Claims for Patent: 9,452,175

Summary for Patent: 9,452,175

Title:	Pregnancy hormone combination for treatment of autoimmune diseases
Abstract:	The present invention relates to pregnancy hormone combinations and methods of treatment for autoimmune diseases having at least two hormonal components, a pregnancy hormone (such as estriol), and a gestagen (such as levonorgestrel or norethindrone) thereby providing for the continuous, uninterrupted administration of pregnancy hormones for the treatment for autoimmune disorders, such as multiple sclerosis.
Inventor(s):	Voskuhl; Rhonda (Los Angeles, CA)
Assignee:	The Regents of the University of California (Oakland, CA)
Application Number:	14/524,708
Patent Claims:	1. A method for treating an autoimmune disease in a subject, comprising administering to the subject an estrogen for a continuous administration period of about 2 to 4 months, and administering to the subject a gestagen for about 2 to 4 weeks during the administration period. 2. A method for prevention of relapse of an autoimmune disease in a subject, comprising administering to the subject an estrogen for a continuous administration period of about 2 to 4 months, and administering to the subject a gestagen for about 2 to 4 weeks during the administration period. 3. A method to delay the onset of or treat the symptoms of multiple sclerosis in a subject, comprising administering to the subject an estrogen for a continuous administration period of about 2 to 4 months, and administering to the subject a gestagen for about 2 to 4 weeks during the administration period. 4. The method of claim 1, wherein the estrogen is estriol, estrone, 17.alpha.-estradiol, or 17.beta.-estradiol, or a metabolite or derivative of estriol, estrone, or 17.beta.-estradiol. 5. The method of claim 4, wherein the estrogen is estriol, and the estriol is administered at a dosage of about 1 mg to 20 mg per day. 6. The method of claim 1, wherein the gestagen is progesterone, chlormadinone acetate, norethisterone acetate, norethindrone, cyproterone acetate, desogestrel, or levonorgestrel. 7. The method of claim 6, wherein the gestagen is norethindrone, and the norethindrone is administered at a dosage of about 0.2 mg to 3 mg per day. 8. The method of claim 1 or 2, wherein the autoimmune disease is multiple sclerosis, psoriasis, myasthenia gravis, rheumatoid arthritis, uveitis, Sjogren's syndrome, Hashimoto's thyroiditis, or lupus. 9. The method of claim 1, wherein the gestagen is administered for about 2 weeks during the administration period. 10. A method of claim 1, further comprising administering a third agent selected from glatiramer acetate, interferon-.beta. 1a, interferon-.beta. 1b, mitoxantrone, natalizumab, mycophenolate mofetil, paclitaxel, cyclosporin A, prednisone, methyl prednisone, azathioprine, cyclophosphamide, methotrexate, cladribine, 4-aminopyridine, tizanidine, and sphingosine-1-phosphate receptor modulator. 11. The method of claim 5, wherein the estriol is administered at a dosage of about 5 mg to 10 mg per day. 12. The method of claim 11, wherein the estriol is administered at a dosage of about 8 mg per day. 13. The method of claim 4, wherein the estrogen is estriol, and the estriol is estriol succinate, estriol sulfamate, or estriol dihexanoate. 14. The method of claim 4, wherein the estrogen is estriol, and the treatment results in a serum estriol concentration of at least about 2 ng/mL. 15. The method of claim 14, wherein the treatment results in a serum estriol concentration of about 10 ng/mL to about 35 ng/mL. 16. The method of claim 10, wherein the third agent is glatiramer acetate copolymer-1, and the glatiramer acetate copolymer-1 is administered at about 20 mg per day. 17. The method of claim 10, wherein the third agent is interferon .beta.-1a, and the interferon .beta.-1a is administered at about 30 .mu.g once per week. 18. The method of claim 10, wherein the third agent is interferon .beta.-1b, and the interferon .beta.-1b is administered at about 0.25 mg every other day. 19. The method of claim 10, wherein the third agent is prednisone, and the prednisone is administered at about 5 mg to about 60 mg per day. 20. The method of claim 10, wherein the third agent is methyl prednisone, and the methyl prednisone is administered at about 1 mg to about 2 mg per day. 21. The method of claim 8, wherein the autoimmune disease is relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis.

Details for Patent 9,452,175

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		2027-06-04
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	05/17/1996		2027-06-04
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	05/28/2003		2027-06-04
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	02/27/2012		2027-06-04
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	03/07/2002		2027-06-04