Pharmacokinetic features, immunogenicity, and toxicity of B43(anti-CD19)-pokeweed antiviral protein immunotoxin in cynomolgus monkeys

Clinical Cancer Research

Volumn 3, Issue 3, 1997, Pages 325-337

  Uckun, Fatih M ^a,h   Yanishevski, Yuri ^c   Turner, Nilgün ^g   Waurzyniak, Barbara ^e   Messinger, Yoav ^a   Chelstrom, Lisa M ^e   Lisowski, Elizabeth A ^e   Ek, Onur ^a   Zeren, Tamer ^a   Wendorf, Heather ^e   Langlie, Mridula Chandan ^d   Irvin, James D ^f   Myers, Dorothea E ^d   Fuller, Gene B ^b   Evans, William ^c   Gunther, Roland ^a  

^a University of Minnesota   (United States)

^b Holloman AFB   (United States)

^c ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^d Alexander and Parker Corporation   (United States)

^e PARKER HUGHES INSTITUTE   (United States)

^f Texas State University   (United States)

^g RUTGERS UNIVERSITY   (United States)

^h UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOTOXIN; POKEWEED ANTIVIRUS PROTEIN;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG DISPOSITION; HYPOALBUMINEMIA; IMMUNOGENICITY; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY TUBULE NECROSIS; MALE; MONKEY; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; PROTEINURIA;

ANIMALS; ANTIGENS, CD19; ANTIVIRAL AGENTS; HUMANS; IMMUNOTOXINS; INJECTIONS, INTRAVENOUS; KIDNEY; KINETICS; MACACA FASCICULARIS; MICE; MODELS, BIOLOGICAL; N-GLYCOSYL HYDROLASES; PLANT PROTEINS; PROTEINURIA; RIBOSOME INACTIVATING PROTEINS, TYPE 1;

EID: 0030933719     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (43)

