System and method for diagnosis and treatment
This invention relates to a low cost rapid response diagnostic system to determine cortisol levels in patients selected as potential candidates for GCR (glucocorticoid receptor) antagonist therapy utilizing a GCR antagonist, such as ORG 34517. The rapid, sensitive, and inexpensive test can be used to determine patients who have non-normal cortisol production or disordered circadian rhythms as a method for selecting subjects for GCR antagonist therapy for whom it is likely to have beneficial and/or therapeutic effects, and can also be used to monitor changes in cortisol levels in response to treatment.
1. A pharmaceutical composition for treating neoplasia in a patient which is characterized by expression of a glucocorticoid receptor, comprising:
a) therapeutically effective amounts of at least one neoplasia-treating agent selected from the group consisting of taxanes, and combinations thereof;
b) the GCR (glucocorticoid receptor) antagonist ORG 34517; and
c) optionally, at least one pharmaceutically acceptable carrier;
wherein the neoplasia is selected from the group consisting of hepatocellular carcinoma, breast cancer, prostate cancer, lung cancer, and ovarian cancer.
2. The pharmaceutical composition of claim 1 , wherein the neoplasia is chemo-resistant ER−/GR+breast cancer.
3. The pharmaceutical composition of claim 1 , wherein the neoplasia expresses multidrug resistance genes when GR is activated through binding by endogenous cortisol.
4. A kit for the treatment or amelioration of a condition in a patient in need of such treatment comprising:
(a) the pharmaceutical composition of claim 3 ; and
(b) at least one blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of (a) and instructions for use of the pharmaceutical composition.
5. A product of manufacture comprising a blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of claim 3 and instructions for use of the pharmaceutical composition.
6. A kit for the treatment or amelioration of a condition in a patient in need of such treatment comprising:
(a) the pharmaceutical composition of claim 1 ; and
(b) at least one blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of (a) and instructions for use of the pharmaceutical composition.
7. A product of manufacture comprising a blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of claim 1 and instructions for use of the pharmaceutical composition.
8. A pharmaceutical composition for treating neoplasia in a patient which is characterized by expression of a glucocorticoid receptor, comprising:
a) therapeutically effective amounts of at least one neoplasia-treating agent selected from the group consisting of abiraterone, pharmaceutically acceptable salts thereof, derivatives thereof, and combinations thereof;
b) the GCR (glucocorticoid receptor) antagonist ORG 34517; and
c) optionally, at least one pharmaceutically acceptable carrier;
wherein the neoplasia is selected from the group consisting of hepatocellular carcinoma, breast cancer, prostate cancer, lung cancer, and ovarian cancer.
9. A kit for the treatment or amelioration of a condition in a patient in need of such treatment comprising:
(a) the pharmaceutical composition of claim 8 ; and
(b) at least one blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of (a) and instructions for use of the pharmaceutical composition.
10. A product of manufacture comprising a blister package; a lidded blister; a blister card or packet; a clamshell; an intravenous (IV) package, IV packette or IV container; a tray or a shrink wrap comprising the pharmaceutical composition of claim 8 and instructions for use of the pharmaceutical composition.