Claims for Patent: 9,168,262

Summary for Patent: 9,168,262

Title:	Estriol therapy for multiple sclerosis and other autoimmune diseases
Abstract:	The present invention discloses administering steroid hormones to mammals to treat autoimmune related diseases, more particularly, Th1-mediated (cell-mediated) autoimmune diseases including: multiple sclerosis (MS), rheumatoid arthritis (RA), autoimmune thyroiditis and uveitis. Most preferably the invention is used to treat a patient with a therapeutically effective amount of estriol of 8 milligrams once daily via oral administration to treat the symptoms or prevent the onset of multiple sclerosis.
Inventor(s):	Voskuhl; Rhonda R. (Los Angeles, CA)
Assignee:	The Regents of the University of California (Oakland, CA)
Application Number:	13/763,814
Patent Claims:	1. A method of treating a human exhibiting at least one clinical sign or symptom of multiple sclerosis, comprising administering estriol orally at about 4 milligrams to about 16 milligrams per day to ameliorate at least one sign or symptom of multiple sclerosis. 2. The method of claim 1, wherein the estriol is estriol succinate or estriol sulfamate. 3. The method of claim 1, comprising administering about 8 milligrams of estriol per day. 4. The method of claim 1, wherein treatment results in patient serum concentrations of estriol of about 2 to about 30 nanograms per milliliter. 5. The method of claim 1, wherein treatment results in patient serum concentrations of estriol of about 20 to about 30 nanograms per milliliter. 6. The method of claim 1, wherein the treatment results in serum levels of estriol substantially similar to those of a woman in the mid second trimester through the end of the third trimester of pregnancy. 7. The method of claim 1, further comprising administering at least one secondary agent at a therapeutically effective dosage in an effective dosage form at a predetermined interval. 8. The method of claim 7, wherein the secondary agent is administered orally. 9. The method of claim 7, wherein the secondary agent is administered by injection. 10. The method of claim 7, wherein the secondary agent is administered subcutaneously. 11. The method of claim 7, wherein the secondary agent is administered intramuscularly. 12. The method of claim 7, wherein the secondary agent is progesterone. 13. The method of claim 12, wherein progesterone is administered at a dose of about 100 to about 200 milligrams per day. 14. The method of claim 7, wherein the secondary agent is a glucocorticoid. 15. The method of claim 14, wherein the glucocorticoid is prednisone or methyl prednisone. 16. The method of claim 15, wherein the glucocorticoid is prednisone and the prednisone is administered at a dose of about 5 to about 60 milligrams per day. 17. The method of claim 15, wherein the glucocorticoid is methyl prednisone and the methyl prednisone is administered at a dose of about 1 to about 2 milligrams per day. 18. The method of claim 7, wherein the secondary agent is a .beta.-interferon. 19. The method of claim 18, wherein the .beta.-interferon is interferon .beta.-1a or interferon .beta.-1b. 20. The method of claim 19, wherein the .beta.-interferon is interferon .beta.-1b and the interferon .beta.-1b is administered at a dose of about 0.25 mg or less every other day. 21. The method of claim 19, wherein the .beta.-interferon is interferon .beta.-1a and the interferon .beta.-1a is administered at a dose of about 40 mcg to about 50 mcg three times per week. 22. The method of claim 19, wherein the .beta.-interferon is interferon .beta.-1a and the interferon .beta.-1a is administered at a dose of about 20 mcg to about 30 mcg once per week. 23. A method of treating a patient exhibiting at least one clinical sign or symptom of multiple sclerosis, comprising administering estriol orally at a dose of about 4 milligrams to about 16 milligrams each day and administering a secondary agent, wherein the administration of estriol and the secondary agent ameliorates the clinical sign or symptom. 24. The method of claim 7, wherein the secondary agent is glatiramer acetate copolymer-1. 25. The method of claim 24, wherein the glatiramer acetate copolymer-1 is administered at a dose of about 40 mg three times per week.

Details for Patent 9,168,262

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471	07/23/1993		2021-04-25
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	05/17/1996		2021-04-25
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	05/28/2003		2021-04-25
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	02/27/2012		2021-04-25
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	03/07/2002		2021-04-25
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	12/17/2004		2021-04-25