WO2019090421A1 – May 16, 2019 – DOSAGE AND VARIETAL RECOMMENDATIONS FOR THE TREATMENT OF MEDICAL CONDITIONS USING CANNABIS

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Inventors :

FEFEKOS, Angelo - 401 Coombs Court, Milton, Ontario L9T 7N5; O'HEARN, Shannon Theresa Louise - 38 Browning Avenue, Toronto, Ontario M4K 1V7; CHARAMES, George Shawn - 67 Gledhill Avenue, Toronto, Ontario M4C 5K7

Owner :

MEDRELEAF CORP.

Application Number :

WOCA18051406

Document Number :

WO2019090421A1

Priority Date :

January 1, 1970

Filing Date :

November 7, 2018

Date of Grant/ Publication :

May 16, 2019

Class :

; C12Q1 / 6809; A61K31 / 05; A61K31 / 352; A61P29 / 00; C07C39 / 23; C07D311 / 80; C12Q1 / 68; C12Q1 / 6876; G01N33 / 48

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.

Claim(s)

1 . A method of determining a recommended dosage and/or variety of cannabis for treating a subject with a medical condition, the method comprising: determining the presence or absence of one or more genetic variants in a sample from the subject; determining a recommended variety of cannabis for the subject based on the medical condition of the subject; determining a recommended dosage of the recommended variety of cannabis for the subject based on the presence or absence of the one or more genetic variants in the sample. 2. The method of claim 1 , further comprising determining the recommended dosage of the recommended variety of cannabis for the subject based on the presence or absence of the one or more genetic variants in the sample and the medical condition of the subject. 3. The method of claim 1 or 2, wherein determining the recommended dosage for the subject comprises: generating a cannabis compatibility score for the subject based on the presence or absence of the one or more genetic variants; and comparing the cannabis compatibility score to one or more control scores, wherein each control score is associated with a recommended dosage.;
4. The method of claim 3, wherein each control score is associated with a recommended dosage for the treatment of the medical condition.;
5. The method of any one of claims 1 to 4, wherein the medical condition is anxiety, appetite disorder, depression, inflammation, pain, nausea and/or vomiting, seizures, or a sleep disorder. 6. The method of claim 5, wherein the medical condition is anxiety and the recommended variety is Midnight MR , Avidekel MR or Luminarium MR .;
7. The method of claim 5, wherein the medical condition is an appetite disorder and the recommended variety is Cognitiva MR , Sedamen MR or Eran Almog MR .;
8. The method of claim 5, wherein the medical condition is depression and the recommended variety is Midnight MR , Luminarium MR or Avidekel MR . 9. The method of claim 5, wherein the medical condition is inflammation and the recommended variety is Avidekel MR , Midnight MR or Nollia MR .;
10. The method of claim 5, wherein the medical condition is pain and the recommended variety is Midnight MR , Luminarium MR , Avidekel MR or Sedamen MR .;
1 1 . The method of claim 5, wherein the medical condition is nausea and/or vomiting and the recommended variety is Midnight MR , Sedamen MR or Avidekel MR .;
12. The method of claim 5, wherein the medical condition is seizures and the recommended variety is Avidekel MR or Midnight MR .;
13. The method of claim 5, wherein the medical condition is a sleep disorder, and the recommended variety is Midnight MR , Sedamen MR or Eran Almog MR .;
14. The method of any one of claims 1 to 13, wherein at least one of the genetic variants is associated with cannabinoid metabolism.;
15. The method of any one or claims 1 to 14, wherein at least one of the genetic variants is a genetic variant in CYP2C19 listed in Table 1 , a genetic variant in CYP2C9 listed in Table 2 or a genetic variant in CYP3A4 listed in Table 3.;
16. The method of any one of claims 1 to 15, wherein the one or more genetic variants comprise at least 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, or 15 of the genetic variants listed in Table 10.;
17. The method of any one of claims 1 to 16, wherein the recommended variety of cannabis is for cannabis that contains a therapeutically effective amount of THC and the method comprises determining the presence of absence of genetic variants associated with THC metabolism, optionally variants in CYP2C9 and/or CYP3A4.;
18. The method of claim 17, wherein the recommended dosage of cannabis is a low daily dose, a medium daily dose or a high daily dose.;
19. The method of claim 17 or 18 wherein the recommended dosage of cannabis is for inhalation, such as by smoking or vaping, and the low daily dose is less than 343 mg of THC per day, the medium daily dose is between 343 and 573 mg of THC per day, and the high daily dose is greater than 575 mg of THC per day.;
20. The method of any one of claims 17 to 19, wherein the recommended variety of cannabis is selected from the group consisting of Cognitiva MR , Eran Almog MR , Luminarium MR , Midnight MR , Nollia MR and Sedamen MR and dosage of cannabis is a low daily dose, a medium daily dose or a high daily dose listed in Table 12.;
