Diagnostic and therapeutic methods using the H37 tumor suppressor gene
AssigneeThe Regents of the University of California
InventorsDennis J. Slamon, Juliana J. Oh
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Abstract
The present invention relates to the identification of the H37 tumor suppressor gene and methods of diagnosing and treating a disease or disorder characterized by abnormal cellular proliferation, such as a tumor or cancer. Diagnosis is accomplished examining or monitoring cells for perturbations in H37 expression or function. Treatment is accomplished by inserting a host cell compatible H37 expression vector or an effective amount of H37 protein into a cell or cells in need of treatment.
Claims27
A method for monitoring human H37 gene products comprising:
- determining the status of H37 gene products expressed by cells in a tissue sample from an individual;
- comparing the status so determined to the status of H37 gene products in a corresponding normal sample;
- and
- identifying an alteration in H37 gene products in the tissue sample relative to the normal sample.
A method for evaluating a neoplasm in a patient comprising examining the quantity of functional H37 gene products in cells from neoplastic tissue of the patient, and comparing the quantity of functional H37 gene products in neoplastic cells to the quantity of functional H37 gene products in non-neoplastic cells of the patient, wherein a reduced quantity of functional H37 gene products in the neoplastic cells is indicative of growth disregulation.
A method of examining a test biological sample comprising a human breast, ovarian or lung cell for evidence of altered cell growth, the method comprising evaluating the levels of H37 polynucleotides in the biological sample, wherein a decrease in the levels of H37 polynucleotides in the test sample relative to a normal tissue sample provide evidence of altered cell growth;
- and wherein the levels of H37 polynucleotides in the cell are evaluated by contacting the sample with a polynucleotide probe that specifically hybridizes to a H37 nucleotide sequence shown in SEQ ID NO:
- 1 and evaluating the presence of a hybridization complex formed by the hybridization of the polynucleotide probe with H37 polynucleotides in the sample.
A method of examining a test biological sample comprising a human breast, ovarian or lung cell for evidence of altered cell growth, the method comprising evaluating the levels of H37 polypeptides in the biological sample, wherein a decrease in the levels of H37 polypeptides in the test sample relative to a normal tissue sample provide evidence of altered cell growth;
- and wherein the levels of H37 polypeptides in the cell are evaluated by contacting the sample with an antibody that immunospecifically binds to a H37 polypeptide sequence shown in SEQ ID NO:
- 2 and evaluating the presence of a complex formed by the binding of the antibody with H37 polypeptides in the sample.
A composition comprising an isolated H37 polynucleotide that encodes the amino acid sequence shown in SEQ ID NO:
- 2.
A composition comprising an antisense H37 polynucleotide which hybridizes to H37 mRNA in a mammalian cell such that the growth of the cell is modulated, wherein the polynucleotide hybridizes to a complement of the H37 polynucleotide shown in SEQ ID NO:
- 1 under stringent conditions.
A composition comprising an isolated H37 polypeptide having the amino acid sequence shown in SEQ ID NO:
- 2.
A kit comprising:
- a container, a label on said container, and a composition contained within said container;
- wherein the composition includes a polynucleotide that hybridizes to a complement of the H37 polynucleotide shown in SEQ ID NO:
- 1 under stringent conditions, the label on said container indicates that the composition can be used to evaluate the presence of H37 in at least one type of mammalian cell, and instructions for using the H37 polynucleotide for evaluating the presence of H37 RNA or DNA in at least one type of mammalian cell.
A method of inhibiting proliferation of a human cell selected from the group consisting of a breast cancer cell, an ovarian cancer cell and a lung cancer cell comprising introducing into the cell an expression vector which comprises a polynucleotide that encodes a polypeptide having an amino acid sequence as shown in SEQ ID NO:
- 2;
- wherein following the introduction, the polypeptide is expressed in the cell so that proliferation of the cell is inhibited.
Dependencies are inferred from the claim text.