Renal uptake and tolerability of a 2'-O-methoxyethyl modified antisense oligonucleotide (ISIS 113715) in monkey

Toxicology

Volumn 301, Issue 1-3, 2012, Pages 13-20

  Henry, Scott P ^a   Johnson, Mark ^b   Zanardi, Thomas A ^a   Fey, Robert ^a   Auyeung, Diana ^c   Lappin, Patrick B ^c   Levin, Arthur A ^a  

^a ISIS PHARMACEUTICALS   (United States)

^b MPI RESEARCH   (United States)

^c CHARLES RIVER LABORATORIES   (United States)

Author keywords

Monkey; Oligonucleotide; Pharmacokinetics; Renal; Toxicology

Indexed keywords

ACETYLGLUCOSAMINIDASE; BETA 2 MICROGLOBULIN; CREATININE; GLUCOSE; GLUTATHIONE TRANSFERASE ALPHA; ISIS 113715; OLIGONUCLEOTIDE;

ANIMAL CELL; ARTICLE; BASOPHIL; CELL DAMAGE; CELL FUNCTION; CELL GRANULE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CYTOPLASM; DRUG TOLERABILITY; GLOMERULUS FILTRATION RATE; GLUCOSE TOLERANCE TEST; HAPLORHINI; KIDNEY BLOOD FLOW; KIDNEY CORTEX; KIDNEY EPITHELIUM; KIDNEY FUNCTION; MALE; NONHUMAN; PRIORITY JOURNAL; TREATMENT DURATION; UREA NITROGEN BLOOD LEVEL; URINARY EXCRETION; URINE; WATER DEPRIVATION;

ANIMALS; BLOOD UREA NITROGEN; CREATININE; CYTOPLASM; DOSE-RESPONSE RELATIONSHIP, DRUG; EPITHELIAL CELLS; GLUCOSE; KIDNEY CORTEX; KIDNEY FUNCTION TESTS; KIDNEY TUBULES, PROXIMAL; MACACA FASCICULARIS; MALE; OLIGORIBONUCLEOTIDES; PROTEINS; TISSUE DISTRIBUTION;

MACACA FASCICULARIS;

EID: 84864811592     PISSN: 0300483X     EISSN: 18793185     Source Type: Journal    
DOI: 10.1016/j.tox.2012.06.005     Document Type: Article

References (27)

