Evaluation of the Renal Effects of an Antisense Phosphorothioate Oligodeoxynucleotide in Monkeys

Toxicologic Pathology

Volumn 27, Issue 3, 1999, Pages 307-317

  Monteith, David K ^a   Horner, Michelle J ^a   Gillett, Nancy A ^a   Butler, Madeline ^b   Geary, Richard ^b   Burckin, Todd ^b   Ushiro Watanabe, Tanya ^b   Levin, Arthur A ^b  

^a CHARLES RIVER LABORATORIES   (United States)

^b ISIS PHARMACEUTICALS   (United States)

Author keywords

Kidney toxicity; nephrotoxicity; oligonucleotide; primate renal function

Indexed keywords

AFOVIRSEN; ANTISENSE OLIGODEOXYNUCLEOTIDE; CREATININE; OLIGODEOXYNUCLEOTIDE PHOSPHOROTHIOATE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; FEMALE; HISTOPATHOLOGY; IMMUNOHISTOCHEMISTRY; MALE; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; RHESUS MONKEY; SUBCUTANEOUS DRUG ADMINISTRATION; TISSUE DEGENERATION; URINALYSIS;

ANIMALS; ANTIVIRAL AGENTS; BODY WEIGHT; CREATININE; CYTOPLASMIC GRANULES; DRUG EVALUATION; EATING; FEMALE; IMMUNOENZYME TECHNIQUES; KIDNEY; KIDNEY DISEASES; KIDNEY TUBULES, PROXIMAL; LIVER; MACACA MULATTA; MALE; OLIGONUCLEOTIDES, ANTISENSE; PROTEINURIA; THIONUCLEOTIDES;

ANIMALIA; MACACA MULATTA; PRIMATES;

EID: 0033060190     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339902700306     Document Type: Article

References (24)

