Fomivirsen – a phosphorothioate oligonucleotide for the treatment of CMV retinitis

Ocular Immunology and Inflammation

Volumn 7, Issue 42067, 1999, Pages 189-198

  de Smet, Marc D ^a   Meenken, Christina ^a   Van Den Horn, Gerardus J ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; FOMIVIRSEN;

CATARACT; CLINICAL TRIAL; CONFERENCE PAPER; CYTOMEGALOVIRUS INFECTION; DRUG CLEARANCE; DRUG HALF LIFE; DRUG MECHANISM; HUMAN; INTRAOCULAR HYPERTENSION; NONHUMAN; RABBIT; RETINITIS; UVEITIS; VIRUS INHIBITION; VITREOUS DISEASE;

ANTIVIRAL AGENTS; CLINICAL TRIALS, PHASE III; CYTOMEGALOVIRUS INFECTIONS; DISEASE PROGRESSION; EYE; HUMANS; OLIGONUCLEOTIDES, ANTISENSE; RETINITIS; THIONUCLEOTIDES; TIME FACTORS;

EID: 0033379680     PISSN: 09273948     EISSN: 17445078     Source Type: Journal    
DOI: 10.1076/ocii.7.3.189.4007     Document Type: Article

References (39)

1. Zamecnik PC, Stephenson ML. Inhibition of Rous sarcoma virus replication and cell transformation by a specific oligodeoxynucleotide. Proc Natl Acad Sci USA 1978; 75: 280 – 284.
2. Mirabelli CK, Crooke ST. Antisense oligonucleotides in the context of modern molecular drug discovery and development. In: Crooke ST, Lebleu B, Crooke ST, Lebleu BS, editors. Antisense Research and Applications. Boca Raton: CRC Press, 1993; 7 – 35.
3. Anderson KP, Fox MC, Brown-Driver V, Martin MJ, Azad RF. Inhibition of human cytomegalovirus immediate-early gene expression by an antisense oligonucleotide complementary to immediate-early RNA. Antimicrob Agents Chemother 1996 40: 2004. -2011.
4. Azad RF, Driver VB, Tanaka K, Crooke RM, Anderson KP. Antiviral activity of a phosphorothioate oligonucleotide complementary to RNA of the human cytomegalovirus major immediate-early region. Antimicrob Agents Chemother 1993; 37: 1945 – 1954.
5. Southern EM, Milner N, Mir KU.Discovering antisense reagents by hybridization of RNA to oligonucleotide arrays. In: Chadwick DJ, Cardew G, editors. Oligonucle-otides as Therapeutic Agents. Ciba Foundation Symposium 209. Chichester: John Wiley & Sons, 1997; 38 – 46.
6. Southern EM, Case-Green SC, Elder JK, et al. Arrays of complementary oligonucleotides for analysing the hybridisation behaviour of nucleic acid. Nucleic Acids Res 1994; 22: 1368 – 1373.
7. Wyatt JR, Vickers TA, Roberson JL, et al. Combinatorially selected gyanosine-quartet structure is a potent inhibitor of human immunodeficiency virus envelope-mediated cell fusion. Proc Natl Acad Sci USA 1994; 91: 1356 – 1360.
8. Gao WY, Hanes RN, Vazquez-Padua MA, Stein CA, Cohen JS, Cheng YC. Inhibition of herpes simplex virus type 2 growth by phosphorothioate oligodeoxynucleotides. Antimicrob Agents Chemother 1990; 34: 808 – 812.
9. Gao W, Stein CA, Cohen JS, Dutschman GE, Cheng YC. Effect of phosphorothioate homo-oligodeoxynucleotides on herpes simplex virus type 2-induced DNA polymerase. J Biol Chem 1989;264: 11521 – 11526.
10. Crooke ST, Bennett CF. Progress in antisense oligonucleotide therapeutics. Annu Rev Pharmacol Toxicol 1996; 36: 107 – 129.
11. Crooke ST, Grillone LR, Tendolkar A, et al. A pharmacokinetic evaluation of '4C-labelled afovirsen sodium in patients with genital warts. Clin Pharmacol Ther 1994; 277: 641 – 646.
12. Crooke ST. Progress in antisense therapeutics discovery and development. In: Chadwick DJ, Cardew G, editors. Oligonucleotides as Therapeutic Agents. Ciba Foundation Symposium 209. Chichester: John Wiley & Sons, 1997; 158 – 168.
13. Crooke ST. Basic principles of antisense therapeutics. In: Crooke ST, Crooke STs. Antisense research and application. Berlin: Springer-Verlag, 1998; 1 – 50.
14. De Clercq E, Eckstein F, Merigan TC. Interferon induction increased through chemical modification of synthetic polyribonuclotide. Science 1969; 165: 1137 – 1139.
15. Cook PD. Antisense medicinal chemistry. In: Crooke ST, Crooke STS, editors. Antisense Research and Application. Berlin: Springer-Verlag, 1998; 51 – 101.
16. Cossum PA, Sasmor H, Dellinger D, et al. Disposition of the '4C-labeled phosphorothioate oligonucleotide ISIS 2105 after intravenous administration to rats. J Pharmacol Exp Ther 1993; 267: 1181 – 1190.
17. Nicklin PL, Craig SJ, Phillips JA. Pharmacokinetic properties of phosphorothioates in animals — ab-sorption, distribution, metabolism and elimination. In: Crooke ST, Crooke STS, editors. Antisense Research and Application. Berlin: Springer-Verlag, 1998; 141 – 168.
