Immune reactivity to HER-2/neu protein for diagnosis and treatment of malignancies in which the HER-2/neu oncogene is associated
AssigneeUniversity of Washington
InventorsMartin A. Cheever, Mary L. Disis
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Abstract
Methods for the detection, monitoring and treatment of malignancies in which the HER-2/neu oncogene is associated are disclosed. Detection of specific T cell activation (e.g., by measuring the proliferation of T cells) in response to in vitro exposure to the HER-2/neu protein, or detection of immunocomplexes formed between the HER-2/neu protein and antibodies in body fluid, allows the diagnosis of the presence of a malignancy in which the HER-2/neu oncogene is associated. The present invention also discloses methods and compositions, including peptides, for treating such malignancies.
Claims20
A method of screening for the presence of a malignancy in a warm-blooded animal, wherein a HER-2/neu oncogene is associated with the malignancy, comprising the steps of:
- (a) contacting a body fluid, suspected of containing antibodies specific for HER-2/neu protein, with HER-2/neu protein;
- (b) incubating the body fluid under conditions and for a time sufficient to allow immunocomplexes to form;
- and
- (c) detecting the presence or absence of immunocomplexes formed between the HER-2/neu protein and antibodies in the body fluid specific for the HER-2/neu protein, thereby determining the presence or absence of the malignancy.
A method for detecting changes in the level of antibodies specific for HER-2/neu protein in a human, comprising the steps of:
- (a) contacting a first body fluid sample with HER-2/neu protein;
- (b) incubating the sample under conditions and for a time sufficient to allow immunocomplexes to form;
- (c) detecting immunocomplexes formed between the HER-2/neu protein and antibodies in the sample that are specific for the HER-2/neu protein;
- (d) repeating steps (a), (b) and (c) on a second body fluid sample taken from the same individual at a time subsequent to the first sample;
- and
- (e) comparing the number of immunocomplexes detected in the first and second body fluid samples, thereby determining whether a change in the level of antibody specific for HER-2/neu protein has occurred.
Dependencies are inferred from the claim text.