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Experience with Marketed Biotech Products: rt-PA

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From Clone to Clinic

Part of the book series: Developments in Biotherapy ((DIBI,volume 1))

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Abstract

Tissue-type plasminogen activator, a physiological protein which can be produced on large scale by recombinant DNA technology, has attracted great attention for the treatment of myocardial infarction. The molecule was cloned in 1982 and the FDA approval for treatment of acute myocardial infarction was obtained in 1987. Meanwhile, clinical experience with several thousands of patients has accumulated with t-PA as well as with streptokinase, its closest competitor. Although t-PA treatment shows a substantially higher recanalisation rate as compared to streptokinase, its relative effect on mortality remains to be further investigated.

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References

  1. De Wood, M.A., Spores, J., Notske, R., Lowell, T., Mouser, T., Burroughs, R., Golden, M.S. and Lang, H.T. (1980) ‘Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction’, N. Engl. J. Med. 303, 897–902.

    Article  Google Scholar 

  2. Reddy, K.N.N. (1980) ‘Mechanism of activaton of human plasminogen by streptokinase, in Kline, Reddy (eds.), Fibrinolysis, CRC Press, Boca Raton, pp. 71.

    Google Scholar 

  3. Verstraete, M., Vermylen, J., Amery, A. and Vermylen, C. (1966) ‘Thrombolytic therapy with streptokinase using a standard dosage scheme’, Brit. Med. J. 1, 454–456.

    Article  PubMed  CAS  Google Scholar 

  4. Smith, R.A.G., Dupe, R.J., English, P.D. and Green, J. (1981) ‘Fibrinolysis with acyl-enzymes: a new approach to thrombolytic therapy’, Nature 290, 505–508.

    Article  PubMed  CAS  Google Scholar 

  5. Hoylaerts, M., Rijken, D.C., Lijnen, H.R. and Collen, D. (1982) ‘Kinetics of the activation of plasminogen by human tissue plasminogen activator. Role of fibrin’, J. Biol. Chem. 257, 2912–2919.

    PubMed  CAS  Google Scholar 

  6. Lijnen, H.R., Zamarron, C., Blaber, M., Winkler, M.E. and Collen, D. (1986) ‘Activation of plasminogen by pro-urokinase. I. Mechanism’, J. Biol. Chem. 261, 1253–1258.

    PubMed  CAS  Google Scholar 

  7. Camiolo, S.M., Thorsen, S. and Astrup, T. (1971) ‘Fibrinogenolysis and fibrinolysis with tissue plasminogen activator, urokinase, streptokinase-activated human globulin and plasmin’, Proc. Soc. Exp. Biol. Med. 138, 277–280.

    PubMed  CAS  Google Scholar 

  8. Wallen, P. (1978) ‘Chemistry of plasminogen’ Davidson, Rowan, Samama, Desnoyers (eds.), Prog Chem Fibrinolysis Thrombolysis 3, Raven Press, New York, pp. 167–171.

    Google Scholar 

  9. Collen, D., Rijken, D.C., Van Damme, J. and Billiau, A. (1982) ‘Purification of human tissue-type plasminogen activator in centigram quantities from human melanoma cell culture fluid and its conditioning for use in vivo’, Thromb. Haemost. 48, 294–296.

    PubMed  CAS  Google Scholar 

  10. Rijken, D.C., Wijngaards, G., Zaal-De Jong, M. and Welbergen, J. (1979) ‘Purification and partial characterization of plasminogen activator from human uterine tissue’, Biochim. Biophys. Acta 580, 140–153.

    Article  PubMed  CAS  Google Scholar 

  11. Rijken, D.C. and Collen, D. (1981) ‘Purification and characterization of the plasminogen activator secreted by human melanoma cells in culture’, J. Biol. Chem. 256, 7035–7041.

    PubMed  CAS  Google Scholar 

  12. Weimar, W., Stibbe, J., Van Seyen, A.J., Billiau, A., De Somer, P., and Collen, D. (1981) ‘Specific lysis of an iliofemoral thrombus by administration of extrinsic (tissue-type) plasminogen activator’, Lancet 2, 1018–1020.

    Article  PubMed  CAS  Google Scholar 

  13. Pennica, D., Holmes, W.E., Kohr, W.J., Harkins, R.N., Vehar, G.A., Ward, C.A., Bennett, W.F., Yelverton, E., Seeburg, P.H., Heyneker, H.L., Goeddel, D.V. and Collen, D. (1983) ‘Cloning and expression of human tissue-type plasminogen activator cDNA in E. coli’, Nature 301, 214–221.

