# US 2013/0156728 A1 · Composition for neurological or autoimmune diseases

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- Number: US 2013/0156728 A1
- Document ID: US20130156728A1
- Status: Published application
- Kind: A1
- Application number: 13/699,605
- Filed: 2011-05-26
- Published: 2013-06-20
- Earliest claimed: 2010-05-26
- Assignees: National Institutes of Health (Nih), U.S. Dept. of Health and Human Services (Dhhs), U.S. Government
- Inventors: Daniel L. Kaufman
- Web page: https://patentgrep.com/patent/US20130156728A1

## CPC

- A61K 39/07: Bacillus
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- 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
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- 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

## Abstract

The present invention provides a composition effective for a neurological disease or an autoimmune disease and methods of making and using the same.

## Claims

### Claim 1

A composition, which is a vaccine composition or a pharmaceutical composition, comprising an effective amount of Bacillus Calmette-Guerin (BCG) and an optional second agent, wherein the composition is effective for inhibiting the progress of a neurological disease or causing a neurological disease to progress at a slower rate.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the second agent is effective for Parkinson's disease (PD).

### Claim 3 (depends on 1)

The composition of claim 1, wherein the second agent is an enzyme, a peptide, a compound or a combination of these.

### Claim 4 (depends on 3)

The composition of claim 3, wherein the enzyme is glutamic acid decarboxylase 65 (GAD65), glutamic acid decarboxylase 67 (GAD67), and wherein the peptide is a GAD peptide.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the neurological disease is selected from the group consisting of PD, Alzheimer's disease, and amyotrophic lateral sclerosis.

### Claim 6 (depends on 1)

The composition of claim 1, further comprising an adjuvant.

### Claim 7 (depends on 1)

The composition of claim 1, comprising the second agent and further an excipient,
wherein the composition comprises:
a formulation comprising the BCG; and
a formulation comprising the second agent.

### Claim 8 (depends on 7)

The composition of claim 7, wherein the excipient comprises a pharmaceutically acceptable carrier.

### Claim 9 (depends on 1)

The composition of claim 1 in a formulation for systemic delivery or local delivery.

### Claim 10 (depends on 7)

The composition of claim 7, wherein the formulation comprising the second agent is a formulation for fast release or sustained release.

### Claim 11 (depends on 8)

The composition of claim 8, wherein the formulation comprising the second agent is a formulation for fast release or sustained release.

### Claim 12 (depends on 1)

The composition of claim 1 in a formulation for oral delivery, inhalation, injection, implant, topical delivery, or transdermal delivery.

### Claim 13 (depends on 1)

The composition of claim 1, comprising the second agent, the second agent comprising an effective amount of an immunostimulatory factor that simulates a typical host response to BCG infection.

### Claim 14 (depends on 13)

The composition of claim 13, wherein the immunostimulatory factor is an inflammatory cytokine.

### Claim 15 (depends on 13)

The composition of claim 13, wherein the immunostimulatory factor is selected from the group consisting of IFNgamma, IL2β, IL-6, IL-32, IL-24 and combinations thereof.

### Claim 16 (depends on 1)

The composition of claim 1, comprising the second agent, the second agent comprising an effective amount of a compound that simulates a BCG infection.

### Claim 17 (depends on 17)

The composition of claim 17, wherein the compound binds to TLR-4 or TLR-2.

### Claim 18 (depends on 17)

The composition of claim 17, wherein the compound is selected from the group consisting of agonists of receptors binding to TLR-4 or TLR-2 and antibodies that activate these receptors.

### Claim 19 (depends on 1)

The composition of claim 1, comprising the second agent, the second agent comprising an effective amount of a compound that activates the signaling pathways used by TLR-4, TLR-2, IFNgamma, IL2β, IL-6, IL-32 and IL-24.

### Claim 20 (depends on 1)

A method, comprising forming a composition according to claim 1.

### Claim 21 (depends on 1)

A method of treating, preventing, or ameliorating a neurological disease or an autoimmune disease, comprising:
administering to a subject a composition according to claim 1.

### Claim 22 (depends on 21)

The method according to claim 21, wherein the neurological disease is selected from the group consisting of PD, Alzheimer's disease, and amyotrophic lateral sclerosis.