum, München, 2000.
25. Kirkwood JM, Strawdermann MH, Ernsthoff MS, et al. Interferon a-2b adjuvant therapy of high risk resected cutaneous melanoma. The Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol 1996, 14, 7-17.
26. Kirkwood JM, Ibrahim J, Sondak V, et al. Prelimanary analysis of the E1690/S9111/C9190 intergroups postoperative adjuvant trial of high and low dose IFN a2b in high risk primary or lymphnode metastatic melanoma. Proc Am Ass Clin Oncol 1999, 18, 2072.
27. Pehamberger H, Soyer HP, Steiner A, et al. Adjuvant interferon a-2a treatment in resected primary Stage II cutaneous melanoma. J Clin Oncol 1998, 16, 1425-1429.
28. Grob JJ, Dreno B, de la Salmoniere P, et al. Randomized trial of IFN-a2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. Lancet 1998, 351, 1905-1910.
29. www.nlm.nih.gov/medlineplus/kaposissarcoma.html; accessed 27 June 2005.
30. Andreoni M, Sarmat L, Nicastri E, et al. Primary human Herpesvirus-8 infection in immunocompetent children. J Am Med Ass 2002, 287, 1295-1300.
31. Aoki Y, Tosato G. HIV-1 Tat enhances KSHV infectivity. Blood 2004, 104, 810-814.
32. hiv.net/2010/buch/ks.htm; accessed 27 June 2005.
33. Thoma-Greber E, Sander CA, Messer G, et al. Pegyliertes IFN-a-2b: Neue Therapie bei klassischem KS. Klinik Münchener Fortbildungswoche für Dermatologen, München, 2002.
34. www.hemispherx.net/content/products/product_brochure.htm; accessed 27 June 2005.
35. Druker BJ, Sawyers CL, Capdeville R, et al. Chronic myelogenous leukemia. Hematology 2001, 87-112.
36. Silver RT, Woolf SH, Hehlmann R, et al. An evidence based analysis of the effect of busulfan, hydroxyurea, interferon and allogeneic bone marrow transplantation in treating the chronic phase of CML. Blood 1999, 94, 1517-1536.
37. The Italian Cooperative Study Group on CML. ''Interferonalpha-2a as compared with convertion chemotheraphy for the treatment of chronic myeloid leukemia''. N Engl J Med 1994, 330, 820-825.
38. Ohnishi K, Ohno R, Tomonaga M, et al. A randomized trial comparing interferon-alpha with busulfan for newly diagnosed chronic myelogenous leukemia in chronic phase. Blood 1995, 86, 906-916.
39. Broustet A, Reiffers J, Marit G, et al. Hydroxyurea versus interferon-alfa-2b in chronic myelogenous leukemia: preliminary results of an open French multicentre randomized study. Eur J Cancer 1991, 27 (Suppl 4), 18-21.
40. Kantarjian HM, Keating MJ, Estey EH, et al. Treatment of Philadelphia chromosome-positive early chronic myelogenous leukemia with daily doses of interferon-alpha and low-dose cytarabine. J Clin Oncol 1999, 17, 284-292.
41. Guilhot F, Chastang C, Michallet M, et al. Interferon alfa-2b combined with cytarabine versus interferon alone in chronic myelogenous leukemia. French Chronic Myeloid Leukemia Study Group. N Engl J Med 1997, 337, 223-229.
42. Kuzel TM, Roenikg HH, Samuelson E, Jr., et al. Effectiveness of interferon-alfa-2a combined with phototherapy for Mycosis Fungoides and the Sézary Syndrome. J Clin Oncol 1995, 13, 257-263.
43. www.emedicine.com; accessed 27 June 2005.
44. www.cancer.gov/cancertopics/pdq/treatment/mycosisfungoides; accessed 27 June 2005.
45. www.nidcd.nih.gov/health/voice/laryngeal.asp; accessed 27 June 2005.
