# US 2016/0081918 A1 · Non-specific delayed-type hypersensitivity response to treat herpes simplex virus infection

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- Number: US 2016/0081918 A1
- Document ID: US20160081918A1
- Status: Published application
- Kind: A1
- Application number: 14/960,402
- Filed: 2015-12-06
- Published: 2016-03-24
- Earliest claimed: 2007-04-04
- Assignees: Squarex, LLC; The Board of Trustees of the University of Arkansa
- Applicants: Squarex, LLC; The Board of Trustees of the University of Arkansa
- Inventors: Hugh McTavish; Thomas Dag Horn; Sandra Marchese Johnson
- Web page: https://patentgrep.com/patent/US20160081918A1

## CPC

- 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 31/04: Nitro compounds
- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/08: acyclic, e.g. paraformaldehyde
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/13: Amines {(A61K31/04 takes precedence)}
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61K 39/165: Mumps or measles virus
- A61P 31/12: Antivirals
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- 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}
- C12N 2760/18733: Use of viral protein as therapeutic agent other than vaccine, e.g. apoptosis inducing or anti-inflammatory
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A method is presented for treating herpes simplex virus (HSV) infection comprising: (a) locally administering a substance that induces a delayed type hypersensitivity (DTH) response to a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion during one or more outbreaks of the HSV infection.

## Claims

### Claim 1

A method of treating herpes simplex virus (HSV) infection comprising:
(a) locally administering a substance that induces a delayed type hypersensitivity (DTH) response to a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion during one or more outbreaks of the HSV infection;
wherein the method reduces the frequency or severity of subsequent HSV outbreaks in the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein the method reduces the severity of subsequent outbreaks.

### Claim 3 (depends on 1)

The method of claim 1 wherein the method increases time between outbreaks.

### Claim 4 (depends on 1)

The method of claim 1 wherein step (a) comprises topically applying the substance that induces a DTH response to a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion.

### Claim 5 (depends on 4)

The method of claim 4 wherein the substance that induces a DTH response is not squaric acid, a squaric acid ester, diphenylcyclopropenone (DPCP), 1-chloro-2,4-dinitrobenzene (DNCB), or 1-chloro-2,6-dinitrobenzene.

### Claim 6

(canceled)

### Claim 7 (depends on 4)

The method of claim 4 wherein the substance that induces a DTH response comprises urushiol or an extract of an irritating plant.

### Claim 8 (depends on 1)

The method of claim 1 wherein step (a) comprises intralesionally injecting the substance that induces a DTH response into a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion.

### Claim 9 (depends on 8)

The method of claim 8 wherein the substance that induces a DTH response comprises mumps antigen, candida antigen, or trichophyton antigen.

### Claim 10 (depends on 1)

The method of claim 1 further comprising before step (a) administering the substance that induces a DTH response to the patient to develop a sensitivity to the substance in the patient.

### Claim 11

(canceled)

### Claim 12 (depends on 1)

The method of claim 1 wherein the herpes simplex virus is HSV type 1.

### Claim 13 (depends on 1)

The method of claim 1 wherein the herpes simplex virus is HSV type 2.

### Claim 14 (depends on 1)

The method of claim 1 wherein step (a) comprises administering the substance that induces a DTH response at the site of an HSV lesion on or adjacent to the lip of the patient.

### Claim 15 (depends on 1)

The method of claim 1 wherein step (a) comprises administering the substance that induces a DTH response at the site of an HSV lesion on the genitals of the patient.

### Claim at position 16

16-17. (canceled)

### Claim 18 (depends on 1)

The method of claim 1 further comprising:
(b) locally administering an immune response enhancer to the patient at the site of the HSV lesion before or during the DTH response at the site of the lesion.

### Claim 19 (depends on 18)

The method of claim 18 wherein the immune response enhancer is a cytokine.

### Claim at position 19

20-21. (canceled)

### Claim 22 (depends on 18)

The method of claim 18 wherein the immune response enhancer is imiquimod or resiquimod.

### Claim 23 (depends on 1)

The method of claim 1 wherein the method decreases time to healing of lesions in a subsequent outbreak of the HSV infection after step (a) by at least 30%.

### Claim 24 (depends on 1)

The method of claim 1 wherein the method increases time between outbreaks by at least 4-fold.

### Claim 25 (depends on 1)

The method of claim 1 wherein the method at least doubles stimulation index of peripheral blood mononuclear cells (PBMC) from a patient in a proliferation test with stimulation of proliferation by killed HSV particles as compared to the stimulation index of PBMC from the patient before treatment.

### Claim 26 (depends on 1)

The method of claim 1 wherein the method comprises:
(a) locally administering a substance that induces a delayed type hypersensitivity (DTH) response to a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion during one outbreak of the HSV infection;
wherein the method does not comprise administering a substance that induces a DTH response to the patient at a site of an HSV lesion to induce a DTH response at the site of the lesion during another outbreak within 3 months before or after the one outbreak.

### Claim 27 (depends on 1)

The method of claim 1 wherein the method comprises:
(a) locally administering a substance that induces a delayed type hypersensitivity (DTH) response to a patient at a site of an HSV lesion to induce a DTH response at the site of the lesion during two or more outbreaks of the HSV infection within 6 months.

### Claim 28

A medical use of a substance capable of inducing a delayed-type hypersensitivity (DTH) response in humans to prepare a medicament effective to reduce the frequency or severity of subsequent herpes simplex virus (HSV) outbreaks in a patient with HSV infection.

### Claim 29 (depends on 17)

The medical use of claim 17 wherein the substance is a topical contact sensitizer capable of inducing a DTH response in humans when administered topically.

### Claim 30 (depends on 17)

The medical use of claim 17 wherein the substance is an antigen capable of inducing a DTH response in humans when injected intradermally.