Methods and kits for monitoring resistance to therapeutic agents
First Claim
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1. A method of monitoring the therapeutic inactivating capacity of a subject, said method comprising:
- a) obtaining a sample from a subject to be monitored;
b) assessing said sample for a therapeutic inactivating component specific for a therapeutic agent that has been administered, is being administered or will be administered to said subject, wherein said therapeutic inactivating component binds with said therapeutic agent and interferes with the utility of said therapeutic agent, with aproviso that when said therapeutic inactivating component is an antibody, said antibody is not assessed via plasmon resonance; and
c) deciding to initiate, terminate, or adjust the level of administration of said therapeutic agent to said subject based on said assessed therapeutic inactivating component.
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Abstract
The present invention relates to novel methods and kits for monitoring the therapeutic inactivating capacity of a subject. Moreover, the present invention further relates to methods and kits for determining and/or monitoring a therapeutic protocol for a subject afflicted with auto antibodies specific for a natural substance, wherein these auto antibodies develop as a result of therapeutic administration of the natural substance or an analog thereof. These methods and kits can be used, for example, to initiate, terminate, or adjust the level of administration of any of a variety of therapeutic agents.
16 Citations
64 Claims
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1. A method of monitoring the therapeutic inactivating capacity of a subject, said method comprising:
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a) obtaining a sample from a subject to be monitored;
b) assessing said sample for a therapeutic inactivating component specific for a therapeutic agent that has been administered, is being administered or will be administered to said subject, wherein said therapeutic inactivating component binds with said therapeutic agent and interferes with the utility of said therapeutic agent, with aproviso that when said therapeutic inactivating component is an antibody, said antibody is not assessed via plasmon resonance; and
c) deciding to initiate, terminate, or adjust the level of administration of said therapeutic agent to said subject based on said assessed therapeutic inactivating component. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A method for determining or monitoring a therapeutic protocol for a subject afflicted with an auto antibody specific for a natural substance, wherein said auto antibody developed as a result of therapeutic administration of the natural substance or an analog thereof, said method comprising:
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a) obtaining a sample from said subject;
b) assessing said sample for the presence and/or level of said natural substance;
c) assessing said sample for the presence of said auto antibody that specifically binds said natural substance, wherein said auto antibody is not assessed via plasmon resonance or a competitive assay, and said natural substance is not insulin or thyroglobulin; and
d) deciding to initiate, terminate, or adjust the level of administration of the natural substance to said subject based on said assessed auto antibody. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. A method for determining or monitoring a therapeutic protocol for a subject receiving or about to receive administration of a chemical moiety-based therapeutic agent, said method comprising:
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a) obtaining a sample from said subject;
b) assessing said sample for a therapeutic inactivating component specific for said chemical moiety-based therapeutic agent that has been administered, is being administered or will be administered to said subject, wherein said therapeutic inactivating component binds with said chemical moiety-based therapeutic agent and interferes with the utility of said therapeutic agent; and
c) deciding to initiate, terminate, or adjust the level of administration of said chemical moiety-based therapeutic agent to said subject based on said assessed therapeutic inactivating component. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50)
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51. A kit for monitoring therapeutic inactivating capacity of a subject, which kit comprises:
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a) a means for assessing therapeutic inactivating component of a sample obtained from a subject to a therapeutic agent that has been administered, is being administered or will be administered to said subject; and
b) instructions for making a decision for initiating, terminating or adjusting the level of administration of said therapeutic agent to said subject based on said assessed therapeutic inactivating component. - View Dependent Claims (52, 53, 54, 55)
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56. A kit comprising:
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a) a therapeutic agent; and
b) instructions for monitoring the therapeutic inactivating capacity of a subject to said therapeutic agent. - View Dependent Claims (57)
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58. A method of monitoring the hormone inactivating capacity of a subject, said method comprising:
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a) obtaining a sample from a subject to be monitored;
b) assessing said sample for a hormone inactivating component specific for a hormone, wherein said hormone inactivating component binds with said hormone and interferes with the normal biological activity of said hormone;
with aproviso that when said hormone inactivating component is an antibody, said antibody is not assessed via plasmon resonance, and a further proviso that when said hormone is insulin or thyroglobulin, said hormone inactivating component is not an auto antibody; and
c) deciding to initiate, terminate, or adjust the level of therapeutic administration of said hormone to said subject based on said assessed hormone inactivating component. - View Dependent Claims (59, 60, 61, 62, 63, 64)
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Specification