# US 12,599,617 B2 · Methods of treating head and neck cancers with hemp extract

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- Number: US 12,599,617 B2
- Document ID: US12599617B2
- Status: Granted
- Kind: B2
- Application number: 18/049,966
- Filed: 2022-10-26
- Published: 2023-04-27
- Granted: 2026-04-14
- Earliest claimed: 2021-10-26
- Assignees: Dove Innovation Pty Limited
- Applicants: Ecofibre USA Inc.; The University of Newcastle
- Inventors: Alexandra M. Capano; Pradeep Singh Tanwar; Alex Nance
- Web page: https://patentgrep.com/patent/US12599617B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/282: Platinum compounds
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 33/243: Platinum; Compounds thereof
- A61K 36/3482: {Cannabis}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- 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

A method for treating a head or neck cancer comprising: administering to a patient an effective amount of a composition comprising a cannabis extract comprising cannabidiol (CBD), wherein the composition is preferably administered as a mucosal formulation.

## Claims

### Claim 1

A method for treating head and neck cancer comprising administering to a patient an effective amount of a composition comprising a cannabis extract (CE) comprising between 50% and 99.9% cannabidiol (CBD) by weight and wherein the composition has a pH of between 2 and 5.5.

### Claim 2 (depends on 1)

The method of claim 1 wherein the CE is selected from the group consisting of: a full spectrum hemp extract (FSHE), a broad spectrum hemp extract (BSHE), and a CBD isolate.

### Claim 3 (depends on 1)

The method of claim 1 wherein the CE is administered via an oral form, oral mucosal form, intravaginal form, nasal mucosal form, rectal form, injectable form, or combinations thereof.

### Claim 4 (depends on 1)

The method of claim 1 wherein the effective amount of the cannabis extract comprising CBD comprises between 10 mg and 4,250 mg of CBD per day.

### Claim 5 (depends on 1)

The method of claim 1 wherein administration of the CE is a dose given at least once a day, at least twice a day, or at least three times a day.

### Claim 6 (depends on 1)

The method of claim 1 wherein the head and neck cancer is a grade 1, grade 2, or grade 3 cancer.

### Claim 7 (depends on 1)

The method of claim 1 wherein the head and neck cancer is a chemoresistant head and neck cancer.

### Claim 8 (depends on 1)

The method of claim 1 wherein the CE further comprises CBDA at a concentration of between 0.1% and 10%.

### Claim 9 (depends on 1)

The method of claim 1 wherein the CE is a BSHE or FSHE and wherein each of the BSHE or FSHE comprises 50% to 99.9% by weight of CBD and at least one other cannabinoid at a concentration of 0.1% to 10% by weight wherein the at least one other cannabinoid is selected from the group consisting of: Δ-9-tetrahydrocannabinol (Δ9-THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), Δ-8-tetrahydrocannabinol (Δ8-THC), cannabichromene (CBC), cannabichromene acid (CBCA), cannabigerol (CBG), cannabigerol acid (CBGA), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabinol (CBN), cannabicyclol (CBL), and combinations thereof.

### Claim 10 (depends on 1)

The method of claim 1 wherein the composition comprises at least one additional compound selected from the group consisting of: a terpene, a polyphenol, an essential fatty acid, a phytonutrient, and combinations thereof; and wherein the at least one additional compound makes up between 0.1% and 50% by weight of the total weight of the composition.

### Claim 11 (depends on 1)

The method of claim 1 wherein the composition comprises an oil or a fat as a carrier.

### Claim 12 (depends on 1)

The method of claim 1 wherein the effective amount of the composition is an amount sufficient to reach an effective therapeutic level of CBD as measured through systemic plasma levels.

### Claim 13

A method of treatment of head and neck cancer comprising administering to a patient an effective amount of a chemotherapeutic agent and coadministering an effective amount of an oral mucosal composition comprising a cannabis extract (CE) comprising between 50% and 99.9% cannabidiol (CBD) by weight and wherein the composition has a pH of between 2 and 5.5.

### Claim 14 (depends on 13)

The method of claim 13 wherein the chemotherapeutic agent and the CE are administered as one composition or as two different compositions.

### Claim 15 (depends on 13)

The method of claim 13 wherein the chemotherapeutic agent is selected from the group consisting of: paclitaxel, carboplatin, doxorubicin, cisplatin, docetaxel, fluorouracil, methotrexate, cetuximab, and combinations thereof.

### Claim 16 (depends on 13)

The method of claim 13 wherein the effective amount of the composition is sufficient to reach an effective therapeutic level as measured through systemic plasma levels of CBD.

### Claim 17

A method for treating a head and neck cancer comprising administering to a patient an effective amount of a composition, said composition comprising a carrier and a cannabis extract (CE) comprising cannabidiol (CBD), said composition comprising between 50% and 99.9% CBD by weight, and wherein the composition has a pH of between 2 and 5.5.
