# US 2023/0265167 A1 · Compositions having neuroregenerative applications

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- Number: US 2023/0265167 A1
- Document ID: US20230265167A1
- Status: Published application
- Kind: A1
- Application number: 18/004,233
- Filed: 2021-07-07
- Published: 2023-08-24
- Earliest claimed: 2020-07-08
- Assignees: Grifols Worldwide Operations Limited
- Applicants: Grifols Worldwide Operations Limited
- Inventors: Thomas BARNETT; David A. ROSS
- Web page: https://patentgrep.com/patent/US20230265167A1

## CPC

- A61P 25/00: Drugs for disorders of the nervous system
- C07K 14/79: Transferrins, e.g. lactoferrins, ovotransferrins
- A61K 31/4409: only substituted in position 4, e.g. isoniazid, iproniazid
- A61K 31/551: having two nitrogen atoms, e.g. dilazep
- A61K 38/1709: {from mammals}
- A61K 38/1841: {Transforming growth factor [TGF]}
- 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 38/2278: {Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)}
- A61K 38/40: Transferrins, e.g. lactoferrins, ovotransferrins
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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)

## Abstract

Pharmaceutical compositions containing transferrin and, or lactoferrin for use in promoting and or inducing the generation new neural cells in a patient that has suffered a neurodegenerative event arising from at least one of a traumatic brain injury, a non-traumatic brain injury, a spinal cord injury, a peripheral nerve injury, or peripheral neuropathy. Ideally, the transferrin and/or lactoferrin have a low iron saturation.

## Claims

### Claim 1

A method of promoting and/or inducing generation of new neural cells in a patient that has suffered a neurodegenerative event arising from at least one of a traumatic brain injury, a non-traumatic brain injury, a spinal cord injury, a peripheral nerve injury, or peripheral neuropathy,
the method comprising administering a therapeutically effective amount of a protein selected from transferrin, lactoferrin, and combinations thereof to the patient in need thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of transferrin or lactoferrin administered to the patient has an iron saturation of less than about 20%.

### Claim 3 (depends on 1)

The method of claim 1, wherein the protein is human transferrin.

### Claim 4 (depends on 1)

The method of claim 1, wherein the transferrin is plasma-derived or recombinant.

### Claim 5 (depends on 4)

The method of claim 4, wherein the recombinant transferrin is a mutant transferrin selected from the group consisting of:
i) Y188F mutant comprising the amino acid sequence set forth in SEQ ID NO: 3;
ii) Y95F/Y188F mutant comprising the amino acid sequence set forth in SEQ ID NO: 4;
iii) Y426F/Y517F mutant comprising the amino acid sequence set forth in SEQ ID NO: 5; and
iv) combinations thereof.

### Claim 6 (depends on 1)

The method of claim 1, wherein the transferrin is a domain of a fusion protein, and the fusion partner is an immunoglobulin Fc domain.

### Claim 7 (depends on 1)

The method of claim 1, wherein the traumatic brain injury or spinal cord injury is caused by at least one of road a traffic accident, an assault, a sporting collision, or an unprotected fall.

### Claim 8 (depends on 1)

The method of claim 1, wherein the non-traumatic brain injury is caused by at least one of an ischaemic stroke, a haemorrhagic stroke, cerebral hypoxia, cerebral anoxia, consumption of chemical toxins, hydrocephalus, meningitis, or encephalitis.

### Claim 9 (depends on 1)

The method of claim 1, wherein the neurodegenerative event arises from a stroke selected from the group consisting of a ischemic stroke and a haemorrhagic stroke.

### Claim 10 (depends on 1)

The method of claim 1, further comprising administering a serum or plasma protein selected from the group consisting of Albumin, Alpha-1 Antitrypsin/Alpha-1 Proteinase Inhibitor, Antithrombin, polyclonal immunoglobulins, polyspecific immunoglobulins, C1 esterase inhibitor, Transthyretin, and combinations thereof to the patient in addition to the protein selected from transferrin, lactoferrin, and combinations thereof.

### Claim at position 11

11-21. (canceled)

### Claim 22

A method of stimulating neural cell development in a patient that has suffered a neurodegenerative event arising from at least one of a traumatic brain injury, a non-traumatic brain injury, a spinal cord injury, a peripheral nerve injury, or peripheral neuropathy,
the method comprising administering a therapeutically effective amount of a protein selected from transferrin, lactoferrin, and combinations thereof to the patient in need thereof.

### Claim 23 (depends on 2)

The method of claim 2Z wherein the therapeutically effective amount of transferrin or lactoferrin administered to the patient has an iron saturation of less than about 20%.

### Claim 24 (depends on 22)

The method of claim 22, wherein the protein is human transferrin.

### Claim 25 (depends on 22)

The method of claim 22, wherein the transferrin is plasma derived or recombinant.

### Claim 26 (depends on 25)

The method of claim 25, wherein the recombinant transferrin is a mutant transferrin selected from the group consisting of:
v) Y188F mutant comprising the amino acid sequence set forth in SEQ ID NO: 3;
vi) Y95F/Y188F mutant comprising the amino acid sequence set forth in SEQ ID NO: 4;
vii) Y426F/Y517F mutant comprising the amino acid sequence set forth in SEQ ID NO: 5; and
viii) combinations thereof.

### Claim 27 (depends on 22)

The method of claim 22, wherein the transferrin is a domain of a fusion protein, and the fusion partner is an immunoglobulin Fc domain.

### Claim 28 (depends on 22)

The method of claim 22, wherein the traumatic brain injury or spinal cord injury is caused by at least one of road a traffic accident, an assault, a sporting collision, or an unprotected fall.

### Claim 29 (depends on 22)

The method of claim 22, wherein the non-traumatic brain injury is caused by at least one of an ischaemic stroke, a haemorrhagic stroke, cerebral hypoxia, cerebral anoxia, consumption of chemical toxins, hydrocephalus, meningitis, or encephalitis.

### Claim 30 (depends on 22)

The method of claim 22, wherein the neurodegenerative event arises from a stroke selected from the group consisting of a ischemic stroke and a haemorrhagic stroke.

### Claim 31 (depends on 22)

The method of claim 22, further comprising administering a serum or plasma protein selected from the group consisting of Albumin, Alpha-1 Antitrypsin/Alpha-1 Proteinase Inhibitor, Antithrombin, polyclonal immunoglobulins, polyspecific immunoglobulins, C1 esterase inhibitor, Transthyretin, and combinations thereof to the patient in addition to the protein selected from transferrin, lactoferrin, and combinations thereof.

### Claim at position 22

32-42. (canceled)