46. Armbruster C, Kreuzer A, Vorbach H, et al. Successful treatment of severe respiratory papillomatosis with intravenous cidofovir and interferon a-2b. Eur Respir J 2001, 17, 830-831.
47. Snoeck R, Wellens W, Desloovere C. Treatment of severe Laryngeal Papillomatosis with intralesional injections of cidofovir. J Med Virol 1998, 54, 219-225.
48. Nordarse-Cuní H, Iznaga-Marín N, Viera-Alvarez D, et al. Interferon alpha-2b as adjuvant treatment of recurrent respiratory papillomatosis in Cuba: National programme (1994-1999 report). J Laryngol Otol 2004, 118, 681-687.
49. www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_Is_Non_ Hodgkins_Lymphoma_32.asp; accessed 27 June 2005.
50. www.nci.nih.gov/cancertopics/pdq/treatment/adult-nonhodgkins/patient/all pages; accessed 27 June 2005.
51. Rohatiner AZS, Gregory WM, Peterson B. Meta-analysis to evaluate the role of interferon in Follicular Lymphoma. J Clin Oncol 2005, 23, 2215-2223.
52. Louie AC, Gallagher JC, Sikora K, et al. Follow up observations on the effect of human leukocyte interferon in non-Hodgkin's lymphoma. Blood 1981, 58, 712-718.
53. Leavitt J, Ratanathathorn V, Ozer H, et al. Alfa-2b Interferon in the treatment of Hodgkin disease and non-Hodgkin's lymphoma. Semin Oncol 1987, 14 (Suppl 2), 18-23.
54. www.nlm.nih.gov/medlineplus/ency/article/000516.htm; accessed 27 June 2005.
55. Oiver RTD, Nethersell ABW, Bottomley JM. Unexplained spontaneous regression and alpha-interferon as treatment for metastatic renal carcinoma. Br J Urol 1989, 63, 128-131.
56. Ritchie AWS. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomized controlled trial. Medical Research Council Renal Cancer Collaborators. Lancet 1999, 353, 14-17.
57. Pyrhonen S, Salminen E, Ruutu M, et al. Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol 1999, 17, 2859-67.
58. Negrier S, Escudier B, Lasset C, et al. Recombinant interleukin-2, recombinant interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d0I mmunotherapie. N Eng J Med 1998, 338, 1272-1278.
59. Rini BI, Halabi S, Taylor J, et al. Cancer and Leukemia Group B 90206: a randomized phase III trial of interferon-a plus anti-vascular endothelial growth factor antibody (Bevacizumab) in metastatic renal cell carcinoma. Clin Cancer Res 2004, 10, 2584-2586.
60. Buendia MA, Paterlini P, Tiollais P, et al. Hepatocellular carcinoma: molecular aspects. In: Zuckerman AJ, Thomas CT (Eds.), Viral Hepatitis. Churchill Livingstone, London, 1998, pp. 179-200.
61. Mahoney FJ. Update on diagnosis, management, and prevention of hepatitis B virus infection. Clin Microbiol Rev 1999, 12, 351-366.
62. Brandis H, Köhler W, Eggers HJ, Pulverer G. Lehrbuch der Medizinischen Mikrobiologie 7. Gustav Fischer, Jena, 1994.
63. Galle PR, Hofmann J, Walczak H, et al. Involvement of the CD95 (APO-1/Fas) receptor and ligand in liver damage. J Exp Med 1995, 182, 1223-1230.
64. Lok ASF, Wu P-C, Lai C-L, et al. A controlled trial of interferon with or without prednisone priming for chronic hepatitis B. Gastroenterology 1992, 102, 2091-2097.
65. Di Bisceglie AM, Bergasa N, Fong T-L, et al. A randomized controlled trial of recombinant alpha interferon therapy for chronic hepatitis B. Am J Gastroenterol 1993, 88, 1887-1892.
66. Wong DK, Cheung AM, O'Rourke K, et al. Effect of alphainterferon treatment in patients with hepatitis B e antigenpositive chronic hepatitis B. Ann Intern Med 1993, 119, 312-323.
