# US 10,245,314 B2 · Non-specific delayed-type hypersensitivity response to treat herpes simplex virus infection

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- Number: US 10,245,314 B2
- Document ID: US10245314B2
- Status: Granted
- Kind: B2
- Application number: 15/681,393
- Filed: 2017-08-20
- Published: 2017-11-30
- Granted: 2019-04-02
- Earliest claimed: 2015-02-26
- Assignees: Squarex, LLC
- Applicants: Squarex, LLC
- Inventors: Hugh McTavish
- Web page: https://patentgrep.com/patent/US10245314B2

## CPC

- A61K 39/245: Herpetoviridae, e.g. herpes simplex virus
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 31/04: Nitro compounds
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/215: of carboxylic acids
- A61K 35/763: Herpes virus
- A61K 39/12: Viral antigens
- A61K 39/165: Mumps or measles virus
- A61P 17/00: Drugs for dermatological disorders
- A61P 31/22: for herpes viruses
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/035: Herpes simplex virus I or II
- G01N 33/571: for venereal disease, e.g. syphilis, gonorrhoea {(herpes G01N33/56994; chlamydia G01N33/56927)}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55511: {Organic adjuvants}
- C12N 2710/16611: Simplexvirus, e.g. human herpesvirus 1, 2
- 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
- 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)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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:
an administering step comprising:
applying a topical immunosensitizer to the skin of a person infected with HSV at a time when the person is not having an HSV outbreak, or applying a topical immunosensitizer to the skin of a person infected with HSV during an HSV outbreak wherein the applying is at a site other than a site of an HSV lesion;
wherein the method does not further comprise (i) applying a topical immunosensitizer to the skin of a person infected with HSV on an HSV lesion at a time of an HSV outbreak in the person; or (ii) intradermally injecting a recall antigen into a person infected with HSV in an HSV lesion at the time of an HSV outbreak in the person;
wherein the method reduces the frequency of HSV outbreaks in the person after the administering step;
wherein the person has had HSV outbreaks before the administering step and is in recognized need of treatment for HSV infection;
wherein the administering step comprises applying the topical immunosensitizer to skin on the forearm or on the inner aspect of the upper arm of the person;
wherein the topical immunosensitizer comprises squaric acid dibutyl ester (SADBE); and
wherein the person has herpes labialis.

### Claim 2 (depends on 1)

The method of claim 1 wherein the administering step comprises applying the topical immunosensitizer to skin on the inner aspect of the upper arm of the person.

### Claim 3 (depends on 1)

The method of claim 1 wherein the topical immunosensitizer is applied as a solution in DMSO.

### Claim 4 (depends on 1)

The method of claim 1 wherein the HSV is HSV-1.

### Claim 5 (depends on 1)

The method of claim 1 wherein the HSV is HSV-2.

### Claim 6 (depends on 1)

The method of claim 1 wherein the method increases time between outbreaks by at least 2-fold.

### Claim 7 (depends on 1)

The method of claim 1 wherein the method increases 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 8 (depends on 1)

The method of claim 1 wherein the method increases median time to the next outbreak after the administering step by at least 2-fold.

### Claim 9 (depends on 1)

The method of claim 1 wherein the method increases median time from day 21 following the administering step to the next outbreak that begins at least 21 days after the administering step by at least 2-fold.

### Claim 10 (depends on 1)

The method of claim 1 wherein the method further comprises a second administering step comprising:
(a) applying a topical immunosensitizer to the skin of a person infected with HSV at a time when the person is not having an HSV outbreak, or applying a topical immunosensitizer to the skin of a person infected with HSV during an HSV outbreak wherein the applying is at a site other than a site of an HSV lesion.

### Claim 11 (depends on 10)

The method of claim 10 wherein the second administering step occurs 7 days to 30 days after the first administering step.

### Claim 12 (depends on 10)

The method of claim 10 wherein the second administering step occurs 7 days to 365 days after the first administering step and occurs at a time when the person is having an HSV outbreak.