Stabilized radiolabeled anti-CD45 immunoglobulin compositions
AssigneeActinium Pharmaceuticals, Inc.
InventorsKaushik Dave, Shubh Sharma
Life of this patent
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Abstract
Compositions and methods are described for stabilizing a radio-iodinated monoclonal IgG antibody for up to 17 days against radiolytic decomposition. The stabilized radiolabeled murine antibody binding the CD45 antigen expressed on various forms of lymphomas is useful as a radiotherapeutic and diagnostic agent in the treatment of human malignancies of hematopoietic origin, including lymphomas.
Claims14
A method for treating a subject afflicted with a hematologic malignancy, the method comprising:
- administering by intravenous administration to the subject a therapeutically effective amount of an aqueous pharmaceutical composition comprising:
- a monoclonal antibody against CD45, wherein the antibody is radiolabeled with 131I, and comprises
- a heavy chain having heavy chain complementarity determining regions with amino acids sequences as set forth in SEQ ID NOS:
- 6-8, and an aspartic acid at position 14, and
- a light chain having light chain complementarity determining regions with amino acids sequences as set forth in SEQ ID NOS:
- 3-5;
- and
- a pharmaceutically acceptable carrier comprising 0.5% to 5.0% (w/v) of ascorbic acid and 0.5% to 4.0% (w/v) of PVP,
- wherein the aqueous pharmaceutical composition is administered either alone or in conjunction with another form of treatment;
- and
- wherein the hematologic malignancy is selected from the group consisting of acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma.
A method for ablating bone marrow cells in a subject afflicted with acute myeloid leukemia prior to the subject's receiving a bone marrow transplant, the method comprising:
- administering by intravenous administration to the subject a therapeutically effective amount of an aqueous pharmaceutical composition comprising:
- a monoclonal antibody against CD45, wherein the antibody is radiolabeled with 131I, and comprises
- a heavy chain having heavy chain complementarity determining regions with amino acids sequences as set forth in SEQ ID NOS:
- 6-8, and an aspartic acid at position 14, and
- a light chain having light chain complementarity determining regions with amino acids sequences as set forth in SEQ ID NOS:
- 3-5;
- and
- a pharmaceutically acceptable carrier comprising 0.5% to 5.0% (w/v) of ascorbic acid and 0.5% to 4.0% (w/v) of PVP.
A method for treating a subject afflicted with a hematologic malignancy, the method comprising:
- administering by intravenous administration to the subject a therapeutically effective amount of an aqueous pharmaceutical composition comprising:
- a monoclonal antibody against CD45, wherein the antibody is radiolabeled with 131I, and comprises a light chain having light chain complementarity determining regions with amino acids sequences as set forth in SEQ ID NOS:
- 3-5, and
- a pharmaceutically acceptable carrier comprising 0.5% to 5.0% (w/v) of ascorbic acid and 0.5% to 4.0% (w/v) of PVP,
- wherein the aqueous pharmaceutical composition is administered either alone or in conjunction with another form of treatment;
- and
- wherein the hematologic malignancy is selected from the group consisting of acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma.
Dependencies are inferred from the claim text.