Combination therapy for the treatment of estrogen-sensitive disease
OwnerMark Stanford Moran, Peter J. Langeckerinventors
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Abstract
The present invention provides methods which increase the effectiveness of combination drug therapies for treating estrogen-sensitive diseases, such as breast cancer, as well as novel combinations useful to treat such diseases.
Claims79
A process for identifying a combination of drugs for treatment of breast cancer in an animal, which process comprises
- identifying antiestrogen drugs and a therapeutically-effective dosage range for an antiestrogen so identified,
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for the antiestrogen,
- identifying sex steroid enzyme inhibitor drugs and therapeutically-effective dosage ranges for an enzyme inhibitor so identified,
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics of an enzyme inhibitor so identified,
- choosing each drug and a dosage range for each drug such that each drug exhibits useful therapeutic activity but each drug exhibits minimal interference with the absorption, distribution, metabolism, and excretion of the other drug.
A method of treating breast cancer in an animal, which method comprises
- administering to the animal a therapeutically-effective amount of an antiestrogen drug and
- concurrently administering a therapeutically-effective amount of a sex steroid enzyme inhibitor drug, wherein the antiestrogen and the enzyme inhibitor, and dosage ranges for each, are chosen so that there is minimal material interference by one drug on the absorption, distribution, metabolism, and excretion (ADME) of the other drug.
A process for identifying a combination of drugs for prevention of breast cancer in an animal predisposed to such cancer, which process comprises
- identifying antiestrogen drugs and a therapeutically-effective dosage range for an antiestrogen so identified,
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for the antiestrogen,
- identifying sex steroid enzyme inhibitor drugs and therapeutically-effective dosage ranges for an enzyme inhibitor so identified,
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics of an enzyme inhibitor so identified,
- choosing each drug and a dosage range for each drug such that each drug exhibits useful therapeutic activity but each drug exhibits minimal interference with the absorption, distribution, metabolism, and excretion of the other drug.
A method of preventing breast cancer in an animal predisposed to such cancer, which process comprises
- administering to the animal a therapeutically-effective amount of an antiestrogen drug and
- concurrently administering a therapeutically-effective amount of a sex steroid enzyme inhibitor drug, wherein the antiestrogen and the enzyme inhibitor, and dosages for each, are chosen so that there is minimal material interference by one drug on the absorption, distribution, metabolism, and excretion of the other drug.
A process for optimizing treatment of a breast cancer patient, which process comprises
- identifying antiestrogens and a therapeutically-effective dosage range for an antiestrogen so identified,
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for the antiestrogen in the patient;
- identifying sex steroid enzyme inhibitors and a therapeutically-effective dosage range for an enzyme inhibitor so identified;
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for the enzyme inhibitors so identified;
- selecting the antiestrogen and an enzyme inhibitor, and a dosage range for each, so that material interference is minimized with respect to the absorption, distribution, metabolism, and excretion characteristics of one towards the other;
- and
- co-administering the selected antiestrogen and the enzyme inhibitor to the patient at the dosages selected.
A process for optimizing a cancer-preventive regimen in an animal predisposed to such cancer, which process comprises
- identifying antiestrogens and a therapeutically-effective dosage range for an antiestrogen so identified;
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for the antiestrogen in the animal;
- identifying sex steroid enzyme inhibitors and a therapeutically-effective dosage range for an enzyme inhibitor so identified;
- determining the relevant aspects of absorption, distribution, metabolism, and excretion characteristics for an enzyme inhibitor so identified;
- selecting the antiestrogen and an enzyme inhibitor, and a dosage range for each, so that material interference is minimized with respect to the absorption, distribution, metabolism, and excretion characteristics of one towards the other;
- and
- co-administering the chosen antiestrogen and the enzyme inhibitor to the animal at the dosages selected.
A kit useful for treating breast cancer in a patient in need of treatment, which kit comprises
- an antiestrogen drug in a dosage form to provide a therapeutically-effective amount of the antiestrogen and
- a therapeutically-effective amount of a sex steroid enzyme inhibitor drug, wherein the dosage form and amount of each drug are chosen so that there is minimal material interference with respect to absorption, distribution, metabolism, and excretion characteristics of one drug towards the other drug.
A kit useful for preventing breast cancer in a patient predisposed to such cancer, which kit comprises
- an antiestrogen drug in a dosage form to provide a therapeutically effective amount of the antiestrogen and
- a therapeutically effective amount of an sex steroid enzyme inhibitor drug, wherein the dosage form and amount of each drug are chosen so that material interference is minimized with respect to absorption, distribution, metabolism, and excretion characteristics of one drug towards the other drug.
A pharmaceutical composition for treating or preventing breast cancer that comprises a therapeutically-effective amount of an antiestrogen drug and a therapeutically-effective amount of a sex steroid enzyme inhibitor drug, wherein the amount of each drug is chosen so that there is minimal material interference between one drug's absorption, distribution, metabolism, and excretion characteristics and the other agent's ADME characteristics in a patient.
Dependencies are inferred from the claim text.