# US 10,478,476 B2 · Use of full-length amelogenin for promoting nerve growth or regeneration

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- Number: US 10,478,476 B2
- Document ID: US10478476B2
- Status: Granted
- Kind: B2
- Application number: 15/763,550
- Filed: 2016-09-29
- Published: 2018-09-27
- Granted: 2019-11-19
- Earliest claimed: 2015-09-30
- Assignees: Hadasit Medical Research Services and Development Ltd.; Yissum Research Development Company of the Hebrew University of Jerusalem
- Applicants: Hadasit Medical Research Services and Development Ltd.; Yissum Research Development Company of the Hebrew University of Jerusalem Ltd.
- Inventors: Amir Haze; Anat Blumenfeld; Dan Deutsch
- Web page: https://patentgrep.com/patent/US10478476B2

## CPC

- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61K 38/1825: {Fibroblast growth factor [FGF]}
- A61K 38/185: {Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3}
- A61K 38/1858: {Platelet-derived growth factor [PDGF]}
- A61K 38/30: Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 {(insulin-like growth factor binding protein A61K38/1754)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/02: for peripheral neuropathies
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method of promoting nerve growth or regeneration in a subject in need thereof, wherein the subject is not afflicted with a substantial connective tissue damage, is provided. The method comprises administering to the subject a therapeutically effective amount of full-length amelogenin, thereby promoting nerve growth or regeneration in the subject.

## Claims

### Claim 1

A method of promoting nerve growth or regeneration in a subject in need thereof, the method comprising directly administering to an injured nerve of the subject a therapeutically effective amount of full-length amelogenin, thereby promoting nerve growth or regeneration in the subject, wherein said injured nerve is a peripheral or a spinal cord nerve.

### Claim 2 (depends on 1)

The method of claim 1, wherein the injured nerve is of the peripheral nervous system (PNS).

### Claim 3 (depends on 1)

The method of claim 1, wherein the injured nerve is a spinal cord nerve.

### Claim 4 (depends on 1)

The method of claim 1, wherein the nerve growth or regeneration comprises nerve fiber outgrowth of a neuron, neural progenitor cell, or stem cell.

### Claim 5 (depends on 1)

The method of claim 1, wherein the injured nerve is the sciatic nerve.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject suffers from a disease or condition selected from the group consisting of neuronal injury and a neurodegenerative disease.

### Claim 7 (depends on 6)

The method of claim 6 wherein said subject suffers from a motor neuropathy or peripheral neuropathy.

### Claim 8 (depends on 6)

The method of claim 6, wherein said disease or condition is an injury selected from the group consisting of spinal cord injury, sciatic crush and facial nerve crush.

### Claim 9 (depends on 7)

The method of claim 7, wherein said peripheral neuropathy is selected from the group consisting of diabetic neuropathy, virus-associated neuropathy, botulism-related neuropathy; toxic polyneuropathy, nutritional neuropathy, angiopathic neuropathy, sarcoid-associated neuropathy; carcinomatous neuropathy; compression neuropathy, and hereditary neuropathy.

### Claim 10 (depends on 6)

The method of claim 6, wherein said disease or condition is a neurological injury resulting from a trauma.

### Claim 11 (depends on 10)

The method of claim 10, wherein said trauma is optic nerve trauma or spinal cord trauma.

### Claim 12 (depends on 1)

The method of claim 1, wherein said subject is a mammal.

### Claim 13 (depends on 1)

The method of claim 1, wherein said subject is a human being.

### Claim 14 (depends on 1)

The method of claim 1, further comprising administering to the subject a neurotrophic factor.

### Claim 15 (depends on 14)

The method of claim 14, wherein said neurotrophic factor is selected from nerve growth factor (NGF), insulin-like growth factor (IGF-1), acidic and basic fibroblast growth factor (aFGF and bFGF, respectively), platelet-derived growth factors (PDGF), brain-derived neurotrophic factor (BDNF), ciliary neurotrophic factors (CNTF), glial cell line-derived neurotrophic factor (GDNF), neurotrophin-3(NT-3) and neurotrophin 4/5 (NT-4/5).

### Claim 16 (depends on 1)

The method of claim 1, wherein said amelogenin is human amelogenin.

### Claim 17 (depends on 1)

The method of claim 1, wherein said amelogenin is a recombinant amelogenin expressed from genetically modified cells.

### Claim 18 (depends on 1)

The method of claim 1, wherein said amelogenin is comprised in a scaffold.

### Claim 19 (depends on 15)

The method of claim 15, wherein said insulin-like growth factor (IGF-1) comprises active truncated derivatives thereof selected from the group consisting of gIGF-1 and Des(1-3) IGF-I.

### Claim 20 (depends on 16)

The method of claim 16, wherein said amelogenin is purified amelogenin.

### Claim 21 (depends on 1)

The method of claim 1, wherein said amelogenin is applied directly to a transected axon of said injured nerve.
