Claims for Patent: 10,350,178

Summary for Patent: 10,350,178

Title:	Methods and compositions for treatment of demyelinating diseases
Abstract:	Disclosed herein is a method of prevention of progression of a multiple sclerosis in a patient, comprising the administration of methylglyoxal bis(guanylhydrazone) (MGBG) to the patient in need thereof. Also disclosed herein is a method of prevention or reduction in severity of the initiation phase of autoimmune response in a patient having multiple sclerosis, comprising the administration of MGBG to the patient in need thereof.
Inventor(s):	Blitzer; Jeremy (San Francisco, CA), McKearn; John (St. Louis, MO)
Assignee:	Pathologica LLC (San Francisco, CA)
Application Number:	16/109,824
Patent Claims:	1. A method of prevention of progression of a multiple sclerosis in a patient, comprising the administration of methylglyoxal bis(guanylhydrazone) (MGBG) to the patient in need thereof. 2. The method as recited in claim 1, wherein the symptoms in a relapse of multiple sclerosis are decreased. 3. The method as recited in claim 1, wherein the symptoms of multiple sclerosis are prevented to a clinically significant or detectable level. 4. The method as recited in claim 1, wherein the progression to an increased occurrence or severity of flare-ups of multiple sclerosis is prevented, the flare-up being characterized by increased demyelination or a reduced capacity for movement over time. 5. The method as recited in claim 1, wherein the administration of MGBG is oral. 6. The method as recited in claim 2, wherein MGBG is dosed at 20 mg/day to 400 mg/day. 7. The method as recited in claim 6, 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 (including latent bacterial and viral), impairment of innate immunity, impairment of adaptive immunity, and flushing, as compared to interferon beta-1a, interferon beta-1b, glatiramer acetate, peginterferon beta-1a, daclizumab, teriflunomide, fingolimod, dimethyl fumarate, alemtuzumab, mitoxantrone, or natalizumab. 8. The method as recited in claim 7, 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. 9. The method as recited in claim 8, wherein the agent is fingolimod. 10. The method as recited in claim 9, wherein fingolimod is dosed at 0.5 mg per day. 11. The method as recited in claim 9, wherein fingolimod is dosed at less than 0.5 mg per day. 12. The method as recited in claim 9, wherein fingolimod is dosed at 0.25 mg per day. 13. The method as recited in claim 7, wherein administration occurs concomitant with a reduced incidence of at least one side effect 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 7, wherein administration occurs concomitant with a reduced incidence of at least two side effects chosen from cytopenia, nephrotoxicity, hepatotoxicity, cardiotoxicity, and teratogenicity. 16. The method as recited in claim 15, wherein the cytopenia is chosen from lymphopenia and neutropenia. 17. The method as recited in claim 15, wherein administration occurs concomitant with a reduced incidence of cytopenia, nephrotoxicity, and hepatotoxicity. 18. The method as recited in claim 17, wherein the cytopenia is chosen from lymphopenia and neutropenia. 19. The method as recited in claim 17, wherein administration additionally occurs concomitant with a reduced incidence of cardiotoxicity, and teratogenicity.

Details for Patent 10,350,178

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
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