# US 9,517,233 B2 · Local cochlear application of statins for stimulating neurite regrowth in the cochlea

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- Number: US 9,517,233 B2
- Document ID: US9517233B2
- Status: Granted
- Kind: B2
- Application number: 14/875,637
- Filed: 2015-10-05
- Published: 2016-01-28
- Granted: 2016-12-13
- Earliest claimed: 2012-12-21
- Assignees: Northwestern University
- Applicants: Northwestern University
- Inventors: Donna S. Whitlon; Claus-Peter Richter
- Web page: https://patentgrep.com/patent/US9517233B2

## CPC

- A61K 31/47: Quinolines; Isoquinolines
- A61K 9/0046: {Ear}
- A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- A61K 31/22: of acyclic acids, e.g. pravastatin
- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/4418: having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
- C07D 309/30: Oxygen atoms, e.g. delta-lactones
- C07D 207/34: with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D 209/24: with an alkyl or cycloalkyl radical attached to the ring nitrogen atom
- C07D 213/55: Acids; Esters
- 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)
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

Statin compositions are disclosed for stimulating neurite growth from spiral ganglion neurons in the inner ear, as well as methods and kits for preventing damage to or treating damage of auditory neurons and/or hair cells of the cochlea following acoustic or toxic insult. An exemplary statin for these methods and kits includes Pitavastatin having the compound formula (VIII):

## Claims

### Claim 1

A method of stimulating neurite growth from spiral ganglion neurons in an inner ear, comprising: contacting a neurite with a statin, or a pharmaceutically acceptable salt thereof, wherein the statin comprises a compound selected from a group consisting of compounds having formulas (II)-(VIII):
or a combination thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the statin comprises a compound having formula (VIII):

### Claim 3 (depends on 1)

The method of claim 1, wherein the contacting step comprises incubating the neurite with a culture medium comprising the statin.

### Claim 4 (depends on 2)

The method of claim 2, wherein the contacting step comprises incubating the neurite with a culture medium comprising the statin.

### Claim 5

A method of preventing or treating hearing loss in a subject, comprising: administering to the subject a statin or a pharmaceutically acceptable salt thereof, wherein the statin comprises a compound selected from a group consisting of compounds having formulas (II)-(VIII):
or a combination thereof.

### Claim 6 (depends on 5)

A method of claim 5, wherein the statin comprises a compound having formula (VIII):

### Claim 7 (depends on 5)

The method of claim 5, wherein the administering step comprises contacting a cochlea of the subject with a pharmaceutical composition of the statin or a pharmaceutically acceptable salt thereof.

### Claim 8 (depends on 6)

The method of claim 6, wherein the administering step comprises contacting a cochlea of the subject with a pharmaceutical composition of the statin or a pharmaceutically acceptable salt thereof.

### Claim 9 (depends on 5)

The method of claim 5, wherein the subject is a human.

### Claim 10 (depends on 6)

The method of claim 6, wherein the subject is a human.

### Claim 11

A kit for preventing or treating hearing loss in a subject, comprising:
a statin comprising a compound selected from a group consisting of compounds having formulas (II)-(VIII):
or a combination thereof; and
instructions for administering to the subject the statin or a pharmaceutically acceptable salt thereof to prevent or treat hearing loss in the subject.

### Claim 12 (depends on 11)

The kit of claim 11, wherein the statin comprises a compound having formula (VIII):

### Claim 13 (depends on 11)

The kit of claim 11, wherein the administering step comprises contacting a cochlea of the subject with a pharmaceutical composition of the statin or a pharmaceutically acceptable salt thereof.

### Claim 14 (depends on 12)

The kit of claim 12, wherein the administering step comprises contacting a cochlea of the subject with a pharmaceutical composition of the statin or a pharmaceutically acceptable salt thereof.

### Claim 15 (depends on 11)

The kit of claim 11, wherein the subject is a human.

### Claim 16 (depends on 12)

The kit of claim 12, wherein the subject is a human.