# US 11,305,022 B2 · Methods for distributing high levels of therapeutic agent throughout the cortex to treat neurological disorders

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- Number: US 11,305,022 B2
- Document ID: US11305022B2
- Status: Granted
- Kind: B2
- Application number: 13/146,640
- Filed: 2010-01-29
- Published: 2012-02-02
- Granted: 2022-04-19
- Earliest claimed: 2009-01-29
- Assignees: The Regents of the University of California
- Applicants: Krystof Bankiewicz; Adrian P. Kells
- Inventors: Krystof Bankiewicz; Adrian P. Kells
- Web page: https://patentgrep.com/patent/US11305022B2

## CPC

- A61K 48/0075: {characterised by an aspect of the delivery route, e.g. oral, subcutaneous}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/26: Psychostimulants, e.g. nicotine, cocaine
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- C12N 15/86: Viral vectors
- C12N 2750/14143: viral genome or elements thereof as genetic vector
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention provides methods for treating neurological disorders, which involve administering therapeutic agents to the thalamus by convection enhanced delivery.

## Claims

### Claim 1

A method for delivering an Adeno Associated Virus (AAV) therapeutic agent to neurons of the cerebral cortex in a primate by anterograde transport from the thalamus, comprising administering said AAV therapeutic agent into the thalamus of said primate by convection enhanced delivery (CED) at an infusion rate greater than 0.5 μl/min, thereby delivering the AAV therapeutic agent to neurons of multiple cortical layers of the primate cerebral cortex.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said AAV therapeutic agent is administered to more than one location in the thalamus.

### Claim 3 (depends on 2)

The method according to claim 2, wherein more than one cannula is used to administer said AAV therapeutic agent.

### Claim 4 (depends on 1)

The method according to claim 1, comprising repeated administration of said AAV therapeutic agent.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said AAV therapeutic agent is delivered to more than one functional area of the cerebral cortex.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said AAV therapeutic agent is delivered to more than one lobe of the cerebral cortex.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said AAV therapeutic agent is an AAV particle comprising a nucleic acid encoding a therapeutic protein.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said method comprises delivering the AAV therapeutic agent to cortical layers II, III, and/or IV.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said AAV is selected from the group consisting of AAV2, AAV3, AAV4, AAV5, AAV7, AAV8, and AAV9.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the CED comprises an infusion rate greater than 0.7 μl/min.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the method comprises delivering the AAV therapeutic agent to neurons of more than one lobe of the cerebral cortex.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the method comprises delivering the AAV therapeutic agent to neurons of Cortical Areas 9 and 10 and to neurons of any one of Cortical Area 6; Cortical Areas 3, 1, or 2; or Cortical Area 4.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the method comprises delivering the AAV therapeutic agent to neurons of Cortical Areas 1, 2, 3, 4, 6, 8, 9, and 10.