1. Agrawal S., Zhang X., Lu Z., Zhao H., Tamburin JM, Yan J., Cai H., Diasio RG, Habus I., Jlang Z., Iyer RP, Yu D., and Zhang R. (1995). Absorption, tissue distribution and in vivo stability in rats of a hybrid antisense oligonucleotide following oral administration. Biochem. Pharmacol. 50: 571-576.
2. Butler M., Stecker K., and Bennett CF (1997). Cellular distribution of phosphorothioate oligodeoxynucleotides in normal rodent tissues. Lab. Invest. 77: 379-388.
3. Christensen EI and Nielsen S. (1991). Structural and functional features of protein handling in the kidney proximal tubule. Semin. Nephrol. 11: 414-439.
4. Cossum PA, Sasmor H., Dellinger D., Truong L., Cummins L., Owens SR, Markham PM, Shea JP, and Crooke ST (1993). Disposition of the 14C-labeled phosphorothioate oligonucleotide ISIS 2105 after intravenous administration to rats. J. Pharmacol. Exp. Ther. 267: 1181-1190.
5. Cossum PA, Troung L., Owens SR, Markham PM, Shea JP, and Crooke ST (1994). Pharmacokinetics of a 14C-labeled phosphorothioate oligonucleotide, ISIS 2105, after intradermal administration to rats. J. Pharmacol. Exp. Ther. 269: 89-94.
6. Crooke ST, Graham MJ, Zuckerman JE, Brooks D., Conklin BS, Cummins LL, Greig MJ, Guinosso CJ, Kornbrust D., Manoharan M., Sasmor HM, Schleich T., Tivel KL, and Griffey RH (1996). Pharmacokinetic properties of several novel oligonucleotide analogs in mice. J. Pharmacol. Exp. Ther. 277: 923-937.
7. Dahl DC, Tsao T., and Rabkin R. (1990). Alternative pathways for the renal processing of insulin. Contrib. Nephrol. 83: 53-59.
8. Galbraith WM, Hobson WC, Giclas PC, Schechter PJ, and Agrawal S. (1994). Complement activation and hemodynamic changes following intravenous administration of phosphorothioate oligonucleotides in the monkey. Antisense Res. Dev. 4: 201-206.
9. Geary RS, Leeds JM, Fitchett J., Burckin T., Troung L., Spainhour C., Creek M., and Levin AA (1997). Pharmacokinetics and metabolism in mice of a phosphorothioate oligonucleotide antisense inhibitor of C-raf-1 kinase expression. Drug Metabol. Dispos. 25: 1272-1281.
10. Geary RS, Leeds JM, Henry SP, Monteith DM, and Levin AA (1997). Antisense oligonucleotide inhibitors for the treatment of cancer. 1. Pharmacokinetic properties of phosphorothioate oligodeoxynucleotides. Anti-Cancer Drug Design 12: 383-394.
11. Henry SP, Bolte H., Auletta C., and Kornbrust DJ (1997). Evaluation of the toxicity of ISIS 2302, a phosphorothioate oligonucleotide, in a 4-week study in cynomolgus monkeys. Toxicology 120: 145-155.
12. Henry SP, Monteith D., and Levin AA (1997). Antisense oligonucleotide inhibitors for the treatment of cancer. 2. Toxicologic properties of phosphorothioate oligodeoxynucleotides. Anti-Cancer Drug Design 12: 395-408.
13. Leeds JM, Graham MJ, Truong L., and Cummins LL (1996). Quantitation of phosphorothioate oligonucleotides in human plasma. Anal. Biochem. 235: 36-43.
14. Maruhn D. (1976). Rapid colorimetric assay of β-glacatosidase and N-acetyl-β-glucosaminidase in human urine. Clin. Chem. ACTA 73: 453-461.
15. Oberbauer R., Schreiner GF, and Meyer TW (1995). Renal uptake of an 18-mer phosphorothioate oligonucleotide. Kidney Int. 48: 1226-1232.
16. Phillips JA, Craig SJ, Bayley D., Christian RA, Geary R., and Nicklin PL (1997). Pharmacokinetics, metabolism and elimination of a 20-mer phosphorothioate oligodeoxynucleotide (CGP 69846A) after intravenous and subcutaneous administration. Biochem. Pharmacol. 54: 657-668.
17. Plenat F., Klein-Monhoven N., Marie B., Vignaud J-M., and Duprez A. (1995). Cell and tissue distribution of synthetic oligonucleotides in healthy and tumor-bearing nude mice. Am. J. Pathol. 147: 124-135.
18. Rappaport J., Hanss B., Kopp JB, Copeland TD, Bruggeman LA, Coffman TM, and Klotman PE (1995). Transport of phosphorothioate oligonucleotides in kidney: Implications for molecular therapy. Kidney Int. 47: 1462-1469.
19. Sands H., Gorey-Feret LJ, Cocuzza AJ, Hobbs FW, Chidester D., and Trainor GL (1994). Biodistribution and metabolism of internally 3H-labeled oligonucleotides. I. Comparison of a phosphodiester and phosphorothioate. Mol. Pharmacol. 45: 932-943.
20. Sarmiento UM, Perez JR, Becker JM, and Ramaswamy N. (1994). In vivo toxicological effects of rel A antisense phosphorothioates in CD-1 mice. Antisense Res. Dev. 4: 99-107.
21. Sawai K., Mahato RI, Oka Y., Takakura Y., and Hashida M. (1996). Disposition of oligonucleotides in isolated perfused rat kidney: Involvement of scavenger receptors in their renal uptake. J. Pharmacol. Exp. Ther. 279: 284-290.
22. Sawai K., Takenori M., Takakura Y., and Hashida M. (1995). Renal disposition characteristics of oligonucleotides modified at terminal linkages in perfused rat kidney. Antisense Res. Dev. 5: 279-287.
23. Srinivasan SK and Iversen P. (1995). Review of in vivo pharmacokinetics and toxicology of phosphorothioate oligonucleotides. J. Clin. Lab. Anal. 9: 129-137.
24. Zhang R., Diasio RB, Lu Z., Liu T., Jiang Z., Galbraith WM, and Agrawal S. (1995). Pharmacokinetics and tissue distribution in rats of an oligodeoxynucleotide phosphorothioate (Gem 91) developed as a therapeutic agent for human immunodeficiency virus type-1. Biochem. Pharmacol. 49: 929-939.