21 . The method of any one of claims 1 to 16, wherein the recommended variety of cannabis is for cannabis that contains a therapeutically effective amount of CBD and the method comprises determining the presence of absence of genetic variants associated with CBD metabolism, optionally variants in CYP2C19 and/or CYP3A4.;
22. The method of claim 21 , wherein the recommended dosage of cannabis is a low daily dose, a medium daily dose, a high daily dose or an extra high daily dose.;
23. The method of claim 21 or 22 wherein the recommended dosage of cannabis is for inhalation, such as by smoking or vaping, and the low daily dose is less than 195 mg of CBD per day, the medium daily dose is between 195 and 325 mg of CBD per day, and the high daily dose is greater than 325 mg of THC per day and less than 400 mg of CBD per day, and the extra high daily dose is greater than 400 mg of CBD per day.;
24. The method of any one of claims 21 to 23, wherein the recommended variety of cannabis is Avidekel™ and dosage of cannabis is a low daily dose, a medium daily dose, a high daily dose or an extra high daily dose listed in Table 13.;
claim 21: 25. The method of any one of claims 1 to 24, wherein the sample is a cheek swab.;
claim 22: 26. The method of any one of claims 1 to 24, wherein the sample is a blood sample. 27. The method of any one of claims 1 to 26, wherein determining the presence or absence of the one or more genetic variants comprises testing the sample for the presence or absence of the one or more genetic variants.;
claim 23: 28. The method of claim 27, wherein testing the sample comprises polymerase chain reaction (PCR), optionally multiplex PCR, nucleic acid sequencing, primer extension and/or use of a microarray.;
claim 24: 29. A method of treating a subject with a medical condition comprising: determining a recommended dosage and variety of cannabis for treating the subject with the medical condition according to any one of claims 1 to 28; and administering the recommended dosage and variety of cannabis to the subject.;
claim 25: 30. The method of claim 29, wherein the administering the recommended dosage and variety of cannabis to the subject comprises self-administration.;
claim 26: 31 . A method for treating pain in a subject in need thereof, the method comprising: detecting the presence or absence of one or more SNP variants listed in Table 15 in a sample from the subject; selecting a subject for treatment with CBD based on the presence or absence of the one or more SNP variants; and administering CBD to the subject selected for treatment with CBD.;
claim 27: 32. The method of claim 31 , comprising administering cannabis comprising CBD to the subject, optionally Avidekel.;
claim 28: 33. The method of claim 31 or 32, wherein administering CBD comprises self-administration. 34. The method of any one of claims 31 to 33, wherein the subject is selected for treatment based on the presence of an A allele at SNP rs734969, optionally a heterozygous A allele at SNP rs734969.;
claim 29: 35. Use of CBD for the treatment of pain in a subject in need thereof, wherein the subject has been selected for treatment based on the presence or absence of one or more SNP variants listed in Table 15.;
claim 30: 36. The use of claim 34, wherein cannabis comprising CBD is used for the treatment of pain in the subject, optionally Avidekel.;
claim 31: 37. The use of claim 35 or 36, wherein the subject is selected for treatment based on the presence of an A allele at SNP rs734969, optionally a heterozygous A allele at SNP rs734969.;
claim 32: 38. A method for treating pain in a subject in need thereof, the method comprising: detecting the presence of one or more SNP variants listed in Table 16 in a sample from the subject; selecting a subject for treatment with THC based on the presence or absence of the one or more SNP variants; and administering THC to the subject selected for treatment with THC.;
claim 33: 39. The method of claim 38, comprising administering cannabis comprising THC, optionally Sedamen or Luminarium.;
claim 34: 40. The method of claim 38 or 39, wherein administering THC comprises self-administration.;
claim 35: 41 . The method of any one of claims 38 to 40, wherein the subject is selected for treatment based on the presence of a T allele at SNP rs1856908, optionally a heterozygous T allele at SNP rs1856908.;
claim 36: 42. Use of THC for the treatment of pain in a subject in need thereof, wherein the subject has been selected for treatment based on the presence or absence of one or more SNP variants listed in Table 16. 43. The use of claim 42, wherein cannabis comprising THC is used for the treatment of pain in the subject, optionally Sedamen or Luminarium.;
claim 37: 44. The use of claim 42 or 43, wherein the subject is selected for treatment based on the presence of a T allele at SNP rs1856908, optionally a heterozygous T allele at SNP rs1856908.

Summary

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