Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Monoclonal antibody or fragment thereof
Reexamination Certificate
1998-03-12
2001-02-06
Johnson, Nancy A. (Department: 1642)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Monoclonal antibody or fragment thereof
C424S130100, C424S133100, C424S134100, C424S136100, C424S138100, C424S144100, C424S152100, C424S155100, C424S156100, C424S174100, C424S178100, C424S181100, C424S183100, C530S350000, C530S386000, C530S387100, C530S387300, C530S387700, C530S388100, C530S388150, C530S388200
Reexamination Certificate
active
06183744
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to immunotherapeutic methods for treating B-cell malignancies. In particular, this invention is directed to methods for treating B-cell malignancies by administering comparatively low doses of antibody that binds to the CD22 antigen. The present invention also is directed to multimodal therapeutic methods in which anti-CD22 administration is supplemented with chemotherapy, or by administration of therapeutic proteins, such as immunoconjugates and antibody fusion proteins.
2. Background
B-Cell lymphomas, such as the B-cell subtype of non-Hodgkin's lymphoma, are significant contributors to cancer mortality. The response of B-cell malignancies to various forms of treatment is mixed. For example, in cases in which adequate clinical staging of non-Hodgkin's lymphoma is possible, field radiation therapy can provide satisfactory treatment. Still, about one-half of the patients die from the disease. Devesa et al.,
J. Nat'l Cancer Inst.
79:701 (1987).
The majority of chronic lymphocytic leukemias are of B-cell lineage. Freedman,
Hematol. Oncol. Clin. North Am.
4:405 (1990). This type of B-cell malignancy is the most common leukemia in the Western world. Goodman et al.,
Leukemia and Lymphoma
22:1 (1996). The natural history of chronic lymphocytic leukemia falls into several phases. In the early phase, chronic lymphocytic leukemia is an indolent disease, characterized by the accumulation of small mature functionally-incompetent malignant B-cells having a lengthened life span. Eventually, the doubling time of the malignant B-cells decreases and patients become increasingly symptomatic. While treatment can provide symptomatic relief, the overall survival of the patients is only minimally affected. The late stages of chronic lymphocytic leukemia are characterized by significant anemia and/or thrombocytopenia. At this point, the median survival is less than two years. Foon et al.,
Annals Int. Medicine
113:525 (1990). Due to the very low rate of cellular proliferation, chronic lymphocytic leukemia is resistant to treatment.
Traditional methods of treating B-cell malignancies, including chemotherapy and radiotherapy, have limited utility due to toxic side effects. The use of monoclonal antibodies to direct radionuclides, toxins, or other therapeutic agents offers the possibility that such agents can be delivered selectively to tumor sites, thus limiting toxicity to normal tissues.
Antibodies against the CD20 antigen have been investigated for the therapy of B-cell lymphomas. For example, a chimeric anti-CD20 antibody, designated as “IDEC-C2B8,” has activity against B-cell lymphomas when provided as unconjugated antibodies at repeated injections of doses exceeding 500 mg per injection. Maloney et al.,
Blood
84:2457 (1994); Longo,
Curr. Opin. Oncol.
8:353 (1996). About 50 percent of non-Hodgkin's patients, having the low-grade indolent form, treated with this regimen showed responses. Therapeutic responses have also been obtained using
131
I-labeled B1 anti-CD-20 murine monoclonal antibody when provided as repeated doses exceeding 600 mg per injection. Kaminski et al.,
N. Engl. J. Med.
329:459 (1993); Press et al.,
N. Engl. J. Med.
329:1219 (1993); Press et al.,
Lancet
346:336 (1995). However, these antibodies, whether provided as unconjugated forms or radiolabeled forms, have not shown objective responses in patients with the more prevalent and lethal form of B-cell lymphoma, the intermediate or aggressive type.
Therefore, a need exists to develop an immunotherapy for B-cell malignancies that allows repeated administration of comparatively low doses of an antibody, and that is not limited by the necessity of adding a toxic agent for achieving a therapeutic response of significant duration.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a method for treating B-cell malignancies using comparatively low doses of anti-CD22 antibodies.
It is a further object of this invention to provide multimodal methods for treatment of B-cell malignancies in which low doses of anti-CD22 antibodies are supplemented with the administration of a therapeutic protein, such as an immunoconjugate or antibody fusion protein, or by a chemotherapeutic regimen.
These and other objects are achieved, in accordance with one embodiment of the present invention, by the provision of a method of treating a B-cell malignancy, comprising the step of administering to a subject having a B-cell malignancy an anti-CD22 antibody and a pharmaceutically acceptable carrier.
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Grossbard et al. “Monoclonal Antibody-Based Therapies of Leukemia and Lymphoma”Blood, vol. 80, No. 4 (Aug. 15), 1992: pp 863-878.
Juweid et al. “Treatment of Non-Hodgkin's Lymphoma with Radiolabled Murine, Chimeric, or Humanized LL2, and Anti-CD22 Monoclonal Antibody”Cancer Research Suppl. 55, 5899-5907, Dec. 1, 1995.
Dillman, Robert “Antibodies as Cytotoxic Therapy”Journal of Clinical Oncology, vol. 12, No. 7 (Jul.), 1994: pp 1497-1515.
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Green et al. Antigen-specific human monoclonal antibodies from mice engineered with human Ig heavy and light chain YACS. Nature Genetics 7:13-21, 1994.
Kreitman, R. et al.Cancer Research53, 819-825, Feb. 15, 1993.
Li, J. et al.Cellular Immun, 118, 85-89 (1989).
Kaminski, M. et al.New England J. of Med. 329(7), 459-465.
Uhr, J. et al. U.S. Patent# 5,686,072 (Nov. 11, 1997).
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Baldwin, R. & Byers, V. Biological Approaches to Cancer Treat. 1993.
Foley & Lardner
Harris Alana M.
Immunomedics Inc.
Johnson Nancy A.
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