# US 2021/0172016 A1 · Dosage and varietal recommendations for the treatment of medical conditions using cannabis

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- Number: US 2021/0172016 A1
- Document ID: US20210172016A1
- Status: Published application
- Kind: A1
- Application number: 16/762,289
- Filed: 2018-11-07
- Published: 2021-06-10
- Earliest claimed: 2017-11-07
- Assignees: MedReleaf Corp.
- Applicants: MedReleaf Corp.
- Inventors: Angelo Fefekos; Shannon Theresa Louise O'Hearn; George Shawn Charames
- Web page: https://patentgrep.com/patent/US20210172016A1

## CPC

- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- C12Q 1/6883: for diseases caused by alterations of genetic material
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)

## Abstract

Described are methods for determining a recommended dosage and/or variety of cannabis for a subject based on genetic testing. The presence or absence of genetic variants in a sample from the subject is determined and used to determine a recommended dosage of cannabis, estimate the sensitivity of the subject to cannabis, or select a subject for the treatment of a medical condition. In some embodiments the genetic variants include polymorphisms in or near CYP2C9, CYP3A4 and/or CYP2C19, optionally that are associated with cannabinoid metabolism. The recommended dosage may be for a specific variety of cannabis for treating a medical condition.

## Claims

### Claim at position 1

-44. (canceled)

### Claim 45

A method of determining a sensitivity of a subject to one or more cannabinoids, the method comprising:
testing nucleic acid from the subject to determine the presence or absence of a genetic variant that modifies the expression and/or activity of one or more of the wild-type CYP2C9, CYP3A4, and CYP2C19 genes, wherein the genetic variant comprises any one or more of the genetic variants identified in Tables 1, 2, and 3.

### Claim 46 (depends on 45)

The method according to claim 45, wherein the presence or absence of the genetic variant indicates a sensitivity to cannabidiol (CBD).

### Claim 47 (depends on 45)

The method according to claim 45, wherein the presence or absence of the genetic variant indicates a sensitivity to tetrahydrocannabinol (THC).

### Claim 48 (depends on 46)

The method according to claim 46, wherein the genetic variant comprises one or more of the genetic variants identified in Tables 1 and 3.

### Claim 49 (depends on 48)

The method according to claim 48, wherein the genetic variant modifies the expression and/or activity of the CYP2C19 gene and indicates a decreased, a deleterious, or an increased effect on CBD metabolism.

### Claim 50 (depends on 49)

The method according to claim 49, wherein the genetic variant comprises one or more of rs12769205, rs17884712, rs6413438, rs192154563, rs140278421, rs118203757, and rs118203759.

### Claim 51 (depends on 48)

The method according to claim 48, wherein the genetic variant modifies the expression and/or activity of the CYP3A4 gene and indicates a decreased or a deleterious effect on CBD metabolism.

### Claim 52 (depends on 51)

The method according to claim 51, wherein the genetic variant comprises one or more of rs55785340, rs72552799, rs12721629, rs67666821, rs35599367, rs67784355, rs4986909, rs12721627, rs4987161, and rs138105638.

### Claim 53 (depends on 47)

The method according to claim 47, wherein the genetic variant comprises one or more of the genetic variants identified in Tables 1 and 2.

### Claim 54 (depends on 53)

The method according to claim 53, wherein the genetic variant modifies the expression and/or activity of the CYP2C9 gene and indicates a decreased or a deleterious effect on THC metabolism.

### Claim 55 (depends on 54)

The method according to claim 54, wherein the genetic variant comprises one or more of rs7900194, rs9332239, rs56165452, rs72558187, rs72558190, and rs72558188.

### Claim 56 (depends on 54)

The method according to claim 54, wherein the genetic variant modifies the expression and/or activity of the CYP3A4 gene and indicates a decreased or a deleterious effect on THC metabolism.

### Claim 57 (depends on 56)

The method according to claim 56, wherein the genetic variant comprises one or more of rs55785340, rs72552799, rs12721629, rs67666821, rs35599367, rs67784355, rs4986909, rs12721627, rs4987161, and rs138105638.

### Claim 58 (depends on 45)

The method according to claim 45, wherein the absence of the genetic variant indicates a normal sensitivity to the one or more cannabinoids.

### Claim 59 (depends on 45)

The method according to claim 45, further comprising generating a cannabis compatibility score based on the presence or absence of the genetic variant.

### Claim 60 (depends on 59)

The method according to claim 59, further comprising comparing the cannabis compatibility score to one or more control scores to determine one or more of a cannabinoid dose, a cannabinoid dosage, and a cannabis variety to prescribe to the subject.

### Claim 61 (depends on 45)

An allele-specific polynucleotide suitable for determining the sensitivity of the subject to one or more cannabinoids according to the method of claim 45, wherein the polynucleotide is specific for the genetic variant that modifies the expression and/or activity of one or more of the wild-type CYP2C9, CYP3A4, and CYP2C19 genes.

### Claim 62 (depends on 61)

A kit comprising at least one allele-specific polynucleotide defined in claim 61 and at least one further component, wherein the at least one further component is a buffer, a deoxynucleotide triphosphate (dNTP), an amplification primer pair, an enzyme, or any combination thereof.

### Claim 63 (depends on 1)

The method of claim 1, further comprising treating the subject for a medical condition with the one or more cannabinoids, wherein the medical condition comprises one or more of anxiety, appetite disorder, depression, inflammation, pain, nausea, vomiting, seizures, and sleep.

### Claim 64

A method of determining a sensitivity of a subject to one or more cannabinoids for the treatment of pain, the method comprising:
testing nucleic acid from the subject to determine the presence or absence of a genetic variant that modifies the expression and/or activity of one or more of the wild-type CYP2C9, CYP3A4, and CYP2C19 genes, wherein the genetic variant comprises any one or more of the genetic variants identified in Tables 15 and 16.

### Claim 65 (depends on 64)

The method according to claim 64, wherein the presence or absence of any one or more of the genetic variants identified in Table 15 indicates a responsiveness of the subject to treating pain with CBD.

### Claim 66 (depends on 64)

The method according to claim 64, wherein the presence or absence of any one or more of the genetic variants identified in Table 16 indicates a responsiveness of the subject to treating pain with THC.
