Claims for Patent: 10,085,955

Summary for Patent: 10,085,955

Title:	Methods and compositions for treatment of demyelinating diseases
Abstract:	Disclosed herein are new oral pharmaceutical compositions of SAMDC inhibitors, polyamine analogs, and polyamine biosynthesis inhibitors, and their application for the treatment of conditions including demyelinating diseases, autoimmune disorders affecting the nervous system, and other neurodegenerative conditions.
Inventor(s):	Blitzer; Jeremy (San Francisco, CA), McKearn; John (Saint Louis, MO)
Assignee:	Pathologica LLC (San Francisco, CA)
Application Number:	14/759,599
Patent Claims:	1. A method of treatment of progressive multiple sclerosis in a patient, comprising the administration to the patient, in need thereof, of a therapeutically effective amount of MGBG. 2. The method as recited in claim 1, wherein the administration of MGBG is oral. 3. The method as recited in claim 2, wherein MGBG is dosed at 20 mg/day to 400 mg/day. 4. The method as recited in claim 3, additionally comprising the administration of an agent chosen from interferon beta-1a, interferon beta-1b, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, laquinimod, dimethyl fumarate, and teriflunomide. 5. The method as recited in claim 4, wherein the agent is fingolimod. 6. The method as recited in claim 5, wherein fingolimod is dosed at 0.5 mg per day. 7. The method as recited in claim 5, wherein fingolimod is dosed at less than 0.5 mg per day. 8. The method as recited in claim 5, wherein fingolimod is dosed at 0.25 mg per day. 9. The method as recited in claim 1, wherein the treatment prevents relapse or progression of MS. 10. The method as recited in claim 1, wherein administration occurs concomitant with a reduced incidence of at least one side effect chosen from cytopenia, nephrotoxicity, hepatotoxicity, cardiotoxicity, teratogenicity, decreased pulmonary function, macular edema, peripheral neuropathy, severe skin reactions, increased risk of infections, impairment of innate immunity, impairment of adaptive immunity, and flushing, as compared to Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Extavia (interferon beta-1b), Glatopa (glatiramer acetate), Plegridy (peginterferon beta-1a), Rebif (interferon beta-1a), Zinbryta (daclizumab), Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Lemtrada (alemtuzumab), Novantrone (mitoxantrone), or Tysabri (natalizumab). 11. The method as recited in claim 10, wherein administration occurs concomitant with a reduced incidence of at least one side effect chosen from cytopenia, nephrotoxicity, hepatotoxicity, cardiotoxicity, and teratogenicity. 12. The method as recited in claim 11, wherein the cytopenia is chosen from lymphopenia and neutropenia. 13. The method as recited in claim 10, wherein administration occurs concomitant with a reduced incidence of at least two side effects chosen from cytopenia, nephrotoxicity, hepatotoxicity, cardiotoxicity, and teratogenicity. 14. The method as recited in claim 13, wherein the cytopenia is chosen from lymphopenia and neutropenia. 15. The method as recited in claim 13, wherein administration occurs concomitant with a reduced incidence of cytopenia, nephrotoxicity, and hepatotoxicity. 16. The method as recited in claim 15, wherein the cytopenia is chosen from lymphopenia and neutropenia. 17. The method as recited in claim 16, wherein administration additionally occurs concomitant with a reduced incidence of cardiotoxicity, and teratogenicity. 18. The method as recited in claim 1, wherein the progressive multiple sclerosis is primary progressive multiple sclerosis. 19. The method as recited in claim 1, wherein the progressive multiple sclerosis is secondary progressive multiple sclerosis.

Details for Patent 10,085,955

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		2033-01-08
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	05/17/1996		2033-01-08
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	05/28/2003		2033-01-08
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	02/27/2012		2033-01-08
Emd Serono, Inc.	REBIF	interferon beta-1a	Injection	103780	03/07/2002		2033-01-08