1. Bendele A., Seely J., Richey C., Sennello G., Shopp G. Short communication: renal tubular vacuolation in animals treated with polyethylene-glycol-conjugated proteins. Toxicol. Sci. 1998, 42:152-157.
2. Brown D.A., Kang S.H., Gryaznov S.M., DeDionisio L., Heidenreich O., Sullivan S., Xu X., Nerenberg M.I. Effect of phosphorothioate modification of oligodeoxynucleotides on specific protein binding. J. Biol. Chem. 1994, 269:26801-26805.
3. Butler M., Stecker K., Bennett C.F. Cellular distribution of phosphorothioate oligodeoxynucleotides in normal rodent tissues. Lab. Invest. 1997, 77:379-388.
4. Butler M., Stecker K., Bennett C.F. Histological localization of phosphorothioate oligodeoxynucleotides in normal rodent tissue. Nucleosides Nucleotides 1997, 16:1761-1764.
5. Christensen E.I., Nielsen S. Structural and functional features of protein handling in the kidney proximal tubule. Semin. Nephrol. 1991, 11:414-439.
6. Conover C.D., Linberg R., Gilbert C.W., Shum K.L., Shorr R.G. Effect of polyethylene glycol conjugated bovine hemoglobin in both top-load and exchange transfusion rat models. Artif. Organs 1997, 21:1066-1075.
7. Dunnett G.A. A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 1955, 50:1096-1121.
8. Geary R.S., Matson J., Levin A.A. A nonradioisotope biomedical assay for intact oligonucleotide and its chain-shortened metabolites used for determination of exposure and elimination half-life of antisense drugs in tissue. Anal. Biochem. 1999, 274:241-248.
9. Geary R.S., Mathison B., Ushiro-Watanabe T., Savides M.C., Henry S.P., Levin A.A. Second generation antisense oligonucleotide pharmacokinetics and mass balance following intravenous administration in rats. Society of Toxicology 2001, Oxford University Press, San Francisco, CA, p. 343.
10. Geary R.S., Ushiro-Watanabe T., Truong L., Freier S.M., Lesnik E.A., Sioufi N.B., Sasmor H., Manoharan M., Levin A.A. Pharmacokinetic properties of 2'-O-(2-methoxyethyl)-modified oligonucleotide analogs in rats. J. Pharmacol. Exp. Ther. 2001, 296:890-897.
11. Henry S.P., Bolte H., Auletta C., Kornbrust D.J. Evaluation of the toxicity of ISIS 2302, a phosphorothioate oligonucleotide, in a 4-week study in cynomolgus monkeys. Toxicology 1997, 120:145-155.
12. Henry S.P., Geary R.S., Yu R., Levin A.A. Drug properties of second-generation antisense oligonucleotides: how do they measure up to their predecessors?. Curr. Opin. Investig. Drugs 2001, 2:1444-1449.
13. Krotz A.H., Cole D.L., Ravikumar V.T. Synthesis of an antisense oligonucleotide targeted against C-raf kinase: efficient oligonucleotide synthesis without chlorinated solvents. Bioorg. Med. Chem. 1999, 7:435-439.
14. Laiken N.D., Fanestil D.D. Body fluids and renal function. Physiological Basis of Medical Practice 1985, 451-458. Williams and Williams. J.B. West (Ed.).
15. Levin A.A. A review of issues in the pharmacokinetics and toxicology of phosphorothioate antisense oligonucleotides. Biochim. Biophys. Acta 1999, 1489:69-84.
16. Merski J.A., Meyers M.C. Light- and electron-microscopic evaluation of renal tubular cell vacuolation induced by administration of nitrilotriacetate or sucrose. Food Chem. Toxicol. 1985, 23:923-930.
17. Milliken G.A., Johnson D.E. Designed Experiments 1992, Chapman & Hall, New York.
18. Monteith D.K., Geary R.S., Leeds J.M., Johnston J., Monia B.P., Levin A.A. Preclinical evaluation of the effects of a novel antisense compound targeting C-raf kinase in mice and monkeys. Toxicol. Sci. 1998, 46:365-375.
19. Monteith D.K., Horner M.J., Gillett N.A., Butler M., Geary R.S., Burckin T., Ushiro-Watanabe T., Levin A.A. Evaluation of the renal effects of an antisense phosphorothioate oligodeoxynucleotide in monkeys. Toxicol. Pathol. 1999, 27:307-317.
20. Oberbauer R., Schreiner G.F., Meyer T.W. Renal uptake of an 18-mer phosphorothioate oligonucleotide. Kidney Int. 1995, 48:1226-1232.
21. Rappaport J., Hanss B., Kopp J.B., Copeland T.D., Bruggeman L.A., Coffman T.M., Klotman P.E. Transport of phosphorothioate oligonucleotides in kidney: implications for molecular therapy. Kidney Int. 1995, 47:1462-1469.
22. Sawai K., Takenori M., Takakura Y., Hashida M. Renal disposition characteristics of oligonucleotides modified at terminal linkages in perfused rat kidney. Antisense Res. Dev. 1995, 5:279-287.
23. Sawai K., Mahato R.I., Oka Y., Takakura Y., Hashida M. Disposition of oligonucleotides in isolated perfused rat kidney: involvement of scavenger receptors in their renal uptake. J. Pharmacol. Exp. Ther. 1996, 279:284-290.
24. Smith H.W., Goldring W., Chais H., Ranger H.A., Bradley S.E. The application of saturation methods to the study of glomerular and tubular function in human kidney. The Kidney 1951, Oxford Press, New York, pp. 59-108.
25. Srinivasan S.K., Tewary H.K., Iversen P.L. Characterization of binding sites, extent of binding, and drug interactions of oligonucleotides with albumin. Antisense Res. Dev. 1995, 5:131-139.
26. Welch B.L. The significance of difference between two means when the population variances are unequal. Biometrika 1947, 29:350.
27. Yu R.Z., Geary R.S., Monteith D.K., Matson J., Truong L., Fitchett J., Levin A.A. Tissue disposition of a 2'-O-(2-methoxy) ethyl modified antisense oligonucleotides in monkeys. J. Pharm. Sci. 2004, 93:48-59.