1. Trigg, M., Gaynon, P., and Uckun, F. M Acute lymphoblastic leukemia in children. In: J. F. Holland, R. C. Bast, D. L. Morton, E. Frei, D. W. Kufe, and R. R. Weichselbaum (eds.), Cancer Medicine, 4th ed., pp. 2945-2960, 1996.
2. Champlin, C. H., and Gale, R. P. Acute lymphoblastic leukemia: recent advances in biology and therapy. Blood, 73: 2051-2066, 1989.
3. Vitetta, E. S., Thorpe, P. F., and Uhr, J. W. Immunotoxins, Magic bullets or misguided missiles? Immunol. Today, 14: 252-259, 1993.
4. Uckun, F. M., and Reaman, G. H. Immunotoxins for treatment of leukemia and lymphoma. Leuk. & Lymphoma, 18: 195, 1995.
5. Grossbard, M. L., and Nadler, L. M. Immunotoxin therapy of lymphoid neoplasms. Semin. Hematol., 31: 88-97, 1994.
6. Uckun, F. M. Immunotoxins for the treatment of leukemia. Br. J. Haematol., 85: 435-438, 1993.
7. Amlot, P. L., Stone, M. J., Cunningham, D., Fay, J., Newman, J., Collins, R., May, R., McCarthy, M., Richardson, J., Ghetie, V., Ramilo, O., Thorpe, P. E., Uhr, J. W., and Vitetta, E. S. A Phase I study of an anti-CD22 deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood, 82: 2624-2633, 1993.
8. Vitetta, E. S., Stone, M., Amlot, P., Fay, J., May, R., Till, M., Newman, J., Clark, P., Collins, R., Cunningham, D., Ghetie, V., Uhr, J. W., and Thorpe, P. E. Phase I immunotoxin trial in patients with B-cell lymphoma. Cancer Res., 51: 4052-4058, 1991.
9. Sausville, E. A., Headlee, D., Stetler-Stevenson, M. Jaffe, E. S., Solomon, D., Tigg, W. D., Herdt, J., Kopp, W. C., Rager, H., Steinberg, S. M., and Vitetta, E. S. Continuous infusion of the anti-CD22 immunotoxin IgG-RFB4-SMPT-dgA in patients with B-cell lymphoma: a Phase I study. Blood, 55: 3457-3465, 1995.
10. Grossbard, M. L., Press, O. W., Appelbaum, F. R., Bernstein, I. D., and Nadler, L. M. Monoclonal antibody-based therapies of leukemia and lymphoma. Blood, 80: 863-878, 1992.
11. Uckun, F. M. Regulation of human B-cell ontogeny. Blood, 76: 1908-1923, 1990.
12. Uckun, F. M., Jaszcz, W., Ambrus, J. L., Fauci. A. S., GajlPeczalska, K. J., Song, C. W., Wick, M. R., Myers. D. E., Waddick, K. G., and Ledbetter, J. A. Detailed studies on expression and function of CD 19 surface determinant using B43 monoclonal antibody. Blood, 71: 13-29, 1988.
13. Irvin, J. D., and Uckun, F. M. Pokeweed antiviral protein: ribosome inactivation and therapeutic applications. Pharmacol. Ther, 55: 279-302, 1992.
14. Uckun, F. M., Gajl-Peczalska, K. J., Kersey, J. H., Houston, L. L., and Vallera, D. A. Use of a novel colony assay to evaluate the cytotoxicity of an immunotoxin containing pokeweed antiviral protein against blast progenitor cells freshly obtained from patients with common B-lineage acute lymphoblastic leukemia. J. Exp. Med., 163: 347-368, 1986.
15. Myers, D. E., Irvin, J. D., Smith, R. S., Kuebelbeck, V. M., and Uckun, F. M. Production of a pokeweed antiviral protein (PAP)-containing immunotoxin, B43-PAP, directed against the CD 19 human B-lineage lymphoid differentiation antigen in highly purified form for human clinical trials. J. Immunol. Methods, 36: 221-238, 1991.
16. Waddick, K. G., Gunther, R., Chelstrom, L. M., Chandan-Langlie, M., Myers, D. E., Irvin, J. D., Turner, N., and Uckun, F. M. In vitro and in vivo anti-leukemic activity of B43 (anti-CD 19)-pokeweed antiviral protein immunotoxin against radiation resistant human pre-B acute lymphoblastic leukemia cells. Blood, 86: 4228-4233, 1995.
17. Jansen, B., Uckun, F. M., Jaszcz, W. B., and Kersey, J. H. Establishment of a human t(4;ll) leukemia in SCID mice and successful treatment using anti-CD19 (B43)-pokeweed antiviral protein immunotoxin. Cancer Res., 52: 406-412, 1992.
18. Uckun, F. M., Manivel, C., Arthur, D., Chelstrom, L., Finnegan, D., Tuel-Ahlgren, L., Irvin, J. D., Myers, D. E., and Gunther, R. In vivo efficacy of B43 (anti-CD 19) pokeweed antiviral protein immunotoxin against human pre-B cell acute lymphoblastic leukemia in mice with severe combined immunodeficiency. Blood, 79: 2201-2214, 1992.
19. Uckun, F. M., Chelstrom, L. M., Finnegan, D., Tuel-Ahlgren, L., Irvin, J. D., Myers, D. E., and Gunther, R. Effective immunochemotherapy of CALLA+Cμ+ human pre-B acute lymphoblastic leukemia in mice with severe combined immunodeficiency using B43 (antiCD19) pokeweed antiviral protein (PAP) immunotoxin plus cyclophosphamide. Blood, 79: 3116-3129, 1992.
20. Uckun, F. M., Evans, W. E., Forsyth, C. J., Waddick, K. G., T-Ahlgren, L., Chelstrom, L. M., Burkhardt, A., Bolen, J., and Myers, D. E. Biotherapy of B-cell precursor leukemia by targeting genistein to CD19-associated tyrosine kinases. Science (Washington DC), 267: 886-891, 1995.