67. Brook MG, Karayiannis P, Thomas HC. Which patients with chronic hepatitis B virus infection will respond to alphainterferon therapy? Hepatology 1989, 10, 761-763.
68. Marcelin P, et al. Peginterferon Alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAgnegative chronic hepatitis B. N Engl J Med 2004, 351, 32-43.
69. Hadziyyannis SJ. Hepatitis B e antigen negative chronic hepatitis B: from clinical recognition to pathogenesis and treatment. Viral Hepatitis Rev 1995, 1, 7-15.
70. Lok ASF, McMahon BJ. Chronic Hepatitis B. Hepatolgy 2001, 34, 1225-1241.
71. Cooksley WEG, Piratvisuth T, Lee SD, et al. Peginterferon a-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepatitis 2003, 10, 298-305.
72. Multiple Sclerosis International Federation; www.msif.org/en/ms_the_disease/causes_of_ms.html; accessed 27 June 2005.
73. Deutsche Multiple Sklerose Gesellschaft; www.dmsg.de/index.php?kategorie=wasistms; accessed 27 June 2005.
74. National MS Society; www.nationalmssociety.org/Sourcebook-Epidemiology.asp; accessed 27 June 2005.
75. Oksenberg JR, Baranzi SE, Barcellos LF, et al. Multiple sclerosis: genomic rewards. J Neuroimmunol 2001, 113, 171-184.
76. Hunter SF, Hafler DA. Ubiquitous pathogens-links between infection and autoimmunity in MS? Neurology 2000, 55, 164-165.
77. Keegan BM, Noseworthy JH. Multiple sclerosis. Ann Rev Med 2002, 53, 285-302.
78. Cepok S, Zhou D, Srivastava R, et al. Identification of Epstein-Barr virus proteins as putative targets of the immune response in multiple sclerosis. J Clin Invest 2005, 115, 1352-1360
79. van Holten J, Plater-Zyberk C, Tak PP. Interferon-b for treatment of rheumatoid arthritis? Arthritis Res 2002, 4, 346-352.
80. Rizzetto M, Canese MG, Aric S, et al. Immunofluorescence detection of new antigen-antibody system (delta/anti-delta) associated to hepatitis B virus in liver and serum of HBsAg carriers. Gut 1977, 18, 997-1003.
81. Hoofnagle JH. Therapy of viral hepatitis. Digestion 1998, 59, 563-578.
82. Lai MMC. The molecular biology of hepatitis delta virus. Annu Rev Biochem 1995, 64, 259-286.
83. WHO; www.who.int/csr/disease/hepatitis/HepatitisD_whocdscsrncs2001_1.pdf; accessed 27 June 2005.
84. Örmeci N. Short-and long-term effects of treatment of chronic hepatitis B and delta virus by IFN. Fundam Clin Pharmacol 2003, 17, 651-658.
85. Hadziyannis SJ. Review: hepatitis delta. J Gastroenterol Hepatol 1997, 12, 289-298.
86. Lau DTY, Kleiner DE, Park Y, et al. Resolution of chronic delta hepatitis after 12 years of interferon alfa therapy. Gastroenterology 1999, 117, 1229-1233.
87. Thomas HC, Farci P, Shein R, et al. Inhibition of hepatitis delta virus replication by lymphoblastoid human alpha interferon. Prog Clin Biol Res 1987, 234, 277-290.
88. Hoofnagle JH, Mullen K, Peters M, et al. Treatment of chronic delta hepatitis with recombinant human alpha interferon. Prog Clin Biol Res 1987, 234, 291-298.
89. Farci P, Mandas A, Coiana A, et al. Treatment of chronic hepatitis D with interferon alfa-2a. N Engl J Med 1994, 330, 88-94.
90. Di Marco V, Giacchino R, Timitilli A, et al. Long-term interferon-a treatment of children with chronic hepatitis delta: a multicenter study. J Viral Hepat 1996, 3, 123-128.
