IP Library Granted Patent US 10,155,005
Granted Patent B2
US 10,155,005 · App. 15/460,895 · Granted Dec 18, 2018

Methods of reducing mammographic breast density and/or breast cancer risk

Inventor: Stephen Nigel Birrell (Piccadilly, AU)
Assignee: HAVAH THERAPEUTICS PTY LTD.
A61K31/568A61K9/0024A61K9/0053A61K31/4196A61K31/569A61K45/06
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Quick Facts
Patent No.
US 10,155,005
App. No.
15/460,895
Granted
Dec 18, 2018
Kind
B2
Abstract

The present disclosure is directed to generally methods for treating mammographic breast density and/or breast stiffness in a patient in need thereof, such as a premenopausal or perimenopausal patient, comprising the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor. These methods may also be useful in post-menopausal woman.

Claims (26)

1. A method of treating mammographic breast density and/or breast stiffness in a patient in need thereof, comprising administering to the patient:

i) an effective amount of an androgenic agent selected from the group consisting of: testosterone, methyltestosterone, enanthate testosterone, propionate testosterone, cypionate testosterone, and undecanoate testosterone; and

ii) 0.1-10 mg of anastrozole;

wherein the method mitigates or reduces the treated patient's risk of developing breast cancer.

2. The method of claim 1 , wherein the patient is peri-menopausal.

3. The method of claim 1 , wherein the patient is premenopausal.

4. The method of claim 1 , wherein the patient's breast has a mammographic breast density of 25% or greater via 2-D determination.

5. The method of claim 1 , wherein the patient's breast has a BIRADS score of 3 or 4 (or c or d).

6. The method of claim 1 , wherein the patient's breast has a mammographic breast density of 7.5% or greater via 3-D determination.

7. The method of claim 1 , wherein the method reduces or decreases the mammographic breast density of the patient's breast between one or more annual intervening mammographic detections.

8. The method of claim 1 , wherein the method reduces or decreases the breast stiffness of the patient's breast between one or more annual intervening mammographic detections.

9. The method of claim 1 , wherein the method reduces or decreases the patient's pain during breast compression.

10. The method of claim 1 , wherein the method reduces or minimizes the patient's BIRADS score by 1 or more points between one or more annual intervening mammographic detections.

11. The method of claim 1 , wherein the method enhances, increases, or improves, one or more of the following:

i) mammographic visualization or detection of the patient's breast;

ii) breast compression during mammographic visualization or detection of the patient's breast;

iii) the treated patient's compliance of having regular mammographic visualizations or detections; or

iv) combinations thereof.

12. The method of claim 1 , wherein the anastrozole is administered to the patient orally, transdermally or via a subcutaneous implant.

13. The method of claim 1 , wherein the anastrozole is administered in an amount of 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, or 6 mg.

14. The method of claim 1 , wherein the androgenic agent is administered to the patient via a subcutaneous implant, injection, transdermally, or by intramuscular administration.

15. The method of claim 14 , wherein the androgenic agent is testosterone.

16. The method of claim 15 , wherein the effective amount of the testosterone is in the range of between 30-150 mg.

17. The method of claim 1 , wherein the androgenic agent is enanthate testosterone, propionate testosterone, cypionate testosterone, or undecanoate testosterone.

18. The method of claim 1 , wherein the androgenic agent is methyltestosterone.

19. The method of claim 1 , wherein the patient is post-menopausal.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2017
From: BIRRELL, STEPHEN NIGEL
To: CHAVAH PTY LTD.
Reel/Frame 041599/0162 →
CHANGE OF NAME Recorded Mar 16, 2017
From: CHAVAH PTY LTD.
To: HAVAH THERAPEUTICS PTY LTD.
Reel/Frame 041599/0268 →
Continuity (4)
Continuation 15138833 · Apr 26, 2016
Continuation 14920192 · Oct 22, 2015
Provisional Application 62067297 · Oct 22, 2014
Related Publication 20170246185A1 · Aug 31, 2017