Abstract
Following successful clinical trials by their Transplantation Multicenter Study Group in 1985, Ortho Pharmaceutical was grated a licence by the U.S. FDA the following year for routine administration of their OKT3 murine monoclonal antibody for the prevention of graft rejection in renal transplant patients. It is significant, however, that despite encouraging results from these and other clinical trials employing murine monoclonals produced in vitro or in mouse ascites for the treatment of various cancers (Herlyn and Koprowski, 1982; Miller et al., 1982 and 1983; Foon et al., 1984; Oldham et al., 1984; Sears et al., 1984) no further licences have since been awarded for their use in humans.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Beasley, R., Hivang, L., Levc, et al. (1981) Lancet 2, 388–393.
Boulianne, G. L., Hozumi, N., and Shulman, M. S. (1984) Nature 312, 643.
Boyd, J. E., and James K. (1989) Monoclonal Antibodies: Production and Application, pp. 1–43, Alan R. Liss, New York.
Brown, J., Whittle, H. C., Berzinz, K., Howard, R. J., Marsh, K., and Sjoberg, K. (1985) Clin. Exp. Immuno. 62.
Brown, J., (1989), in preparation.
Cabilly, S., Riggs, A., and Pande, H. (1984) Proc. Natl. Acad. Sci. USA 81, 3273–3277.
Carthew, P. (1986) J. Gen. Virol. 67, 963.
Crawford, D. H., Barlow, M. J., Mulholland, N., et al. (1984) Proc. Br. Blood Transfusion Soc. 1, 113–121.
Croce, C. M., Linnenbach, A., Hall, W., Setplewski, Z., and Koprowski, H. (1980) Nature 288, 488.
Foon, K., Schroff, R., Bunn, P., et al. (1984) Blood 64, 1085–1093.
Herlyn, D., and Koprowski, H. (1982) Proc. Natl. Acad. Sci. 47, 61–65.
Hojman, F., Emanoil-Ravier, R., Lesser, J., et al. (1988) Develop. Biol. Standard 70, 195–202.
Jeffreys, A. J., Wilson, V., and Thein, S. L. (1985) Nature 314, 67–73.
Jones, P. T., Dear, P. H., Foote, J., Neuberger, M. S., and Winter, G. (1986) Nature 321, 522.
Kohler, G., and Milstein, C. (1975) Nature 256, 495.
Kozbor, D., Lagarde, A. E., and Roder, V. C. (1982) Proc. Natl. Acad. Sci. USA 79, 6651.
Larrick, J. W., Dyer, B. J., Senyk, G., et al. (1985) p. 149, Plenum Press, New York.
Lundgren, K., Wahlgren, M., Troye-Blomberg, M., Berzins, K., Perlmann, H., and Perlmann, P. (1983) J. Immunol. 131, 2000.
Liu, A. Y., Robino, R. R., and Hellström, K. E. (1987) Proc. Natl. Acad. Sci. USA 84, 3439.
Lubienecki, A. S., Dinowitz, M., Nelson, et al. (1988) Develop. Biol. Standard 70, 187–191.
Macdonald, G., Primrose, S., Biggins, K., et al. (1987); Scand. J. Immunol. 25, 477.
Marcus-Sekura, C. J., Klutch, M., Lundquist, M., et al. (1988) Develop. Biol. Standard 70, 193–194.
Miller, R., Maloney, D., Warnke, R., and Levy, R. (1982) New Engl. Med. J. 306, 517–522.
Neuberger, M. S. (1985) Trends Biotechnol. 3, 347.
Nishimura, Y., Yokoyama, M., Araki, K., et al. (1987) Cancer Res. 47, 999.
Oldham, R., Thurman, G., Talmadge, J., Stevenson, H., and Foon, K. (1984) Cancer 54, 2795–2806.
Onions, D. E., (1989) Personal Communication.
Ortho Multicentre Transplant Group (1985) New Engl. Med. J. 313, 337–342.
Parker, J. C., Tennent, R. W., Ward, T. G., Rowe, W. P. (1965) J. Natl. Cancer Inst. 34, 371–380.
Peterson, W. D., Jr., Simpson, W. F., and Hakkv, B. (1979) Methods in Enzymology 58, 164–178.
Peterson, W. D., Jr., Ottenbreit, M. J. and Hakkv, B. (1984) Uses and Standardiszation of Vertebrate cultures 5, 116–224.
Sahagan, B. G., Dorai, H., Saltzgaber-Muller, J., et al. (1986), J. Immunol. 137, 1066.
Sears, H., Herlyn, D., Steplewski, Z., and Kiprowski, H. (1984) Biol. Response Mod. 3, 138–150.
Sun, L. K., Curtis, P., Rakowicz-Szulczynska, E., et al. (1987) Proc. Natl. Acad. Sci. USA 84, 214.
Tiebout, R. F., Striekcr, E. A. M., Oosterhof, F., et al. (1985) Scand. J. Immunol. 22, 691.
Weiss, R. A. (1982) Immunol. Today 3, 292.
Wiebe, M. E., Becker, F., Lazar, R., et al. (1989) Develop. Biol. Standard 70, 147.
Yoshikawa, K., Veda, R., Obata, Y., et al. (1986) Jpn. Cancer Res. 77, 1122.
Editor information
Copyright information
© 1990 Stockton Press
About this chapter
Cite this chapter
Brown, J. (1990). Therapeutic Monoclonal Antibodies: European Regulatory Issues. In: Borrebaeck, C.A.K., Larrick, J.W. (eds) Therapeutic Monoclonal Antibodies. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-11894-6_20
Download citation
DOI: https://doi.org/10.1007/978-1-349-11894-6_20
Publisher Name: Palgrave Macmillan, London
Print ISBN: 978-1-349-11896-0
Online ISBN: 978-1-349-11894-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)