21. Gunther, R., Chelstrom, L. M., Wendorf, H. R., Schneider, E. A., Covalciuc, K., Johnson, B., Clementson, D., Irvin, J. D., Myers, D. E., and Uckun, F. M. Toxicity profile of the investigational biotherapeutic agent, B43 (anti-CD19)-pokeweed antiviral protein immunotoxin. Leuk. & Lymphoma, 22: 61-70, 1996.
22. Uckun, F. M., Myers, D. E., Irvin, J. D., Kuebelbeck, V. M., Finnegan, D., Chelstrom, L. M., and Houston, L. L. Effects of the intermolecular toxin-monoclonal antibody linkage on the in vivo stability, immunogenicity, and anti-leukemic activity of B43 (anti-CD 19) pokeweed antiviral protein immunotoxin. Leuk. & Lymphoma, 9: 459-476, 1993.
23. Myers, D. E., Yanishevski, Y., Masson, E., Irvin, J. D., Evans, W. E., and Uckun, F. M. Favorable pharmacodynamic features and superior antileukemic activity of B43 (anti-CD19J) immunotoxins containing two pokeweed antiviral protein molecules covalently linked to each monoclonal antibody molecule. Leuk. & Lymphoma, 18: 93-102, 1995.
24. D'Argenio, D. Z., and Schumitzky, A. A program package for simulation and parameter estimation in pharmacokinetics systems. Comput. Programs Biomed., 9: 115-134, 1979.
25. Yamaoka, K., Nakagawa, T., and Uno, T. Application of Akaike's information criterion (AIC) in the evaluation of linear pharmacokinetic equations. J. Pharmacokinet. Biopharm., 6: 165-175, 1978.
26. Uckun, F. M., Ramakrishnan, S., and Houston, L. L. Increased efficiency in selective elimination of leukemia cells by a combination of a stable derivative of cyclophosphamide and a human B cell specific immunotoxin containing pokeweed antiviral protein. Cancer Res., 45: 69-75, 1985.
27. Grossbard, M. L., and Nadler, L. M. Immunotoxin therapy of lymphoma. Cancer Treat. Res., 68: 111-131, 1993.
28. Laurent, G., Frankel, A. E., and Hertler, A. A. Treatment of leukemia patients with T101 ricin A chain immunotoxins. Cancer Treat. Rep., 37: 483-491, 1988.
29. Ghetie, M. A., and Vitetta, E. S. Recent developments in immunotoxin therapy. Curr. Opin. Immunol., 6: 707-716, 1994.
30. LeMaistre, C. F., Rosen, S., Frankel, A., Kornfeld, S., Sana, E., Meneghetti, C., Drajesk, J., Fishwild, D., Scannon, P. J., and Byers, V. S. Phase I trial of H65-RTA immunoconjugate in patients with cutaneous T-cell lymphoma. Blood, 78: 1173-1182, 1991.
31. Aron, G. M., and Irvin, J. D. Cytotoxicity of pokeweed antiviral protein. Cytobios, 55: 105-111, 1988.
32. Goldmacher, V. S., Tinnel, N. L., and Nelson, B. C. Evidence that pinocytosis in lymphoid cells has a low capacity. J. Cell Biol., 702: 1312-1319, 1986.
33. Silverstein, S. C., Steinman, R. M., and Conn, Z. A. Endocytosis. Annu. Rev. Biochem., 46: 669-722, 1977.
34. Steinman, R. M., Brodie, S. E., and Conn, Z. A. Membrane flow during pinocytosis. J. Cell Biol., 68: 665-687, 1976.
35. Besterman, J. M., Airhart, J. A., Woodworth, R. C., and Low, R. B. Exocytosis of pinocytosed fluid in cultured cells: kinetic evidence for rapid turnover and compartmentalization. J. Cell Biol., 91: 716-727, 1981.
36. Brown, M. S., Anderson, R. G., and Goldstein, J. L. Recycling receptors: the round trip itinerary of migrant membrane proteins. Cell, 32: 663-667, 1983.
37. Hur, Y., Hwang, D. J., Zoubenko, O., Coetzer, C., Uckun, F. M., and Turner, N. Isolation and characterization of pokeweed antiviral protein mutations in Saccharomyces cerevisiae: identification of residues important for toxicity. Proc. Natl. Acad. Sci. USA, 92: 8448-8452, 1995.
38. Uckun, F. M., Chelstrom, L. M., Irvin, J. D., Finnegan, D., Gunther, R., Young, J., Kuebelbeck, V., Myers, D. E., and Houston, L. L. In vivo efficacy of B43 (anti-CD 19)-pokeweed antiviral protein immunotoxin against BCL-1 murine B-cell leukemia. Blood, 79: 2649-2661, 1992.
39. Henry, R., Begent, J., and Pedley, R. B. Monoclonal antibody administration; current clinical pharmacokinetic status and future trends. Clin. Pharmacokinet., 23: 85-89, 1992.
40. Reilly, R. M., Sandhu, J., Alvarez-Diez, T. M., Gallinger, S., Kirsch, J., and Stern, H. Problems of delivery of monoclonal antibodies: pharmaceutical and pharmacokinetic solutions. Clin. Pharmacokinet., 28: 126-142, 1995.
41. Bocci, V. Metabolism of protein anticancer agents. In: G. Powis (ed.), Anticancer Drugs: Antimetabolite Metabolism and Natural Anticancer Agents, pp. 387-436. Pergamon Press, 1994.
42. Stute, N., Santana, V. M., Rodman, J. H., Schell, M. J., Ihle, J. N., and Evans, W. E. Pharmacokinetics of subcutaneous recombinant human granulocyte colony-stimulating factor in children. Blood, 79: 2849-2854, 1992.
43. Kuwabara, T., Kalo, Y., Kobayashi, S., Suzuki, H., and Sugiyama, Y. Nonlinear pharmacokinetics of a recombinant human granulocyte colony-stimulating factor derivative (nartograstim): species differences among rats, monkeys, and humans. J. Pharmacol. Exp. Ther., 277: 1535-1543, 1994.