91. Walsh K, Alexander GJM. Update on chronic viral hepatitis. Postgrad Med J 2001, 77, 498-505.
92. WHO; www.who.int/csr/disease/hepatitis/Hepc.pdf; accessed 27 June 2005.
93. Lo Re III V, Kostman JR. Management of chronic hepatitis C. Postgrad Med J 2005, 81, 376-382.
94. Hoofnagle J, Mullen K, Jones D. Treatment of chronic non-A, non-B hepatitis with recombinant human alpha-Interferon. N Engl J Med 1986, 315, 1575-1578.
95. Poynard T, Marcellin P, Lee SS, et al. Randomized trial of interferon alfa 2b plus ribavirin versus interferon alfa 2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. Lancet 1998, 352, 1426-1431.
96. hepatitis-c.de/ifn.htm; accessed 27 June 2005.
97. www.adis.com/files/hepC1-2-00.pdf; accessed 27 June 2005.
98. Katre NV. Immunogenicity of recombinant IL-2 modified by covalent attachment of polyethylene glycol. J Immunol 1990, 144, 209-213.
99. Avgerinos GC, Turner BG, Gorelick KJ, et al. Production and clinical development of a Hansenula polymorpha-derived PEGylated hirudin. Semin Thromb Hemost 2001, 27, 357-72.
100. Wong SF, Chan HO. Effects of a formulary change from granulocyte colony-stimulating factor to granulocytemacrophage colony-stimulating factor on outcomes in patients treated with myelosuppressive chemotherapy. Pharmacotherapy 2005, 25, 372-378.
101. Reddy KR, Wright TL, Pockros PJ, et al. Efficacy and safety of pegylated (40-kd) Interferon a-2a compared with Interferon a-2a in noncirrhotic patients with chronic hepatitis C. Hepatology 2001, 33, 433-438.
102. Lindsay KL, Trepo Ch, Heintges T, et al. A randomized, double-blind trial comparing pegylated Interferon alfa-2b to Interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001, 34, 395-403.
103. Hadziyannis SJ, Sette H Jr., Morgan TR, et al. Peginterferon-a2a and ribavirin combination therapy in chronic hepatitis C. Ann Intern Med 2004, 140, 346-355.
104. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002, 347, 975-982.
105. www.sjogrens.org; accessed 27 June 2005.
106. www.uspharmacist.com/oldformat.asp?url=newlook/files/Feat/interferons.ht m&pub_id=8&article_ id=731; accessed 27 June 2005.
107. www.igb.fraunhofer.de/WWW/Presse/bilder/download.bis2000/IGB_IFN-beta.jp g
108. www.igb.fraunhofer.de/WWW/Presse/Jahr/2003/download.en.doc/US06572853.pd f; accessed 27 June 2005.
109. [No authors listed]. Interferon beta-1A: new preparation. A short-term impact on the course of multiple sclerosis. Prescrire Int 1998, 37, 142-143.
110. www.avonex.com; accessed 27 June 2005.
111. Obert HJ, Pöhlau D. Beta-Interferon-Schwerpunkt Multiple Sklerose. Springer, Berlin, 1999.
112. Abdul-Ahad AK, Galazka AR, Revel M, et al. Incidence of antibodies to interferon-beta in patients treated with recombinant human interferon-beta 1a from mammalian cells. Cytokines Cell Mol Ther 1997, 3, 27-32.
113. Bertolotto A, Malucchi S, Sala A, et al. Differential effects of three interferon betas on neutralizing antibodies in patients with multiple sclerosis: a follow up study in an independent laboratory. J Neurol Neurosurg Psychiatry 2002, 73, 148-153.
114. www.isicr.org/newsletter/isicr4.2.pdf; accessed 28 June 2005.
115. Taniguchi T, Fujii-Kuriyama Y, Muramatsu M. Molecular cloning of human interferon cDNA. Proc Nat Acad Sci USA 1980, 77, 4003-4006.
116. Kirkwood J, Strawderman MH, Ernstoff MS, et al. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: The Eastern Cooperative Oncology Group Trial EST 1864. J Clin Oncol 1996, 14, 7-17.