    Article  PubMed  CAS  Google Scholar 

  14. Collen, D., Lijnen, H.R., Todd, P.A. and Goa, K.L. (1989) ‘Tissue-type plasminogen activator: A review of its pharmacological and therapeutic use as a thrombolytic agent’, Drugs 38, 346–388

    Article  PubMed  CAS  Google Scholar 

  15. Chesebro, J.H., Knatterud, G., Roberts, R., Borer, J., Cohen, L.S., Dalen, J., Dodge, H.T., Francis, C.K., Hillis, D., Ludbrook, I.,Markis, J.E., Mueller, H., Passamani, E.R., Powers, E.R., Rao, A.K.,Robertson, T., Ross, A., Ryan, T.J., Sobel, B.E., Willerson, J., Williams, D.O., Zaret, B.L. and Braunwald, E. (1987) ‘Thrombolysis in myocardial infarction (TIMI) trial, Phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge’, Circulation 76, 142–154.

    Article  PubMed  CAS  Google Scholar 

  16. Verstraete, M., Bernard, R., Bory, M., Brower, R.W., Collen, D., de Bono, D.P., Erbel, R., Huhamnn, W., Lennane, R.J., Lubsen, J.,Mathey, D., Meyer, J., Michels, H.R., Rutsch, W., Schartl, M., Schmidt, W., Uebis, R. and von Essen, R. (1985) ‘Randomised trial of intravenous recombinant tissue-type plasminogen activator versus intravenous streptokinase in acute myocardial infarction’, Lancet 1, 842–847.

    Article  PubMed  CAS  Google Scholar 

  17. Kent, R.S., Batson, A.G. and Littejohn, J.K. (1989) ‘Thrombolytic efficacy of tissue-type plasminogen activator’, in S. Sherry, R. Schröder, C. Kluft and A.J. Six (eds.), Controversies in coronary thrombolysis, Current Medical Literature Ltd., London, pp. 3.

    Google Scholar 

  18. Wilcox, R.G., von der Lippe, G., Olsson, C.G., Jensen, G., Skene, A.M. and Hampton, J.R. (1988) ‘Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction. Anglo-Scandinavian Study of Early Thrombolysis (ASSET)’, Lancet 2, 525–530.

    Article  PubMed  CAS  Google Scholar 

  19. ISAM study group (1986) ‘A prospective trial of intravenous streptokinase in acute myocardial infarction (ISAM). Mortality, morbidity and infarct size at 21 days’, N. Eng. J. Med. 314, 1465–1471.

    Article  Google Scholar 

  20. GISSI (Gruppo Italiano per lo studio della streptochinasi nell’ infarto miocardico) (1986) ‘Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction’, Lancet 1, 397–402.

    Google Scholar 

  21. ISIS-2 (second international study of infarct survival) Collaborative Group (1988) ‘Randomized trial of intravenous streptokinase, and aspirin, both or neither among 17,187 cases of suspected acute myocardial infarction’, Lancet 2, 349–360.

    Google Scholar 

  22. Van de Werf, F. and Arnold, A.E.R. (1988) ‘Intravenous tissue plasminogen activator and size of infarct, left ventricular function, and survival in acute myocardial infarction’, Br. Med. J. 297, 1374–1379.

    Article  Google Scholar 

  23. White, H.D., Rivers, J.T., Maslowski, A.H., Ormiston, J.A., Takayama, M., Hart, H.H., Sharpe, D.N., Whitlock, R.M.L. and Norris, R.M. (1989) ‘Effect of intravenous streptokinase as compared with that of tissue plasminogen activator on left ventricular function after first myocardial infarction’, N. Engl. J. Med. 320, 817–821.

    Article  PubMed  CAS  Google Scholar 

  24. Magnani, B., for the PAIMS Investigators. (1989) ‘Plasminogen activator Italian multicenter study (PAIMS): comparison of intravenous recombinant single-chain human tissue-type plasminogen activator (rt-PA) with intravenous streptokinase in acute myocardial infarction’, J. Am. Coll. Cardiol. 13, 19–26.

    Article  PubMed  CAS  Google Scholar 

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Authors
  1. L. Nelles
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  2. D. Collen
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Editor information

Editors and Affiliations

  1. Faculty of Pharmacy, Department of Pharmaceutics, University of Utrecht, Croesestraat 79, Utrecht, 3522 AD, The Netherlands

    D. J. A. Crommelin (Professor of Pharmacology) (Professor of Pharmacology)

  2. TNO Primate Center, Rijswijk, P.O.Box 5815, 2280 HV, The Netherlands

    H. Schellekens (Senior Research Fellow) (Senior Research Fellow)

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© 1990 Springer Science+Business Media Dordrecht

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Nelles, L., Collen, D. (1990). Experience with Marketed Biotech Products: rt-PA. In: Crommelin, D.J.A., Schellekens, H. (eds) From Clone to Clinic. Developments in Biotherapy, vol 1. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-3780-5_26

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  • DOI: https://doi.org/10.1007/978-94-011-3780-5_26

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-5683-0

  • Online ISBN: 978-94-011-3780-5

  • eBook Packages: Springer Book Archive

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