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Publication Number

US-8822438-B2

Patent

Publication Date

2014-09-02

Expiration Date


Abstract

Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17α-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.

Core Innovation

The document discloses cancer treatment methods and pharmaceutical compositions using a 17α-hydroxylase/C17,20-lyase inhibitor, preferably abiraterone acetate, for administration to a human. The inhibition is provided as abiraterone acetate or a pharmaceutically acceptable salt, including abiraterone acetate mesylate, as well as formula-based inhibitor embodiments, derivatives, and pharmaceutically acceptable salts.

The disclosed treatment comprises administering abiraterone acetate, or a pharmaceutically acceptable salt thereof, together with a therapeutically effective amount of at least one additional therapeutic agent. The additional therapeutic agent includes anti-cancer drugs and steroids or corticosteroids, including glucocorticoids such as prednisone, hydrocortisone, and dexamethasone.

The document further provides combination examples for cancer treatment, including abiraterone acetate and glucocorticoids, and combinations with anti-cancer agents such as mitoxantrone, paclitaxel, docetaxel, and hormonal ablation agents or anti-androgen agents such as leuprolide, goserelin, triptorelin, seocalcitol, bicalutamide, and flutamide.

Claims Coverage

The document provides one independent claim, which covers treating prostate cancer in a human by co-administering abiraterone acetate, or a pharmaceutically acceptable salt, and prednisone, with dependent claims that narrow the patient and treatment context and refine dosage parameters and selection of prior or additional therapeutic agents.

Co-administration of abiraterone acetate and prednisone for prostate cancer treatment

A method for the treatment of a prostate cancer in a human comprising administering a therapeutically effective amount of abiraterone acetate, or a pharmaceutically acceptable salt thereof, together with a therapeutically effective amount of prednisone.

Quantitative abiraterone acetate and prednisone dosing ranges

The method further comprises administering abiraterone acetate, or a pharmaceutically acceptable salt, at about 500 mg/day to about 1500 mg/day together with prednisone at about 0.01 mg/day to about 500 mg/day.

Prednisone dosage-form amount

A method in which a therapeutically effective amount of prednisone is administered in a dosage form containing about 5 mg of prednisone.

Treatment of refractory prostate cancer

The method is applied to refractory prostate cancer.

Refractory prostate cancer not responding to at least one anti-cancer agent

The method is performed for refractory prostate cancer that is not responding to at least one anti-cancer agent.

Non-response agent selected from hormonal ablation, anti-androgen, or anti-neoplastic categories

The anti-cancer agent associated with the non-response includes a hormonal ablation agent, an anti-androgen agent, or an anti-neoplastic agent.

Claim coverage centers on administering abiraterone acetate, or a pharmaceutically acceptable salt, with prednisone for treating prostate cancer, with dependent claims further specifying dosing ranges and dosage-form amounts and narrowing to refractory prostate cancer that is not responding to at least one anti-cancer agent, where the anti-cancer agent is categorized as hormonal ablation, anti-androgen, or anti-neoplastic.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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