Methods and systems for identifying and treating anti-progestin sensitive tumors
AssigneeInvivis Pharmaceuticals Inc.
InventorErard Gilles
Life of this patent
Estimating the term…
Abstract
Methods and systems for identifying and treating a patient suspected of having a tumor susceptible to growth inhibition by anti-progestins are provided. The degree of focal distribution of the progesterone receptor can be used to identify tumors susceptible to treatment with anti-progestin therapy.
Claims20
A method of inhibiting the growth of a tumor susceptible to growth inhibition by anti-progestins, comprising:
- a) obtaining a tissue sample suspected of being tumorigenic or cancerous from a patient;
- b) identifying progesterone receptor positive cells in the tissue sample;
- c) determining the degree of focal distribution of the progesterone receptor in nuclei of the progesterone positive cells from the tissue sample;
- and
- d) administering an anti-progestin to the patient if the degree of focal distribution in the tissue sample is greater than about 5% of the progesterone receptor positive cells.
A method of treating patient with a tumor susceptible to growth inhibition by anti-progestins, comprising:
- a) obtaining a tissue sample suspected of being tumorigenic from a patient;
- b) exposing the tissue to an anti-progesterone receptor antibody;
- c) identifying progesterone receptor positive cells in the tissue sample;
- b) determining the focal binding distribution of the progesterone receptor in nuclei of cells from the tissue wherein if the focal binding distribution is greater than 5% of the progesterone receptor positive cells in the tissue sample with an A or AD binding pattern, an anti-progestin is administered to the patient in a dosage range of about 10 to about 200 mg per day.
A method of treating a patient suspected of having a tumor susceptible to growth inhibition by onapristone, comprising:
- a) identifying a patient exhibiting greater than about 5% focal distribution of the progesterone receptor in the cell nuclei of progesterone receptor positive cells in a tumor tissue biopsy;
- and
- b) administering onapristone to the patient in an amount from about 10 to about 200 mg per day.
A method of screening a drug candidate for the ability to decrease focal distribution of the progesterone receptor in the nuclei of progesterone receptor positive cells in a tumor comprising:
- obtaining at least two tumor tissue specimens from the same tumor, exposing one tumor tissue specimen to a drug candidate, exposing the tumor tissue specimens to anti-progesterone receptor antibodies, determining the degree of focal distribution of progesterone receptors in the nuclei of the progesterone receptor positive cells from the tumor tissue specimens, and determining if the focal distribution of the progesterone receptor in the tumor tissue specimen exposed to the drug candidate is decreased compared to tumor tissue specimens not exposed to the drug candidate, wherein if the drug candidate decreases the focal distribution of the progesterone receptor in the progesterone receptor positive cells of the tissue specimen exposed to the drug candidate, the drug candidate is capable of decreasing focal distribution of the progesterone receptor in progesterone receptor positive cells of the tumor.
A system for classifying a tumor susceptible for treatment with an anti-progestin, comprising a tissue sample and at least one antibody or antibody binding fragment capable of detecting the progesterone receptor wherein the antibody or antibody binding fragment is used to determine the degree of focal distribution of the progesterone receptor in the progesterone receptor positive nuclei of cells from a tumor tissue specimen and wherein the tumor is susceptible to treatment with an anti-progestin if the degree of focal distribution in the cell nuclei of the progesterone positive cells is greater than about 5%.
Dependencies are inferred from the claim text.