117. Pehamberger H, Soyer HP, Steiner A, et al. Adjuvant interferon alfa-2a treatment in resected primary Stage II cutaneous melanoma. J Clin Oncol 1998, 16, 1425-1429.
118. Kirkwood J, Ibrahim J, Sondak V, et al. Hugh-and low-dose interferon alfa-2b in high-risk melanoma: First analysis of Intergroup Trial E1690/S9111/C9190. J Clin Oncol 2000, 18, 2444-2458.
119. Sung C, Nardelli B, Lafleur DW, et al. An IFN-b-albumin fusion protein that displays improved pharmaco-kinetic and pharmacodynamic properties in nonhuman primates. J Interferon Cytokine Res 2003, 23, 25-369.
120. Press releases Human Genome Sciences; www.hgsi.com; accessed 30 June 2005.
121. www.multiplemyeloma.org/about_myeloma/index.html; accessed 30 June 2005.
122. www.oncologychannel.com/nonhodgkins/generaltreatment.shtml bio; accessed 30 June 2005.
123. www.amarbio.com; accessed 1 July 2005.
124. www.flamel.com/techAndProd/medusa.shtml pipeline; available from Internet 2005 July 1.
125. www.hgsi.com/products/albuferon.html; accessed 1 July 2005.
126. www.serono.com; accessed 1 July 2005.
127. Tak PP, Hart BA, Kraan MC, et al. The effects of interferonbeta treatment on arthritis. Rheumatology 1999, 38, 362-369.
128. Konishi I, Horiike N, Michitaka K, et al. Renal transplant recipient with chronic hepatitis C who obtained sustained viral response after interferon-b therapy-case report. Intern Med 2004, 43, 931-934.
129. Festi D, Sandri L, Mazzella E, et al. Safety of Interferon-b treatment for chronic HCV hepatitis. World J Gastroenterol 2004, 10, 12-16.
130. Pellicano R, Palmas F, Cariti G, et al. Re-treatment with interferon-beta of patients with chronic hepatitis C virus infection. Eur J Gastroenterol Hepatol 2002, 14, 1377-1382.
131. Rizzetto M, Alberti A, Craxi A, et al. Open, multicenter, randomized, controlled trial to compare safety and efficacy of r-hIFN beta 1a alone or in combination with ribavirin in HCV naive patients. Dig Liver Dis 2003, 35 (Suppl), A14.
132. Biotechnology for multiple sclerosis-beta-interferon; www.bioimpact.org; accessed 2 July 2005.
133. The North American Study Group on Beta-Interferon 1b in Secondary progressive MS. Interferon-beta 1b in secondary progressive MS. Neurology 2004, 63, 1788-1795.
134. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of Interferon-beta 1a in secondary progressive MS. Neurology 2001, 56, 1496-1504.
135. Yong VW, Chabot S, Stuve O, et al. Interferon beta in the treatment of multiple sclerosis: mechanism of action. Neurology 1998, 51, 682-689.
136. Buckel P (Ed.). Recombinant Protein Drugs-Milestones in Drug Therapy. Birkhäuser, Basel, 2001.
137. Mandelli F, Avvisati G, Amadori S, et al. Maintenance treatment with recombinant interferon alfa 2b in patients with multiple myeloma responding to conventional induction chemotherapy. N Engl J Med 1990, 322, 1430-1434.
138. Ferlin-Bezombes M, Jourdan M, Liautard J, et al. IFN-a is a survival factor for human myeloma cells and reduces dexamethasone-induced apoptosis. J Immunol 1998, 161, 2692-2699.
139. Barlogie B, Shaughnessy J, Tricot G, et al. Treatment of multiple myeloma. Blood 2004, 103, 20-32.
140. Platanias LC. Mechanisms of type-1-and type-II-interferon mediated signaling. Nat Rev Immunol 2005, 5, 375-386.
141. Deininger M, Buchunger E, Druker BJ. The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood 2005, 105, 2640-2653.