Gastroenterology
Volume 133, Issue 5 , Pages 1414-1422 , November 2007

A Phase I Study of Visilizumab, a Humanized Anti-CD3 Monoclonal Antibody, in Severe Steroid-Refractory Ulcerative Colitis

  • Scott Plevy

      Affiliations

    • Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina
    • Corresponding Author InformationAddress requests for reprints to: Scott Plevy, MD, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, 103 Mason Farm Road, Campus Box 7032, 7341C MBRB, Chapel Hill, North Carolina 27599-7032. fax: (919) 843-6899.
    • ,
  • Bruce Salzberg

      Affiliations

    • Atlanta Gastroenterology Associates, Atlanta, Georgia
    • ,
  • Gert Van Assche

      Affiliations

    • Division of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium
    • ,
  • Miguel Regueiro

      Affiliations

    • Division of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
    • ,
  • Daniel Hommes

      Affiliations

    • Leiden University Medical Center, Leiden, The Netherlands
    • ,
  • William Sandborn

      Affiliations

    • Mayo Clinic, Rochester, Minnesota
    • ,
  • Stephen Hanauer

      Affiliations

    • Gastroenterology Clinic, University of Chicago Medical Center, Chicago, Illinois
    • ,
  • Stephan Targan

      Affiliations

    • Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California
    • ,
  • Lloyd Mayer

      Affiliations

    • Mount Sinai School of Medicine, New York, New York
    • ,
  • Uma Mahadevan

      Affiliations

    • Mt Zion Hospital, University of California, San Francisco, San Francisco, California
    • ,
  • Matthew Frankel

      Affiliations

    • PDL BioPharma, Inc, Fremont, California
    • ,
  • James Lowder

      Affiliations

    • PDL BioPharma, Inc, Fremont, California

Received 17 October 2006 ,Accepted 2 August 2007.

References 

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  2. Jarnerot G, Rolny P, Sandberg-Gertzen H. Intensive intravenous treatment of ulcerative colitis. Gastroenterology. 1985;89:1005–1013
  3. Jarnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005;128:1805–1811
  4. Lichtiger S, Present DH, Kornbluth A, et al. Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med. 1994;330:1841–1845
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  7. Truelove S, Jewell D. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974;1:1067–1070
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  10. Alegre M, Peterson L, Xu D, et al. Non-activating “humanized” anti-CD3 monoclonal antibody retains immunosuppressive properties in vivo, A. Transplantation. 1994;57:1537–1543
  11. Cole M, Stellrecht K, Shi J, et al. HuM291, a humanized anti-CD3 antibody, is immunosuppressive to T-cells while exhibiting reduced mitogenicity in vitro. Transplantation. 1999;68:563–571
  12. Chau L, Tso J, Melrose J, et al. HuM291(Nuvion), a humanized Fc receptor-nonbinding antibody against CD3, anergizes peripheral blood T-cells as partial agonist of the T-cell receptor. Transplantation. 2001;71:941–950
  13. Truelove SC, Witts LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J. 1955;2:1041–1048
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  16. MedDRA. The Medical Dictionary for Regulatory Activities (MedDRA). Assessed 2007. Available at: www.medramsso.com/MSSOWeb/index.htm.
  17. National Cancer Institute. Common Toxicity Criteria. Bethesda, MD: National Cancer Institute; 2006;
  18. Gross T, Loechelt B. Epstein-Barr virus associated disease following blood or marrow transplant. Pediatr Transplant. 2003;7:44–50
  19. Birkeland S, Hamilton-Dutoit S. Is posttransplant lymphoproliferative disorder (PTLD) caused by any specific immunosuppressive drug or by the transplantation per se?. Transplantation. 2003;76:984–988
  20. Sands B, Tremaine W, Sandborn W, et al. Infliximab in the treatment of severe, steroid-refractory ulcerative colitis: a pilot study. Inflamm Bowel Dis. 2001;7:83–88

 Supported by the sponsor, PDL BioPharma, Fremont, CA.

 The authors declare the following conflicts of interest: consultant, PDL BioPharma (S.P., G.V., M.R., D.H., W.S., S.H., S.T., L.M., U.M.); research support for clinical trial, PDL BioPharma (S.P., B.S., G.V., M.R., D.H., W.S., S.H., S.T., L.M., U.M.); speaker at continuing medical education symposia sponsored by PDL BioPharma (S.P., W.S., S.H., D.H.).

 ClinicalTrials.gov identifier: NCT00032305.

PII: S0016-5085(07)01491-6

doi: 10.1053/j.gastro.2007.08.035

Gastroenterology
Volume 133, Issue 5 , Pages 1414-1422 , November 2007

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