18. Levin AA, Monteith DK, Leeds JM, et al. Toxicity of oligonucleotide therapeutic agents. In: Crooke ST, Crooke STS, editors. Antisense Research and Application. Berlin: Springer-Verlag, 1998; 169 – 215.
19. Henry SP, Grillone LR, On JL, Bruner RH, Kornbrust DJ. Comparison of the toxicity profiles of ISIS 1082 and ISIS 2105, phophorothioate oligonucleotides, following subacute intradermal administration in Sprague-Dawley rats. Toxicology 1997; 116: 77 – 88.
20. Henry SP, Taylor J, Midgley L, Levin AA, Kornbrust DJ. Evaluation of the toxicity of ISIS 2302, a phospho-rothioate oligonucleotide, in a 4-week study in CD-, mice. Antisense Nucleic Acid Drug Dev 1997; 7: 473 – 481.
21. Klinman DM, AE-Kyung Y, Beaucage SL, Conover J, Krieg AM. CpG motifs present in bacterial DNA rapidly induce lymphocytes to secrete interleukin 6, interleukin 12, and interferon y. Proc Natl Acad Sci USA 1996; 93: 2879 – 2883.
22. Crooke RM, Crooke ST, Graham MJ, Cooke ME. Effect of antisense oligonucleotides on cytokine release from human keratinocytes in an in vitro model of skin. Toxicol Appl Pharmacol 1996; 140: 85 – 93.
23. Krieg AM, Yi A-K, Matson S, et al. CpG motifs in bacterial DNA trigger direct B-cell activation. Nature 1995; 374: 546 – 549.
24. Yamamoto T, Yamamoto S, Kataoka T, Tokunaga T. Ability of oligonucleotides with certain palindromes to induce interferon production and augment natural killer cell activity is associated with their base length. Antisense Res Dev 1994; 4: 119 – 122.
25. Stacey ICJ, Sweet MJ, Hume DA. Macrophages ingest and are activated by bacterial DNA. J Immunol 1996; 157: 2116 – 2122.
26. Cowdery JS, Chace JH, Yi AK, Krieg AM. Bacterial DNA induces NK cells to produce IFN-y in vivo and increases the toxicity of lipopolysaccharides. J Immunol 1996;156:457 o–4575.
27. Krieg AM. Immune stimulation by oligonucleotides. In: Crooke ST, Crooke STS, editors. Antisense Research and Applications. Berlin: Springer-Verlag, 1998; 243 – 262.
28. Hartmann G, Krug A, Waller-Fontaine K, Endres S. Oligodeoxynucleotides enhance lipopolysaccharide-stimulated synthesis of tumor necrosis factor: dependence on phosphorothioate modification and reversal by heparin. Mol Med 1996; 2: 429 – 438.
29. Detrick B, Keller J, Hooks JJ, Nagineni C, Anderson K, Henry S. Characterization of inhibition of CMV replication by fomivirsen, CMV antisense oligonucleotide. Invest Ophthalmol Vis Sci 1998; 39 (4): B661.
30. Anderson KP, Azad RF, Zhang H, Hofman J, Miner R, Drew WL. Growth inhibition of clinical and drugresistant isolates of human cytomegalovirus by the antisense phosphorothiate oligonucleotide, ISIS 2922. Antiviral Res 1996
31. Azad RF, Brown-Driver V, Buckheit RW Jr, Anderson KP. Antiviral activity of a phosphorothioate oligonucleotide complementary to human cytomegalovirus RNA when used in combination with antiviral nucleoside analogs. Antiviral Res 1995; 28: 101 – 111.
32. Leeds JM, Henry SP, Truong L, Zutshi A, Levin AA, Kornbrust D. Pharmacokinetics of a potential human cytomegalovirus therapeutic, a phosphorothioate oligonucleotide, after intravitreal injection in the rabbit. Drug Metab Dispos 1997; 25: 921 – 926.
33. Leeds JM, Henry SP, Bistner S, Scherrill S, Williams K, Levin AA. Pharmacokinetics of an antisense oligonucleotide injected intravitreally in monkeys. Drug Metab Dispos 1998; 26: 670 – 675.
34. Bejanian M, Lieberman RM, Goldstein, DA, Engstrom RE, Boyer DS, Dunn JP and the Fomivirsen Pharmacokinetics Study Group. A pharmacokinetic study of intravitreal fomivirsen (Vitravene) in patients with CMVR. Invest Ophthalmol Vis Sci 1999: 40 (4): S874.
35. Cochereau-Massin I, LeHoang P, Lautier-Frau M, et al. Efficacy and tolerance of intravitreal ganciclovir in cytomegalovirus retinitis in acquired immune deficiency syndrome. Ophthalmology 1991; 98: 1348 – 1355.
36. Tornambe PE. Pneumatic retinopexy. Surv Ophthalmol 1988; 32: 270 – 281.
37. Palestine AG, Polis MA, de Smet MD, et al. A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS. Ann Intern Med 1991; 115: 665 – 673.
38. Lieberman RM, Grillone LR, Chandler JW and the Fomivirsen Clinical Trials Investigators Group. Safety profile of low (3.0 mg/ml) and high (6.6 mg/ml) dose fomivirsen for the treatment of CMV retinitis. 12th World AIDS Conference. Geneva, June 1998; 1670.
39. Boyer DS, Muccioli C, Lieberman RM, Goldstein DA and the Fomivirsen Clinical Trials Investigators Group. Phase 3 results of the efficacy and safety of fomivirsen in the treatment of CMV retinitis (CMVR). American Academy of Ophthalmology. New Orleans, November 1998: 167.