# US 11,077,179 B2 · Method for treating fibromyalgia and chronic fatigue syndrome

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,077,179 B2
- Document ID: US11077179B2
- Status: Granted
- Kind: B2
- Application number: 16/055,565
- Filed: 2018-08-06
- Published: 2019-02-14
- Granted: 2021-08-03
- Earliest claimed: 2017-08-10
- Assignees: Epicgenetics, Inc.
- Applicants: EpicGenetics, Inc.
- Inventors: Bruce S. Gillis
- Web page: https://patentgrep.com/patent/US11077179B2

## CPC

- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/522: {avirulent or attenuated}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- 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 invention provides methods and compositions for treating fibromyalgia (FM) and chronic fatigue syndrome (CFS) in an individual. The methods provided herein entail administering a composition comprising an isolated Mycobacterium or antigenic fragments derived therefrom. Also provided herein are methods for assessing alleviation of symptoms and/or alteration of immune system functioning following administration of a composition comprising an isolated Mycobacterium or antigenic fragments derived therefrom.

## Claims

### Claim 1

A method of treating fibromyalgia (FM) in a subject, comprising:
(a) determining dysfunction in peripheral blood mononuclear cells (PBMCs), wherein the determining the dysfunction comprises:
(i) stimulating a sample comprising PBMCs obtained from a subject; and
(ii) measuring expression levels of at least four cytokines selected from the group consisting of IL-2, IL-4, IL5, IL6, IL8, IL 10, IFN-γ, RANTES, MCP-1, MIP-α and MIP-β in a PBMC sample obtained from the subject;
(b) comparing the expression levels of the at least four cytokines in the PBMC sample obtained from the subject to the expression levels of the at least four cytokines in a control sample of PBMCs;
(c) diagnosing the subject with FM if dysfunction in PBMCs is detected in the PBMCs obtained from the subject, wherein the dysfunction is indicated by altered expression levels of the at least four cytokines in the PBMC sample obtained from the subject as compared to the expression levels of the at least four cytokines in the control PBMC sample; and
(d) administering a therapeutically effective amount of a vaccine to the subject diagnosed with FM, wherein the vaccine is a live-attenuated or heat-killed Mycobacterium, wherein the Mycobacterium is Mycobacterium bovis (M. bovis), Mycobacterium vaccae (M. vaccae) or Mycobacterium obuense (M. obuense).

### Claim 2 (depends on 1)

The method of claim 1, wherein the vaccine induces one or more epigenetic changes in the genome of the subject.

### Claim 3 (depends on 1)

The method of claim 1, wherein the administration of the vaccine alleviates, prevents or reduces at least one sign or symptom of fibromyalgia, wherein the sign or symptom is selected from chronic muscle pain, muscle spasms, muscle tightness, moderate or severe fatigue, decreased energy, insomnia, feeling of exhaustion, stiffness upon waking, stiffness after staying in one position for too long, difficulty remembering, difficulty concentrating, difficulty performing simple mental tasks (“fibro fog”), abdominal pain, bloating, nausea, constipation alternating with diarrhea (irritable bowel syndrome), tension or migraine headaches, jaw and facial tenderness, sensitivity to one or more of odors, noise, bright lights, medications, certain foods, and cold, feeling anxious or depressed, numbness or tingling in the face, arms, hands, legs, or feet, increase in urinary urgency or frequency (irritable bladder), reduced tolerance for exercise and muscle pain after exercise, a feeling of swelling (without actual swelling) in the hands and feet or any combination of symptoms thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administration of the vaccine elevates or increases immune system activity of the subject.

### Claim 5 (depends on 4)

The method of claim 4, wherein the elevation or increase in immune system function is evidenced by the production of TH1 cytokines, upregulation of granzyme B or both.

### Claim 6 (depends on 1)

The method of claim 1, wherein the PBMCs are isolated from plasma of a blood sample obtained from the subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the PBMCs are stimulated with one or more mitogens.

### Claim 8 (depends on 1)

The method of claim 1, wherein the determined expression level for each of the at least four cytokines is a protein expression level, wherein the protein expression level is determined using an antibody bead-based capture assay that comprises beads derivatized with antibodies specific to the at least four cytokines.

### Claim 9 (depends on 1)

The method of claim 1, wherein the Mycobacterium is M. obuense.

### Claim 10 (depends on 1)

The method of claim 1, wherein the Mycobacterium is M. vaccae.