Claims for Patent: 10,144,776

Summary for Patent: 10,144,776

Title:	Treatment of central nervous system disorders by intranasal administration of immunoglobulin G
Abstract:	The present invention provides, among other aspects, methods and compositions for treating a central nervous system (CNS) disorder by delivering a therapeutically effective amount of a composition of pooled human immunoglobulin G (IgG) to the brain via intranasal administration of the composition directly to the olfactory epithelium of the nasal cavity. In particular, methods and compositions for treating Alzheimer\'s disease are provided.
Inventor(s):	Frey; William H. (White Bear Lake, MN), Hanson; Leah Ranae Bresin (Vadnais Heights, MN), Pokropinski; Sharon (Schaumburg, IL), Rausa; Francisco M. (Vernon Hills, IL)
Assignee:	Baxalta Incorporated (Bannockburn, IL) Baxalta GmbH (Zug, CH)
Application Number:	15/335,027
Patent Claims:	1. A method for treating a central nervous system (CNS) disorder in a subject in need thereof, the method comprising: delivering a therapeutically effective amount of a composition comprising pooled human immunoglobulin G (IgG) to the brain of the subject, wherein delivering the composition to the brain comprises intranasally administering the composition to the upper third of the nasal cavity of the subject, wherein at least 40% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 2. The method of claim 1, wherein the CNS disorder is selected from the group consisting of a neurodegenerative disorder of the central nervous system, a systemic atrophy primarily affecting the central nervous system, an extrapyramidal and movement disorder, a demyelinating disorder of the central nervous system, an episodic or paroxysmal disorder of the central nervous system, a paralytic syndrome of the central nervous system, a nerve, nerve root, or plexus disorder of the central nervous system, an organic mental disorder, a mental or behavioral disorder caused by psychoactive substance use, a schizophrenia, schizotypal, or delusional disorder, a mood/affective disorder, neurotic, stress-related, or somatoform disorder, a behavioral syndrome, an adult personality or behavior disorder, a psychological development disorder, and a child onset behavioral or emotional disorder. 3. The method of claim 1, wherein the CNS disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis (ALS), Huntington's disease, cerebral palsy, bipolar disorder, schizophrenia, and Pediatric acute-onset neuropyschiatric syndrome (PANS). 4. The method of claim 1, wherein the CNS disorder is selected from the group consisting of Alzheimer's disease, multiple sclerosis, and Parkinson's disease. 5. The method of claim 1, wherein the CNS disorder is Alzheimer's disease. 6. The method of claim 1, wherein intranasal administration of the composition comprises administration of a liquid drop of the composition directly onto the nasal epithelium. 7. The method of claim 1, wherein intranasal administration of the composition comprises directed administration of a liquid aerosol of the composition to the nasal epithelium located in the upper third of the nasal cavity of the subject. 8. The method of claim 7, wherein at least 50% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 9. The method of claim 7, wherein at least 60% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 10. The method of claim 7, wherein at least 70% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 11. The method of claim 1, wherein intranasal administration of the composition comprises directed administration of a powder aerosol of the composition to the nasal epithelium located in the upper third of the nasal cavity of the subject. 12. The method of claim 11, wherein at least 50% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 13. The method of claim 11, wherein at least 60% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 14. The method of claim 11, wherein at least 70% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 15. The method of claim 1, wherein at least 50% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 16. The method of claim 1, wherein at least 60% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject. 17. The method of claim 1, wherein the composition comprising pooled human IgG consists essentially of pooled human IgG and an amino acid selected from the group consisting of glycine, histidine, and proline. 18. The method of claim 1, wherein the composition comprising pooled human IgG is an aqueous composition comprising: (a) from 10 mg/mL to 250 mg/mL pooled human IgG; and (b) from 50 mM to 500 mM glycine. 19. The method of claim 18, wherein the pH of the composition is from 4.0 to 6.0. 20. The method of claim 18, wherein the pH of the composition is from 6.0 to 7.5. 21. The method of claim 1, wherein the composition comprising pooled human IgG is a dry powder composition prepared from an aqueous solution comprising: (a) from 10 mg/mL to 250 mg/mL pooled human IgG; and (b) from 50 mM to 500 mM glycine. 22. The method of claim 21, wherein the dry powder composition is prepared from an aqueous solution having a pH of from 4.0 to 6.0. 23. The method of claim 21, wherein the dry powder composition is prepared from an aqueous solution having a pH of from 6.0 to 7.5. 24. The method of claim 1, wherein the method comprises intranasally administering to the subject a dose of from 0.08 mg to 100 mg pooled human IgG per kg body weight of the subject (mg IgG/kg). 25. The method of claim 1, wherein the method comprises intranasally administering to the subject a fixed dose of from 50 mg to 10 g pooled human IgG. 26. The method of claim 1, wherein the method comprises intranasally administering to the subject a dose of pooled human IgG at least twice monthly. 27. The method of claim 1, wherein at least 70% of the pooled human IgG administered to the subject contacts the nasal epithelium located in the upper third of the nasal cavity of the subject.

Details for Patent 10,144,776

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2033-02-26
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2033-02-26
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2033-02-26
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2033-02-26