Patent application title: Novel reference plant, a method for its production, extracts obtained therefrom and their use
Inventors: Etienne De Meijer
Agents: WOLF GREENFIELD & SACKS, P.C.
Assignees: GW Pharma Limited
Origin: BOSTON, MA US
IPC8 Class: AA61K36185FI
USPC Class: 424725
Abstract:
The invention relates to a reference plant which has been selected to: a) not express a medicinally active compound or group of compounds; yet b) express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant. The reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity.
Claims:
1. A reference plant which has been selected to:a) not express a medicinally active compound or group of compounds; yetb) express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plantsuch that the reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity.
2. A reference plant as claimed in claim 1 which is a cannabis plant and the active compound or group of compounds are the cannabinoids.
3. A reference plant as claimed in claim 2 which contains a monogenic mutation that blocks the cannabinoid biosynthesis in Cannabis sativa.
4. A reference plant as claimed in claim 2 wherein the reference plant comprises a cannabinoid knock out factor governing a reaction in the pathways towards the phenolic moieties olivetolic and divarinic acid.
5. A reference plant as claimed in claim 1 characterised in that a homogenised bulk extract exhibits a profile of entourage compounds which is quantitatively substantially similar to that of a reference plant.
6. A reference plant as claimed in claim 5 wherein the homogenised bulk extract has a % v/w oil yield of greater than 0.14%, more preferably greater than 0.2%, through 0.3% to 0.4% or more.
7. A reference plant as claimed in claim 1 characterised in that a homogenised bulk steam distilled extract comprises both monoterpenes and sesquiterpine.
8. A reference plant as claimed in claim 7 wherein the monoterpenes comprise at least myrcene, alpha pinene and beta pinene.
9. A reference plant as claimed in claim 8 wherein the myrcene, alpha pinene and beta pinene comprise at least 50%, through 60% to at least 70% of the monoterpenes detected.
10. A reference plant as claimed in claim 8 further comprising limonine and optionally linalol.
11. A reference plant as claimed in claim 10 further comprising cis- and/or trans-verbenol.
12. A reference plant as claimed in claim 7 wherein the sesquiterpenes comprise at least carophyllene and humulene.
13. A reference plant as claimed in claim 12 further comprising carophyllene oxide.
14. A reference plant as claimed in claim 12 in which humelene epoxide II is not detected.
15. A reference plant as claimed in claim 2, substantially comprising stalked glandular trichomes.
16. A reference plant as claimed in claim 15 wherein the density of the stalked glandular trichomes is comparable to a cannabinoid producing plant.
17. A reference plant as claimed in claim 15 comprising small, grey, dull trichomes of various shapes (FIG. 2a).
18. A reference plant as claimed in claim 17 in which some trichomes comprise headless; pinhead and/or shrivelled trichomes which may be flat, convex or concave.
19. A reference plant as claimed in claim 15 in which the trichomes are free of white trichome heads.
20. A reference plant as claimed in claim 1 characterized in that it expresses monoterpenes, diterpenes, carotenoids, phytol and tetraterpenes.
21. A reference plant as claimed in claim 1 characterized in that it expresses sesquiterpenes, sterols and triterpenes.
22. A reference plant as claimed in claim 20 which expresses entourage compounds selected from one or more of:monoterpenes; sesquiterpenes; and flavonoids.
23. A reference plant as claimed in claim 1 having branching characteristic of a drug producing phenotype as opposed to a fibre producing phenotype.
24. A reference plant as claimed in claim 1 exhibiting vigour, characterized in that the total above ground dry weight is substantially equivalent to that of comparator drug producing plants.
25. A method of producing a reference plant which does not express a medicinally active compound or group of compounds yet express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant comprising:a) Selecting a plant which does not express a medicinally active compound or group of compounds;b) Selecting a therapeutically active comparator plant; andc) Crossing the plant which does not express a medicinally active compound or group of compounds with the therapeutically active comparator plant to obtain an F1 progeny and self crossing the F1 progeny to obtain an F2 progeny which is selected for the characteristics sought.
26. A method as claimed in claim 25 further comprising successive back crosses with a comparator plant to selectively breed for the desired characteristics.
27. An extract obtainable from a reference plant as claimed in claim 1.
28. A placebo comprising an extract as claimed in claim 27.
29. A method of testing a hypothesis that one or more compounds present in a plant extract are responsible or are solely responsible for the extracts pharmacological activity comprising:i) selecting a plant as claimed in claim 1;ii) obtaining an extract therefrom; andiii) running comparative tests against the extract obtained from a comparator plant.
30. A method of producing a designer plant extract comprising the steps of:i) selecting a plant extract as claimed in claim 27; andii) combining the extract of (i) with one or more medicinally active components.
Inventors: Etienne De Meijer
Agents: WOLF GREENFIELD & SACKS, P.C.
Assignees: GW Pharma Limited
Origin: BOSTON, MA US
IPC8 Class: AA61K36185FI
USPC Class: 424725
Abstract:
The invention relates to a reference plant which has been selected to: a) not express a medicinally active compound or group of compounds; yet b) express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant. The reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity.
Claims:
1. A reference plant which has been selected to:a) not express a medicinally active compound or group of compounds; yetb) express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plantsuch that the reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity.
2. A reference plant as claimed in claim 1 which is a cannabis plant and the active compound or group of compounds are the cannabinoids.
3. A reference plant as claimed in claim 2 which contains a monogenic mutation that blocks the cannabinoid biosynthesis in Cannabis sativa.
4. A reference plant as claimed in claim 2 wherein the reference plant comprises a cannabinoid knock out factor governing a reaction in the pathways towards the phenolic moieties olivetolic and divarinic acid.
5. A reference plant as claimed in claim 1 characterised in that a homogenised bulk extract exhibits a profile of entourage compounds which is quantitatively substantially similar to that of a reference plant.
6. A reference plant as claimed in claim 5 wherein the homogenised bulk extract has a % v/w oil yield of greater than 0.14%, more preferably greater than 0.2%, through 0.3% to 0.4% or more.
7. A reference plant as claimed in claim 1 characterised in that a homogenised bulk steam distilled extract comprises both monoterpenes and sesquiterpine.
8. A reference plant as claimed in claim 7 wherein the monoterpenes comprise at least myrcene, alpha pinene and beta pinene.
9. A reference plant as claimed in claim 8 wherein the myrcene, alpha pinene and beta pinene comprise at least 50%, through 60% to at least 70% of the monoterpenes detected.
10. A reference plant as claimed in claim 8 further comprising limonine and optionally linalol.
11. A reference plant as claimed in claim 10 further comprising cis- and/or trans-verbenol.
12. A reference plant as claimed in claim 7 wherein the sesquiterpenes comprise at least carophyllene and humulene.
13. A reference plant as claimed in claim 12 further comprising carophyllene oxide.
14. A reference plant as claimed in claim 12 in which humelene epoxide II is not detected.
15. A reference plant as claimed in claim 2, substantially comprising stalked glandular trichomes.
16. A reference plant as claimed in claim 15 wherein the density of the stalked glandular trichomes is comparable to a cannabinoid producing plant.
17. A reference plant as claimed in claim 15 comprising small, grey, dull trichomes of various shapes (FIG. 2a).
18. A reference plant as claimed in claim 17 in which some trichomes comprise headless; pinhead and/or shrivelled trichomes which may be flat, convex or concave.
19. A reference plant as claimed in claim 15 in which the trichomes are free of white trichome heads.
20. A reference plant as claimed in claim 1 characterized in that it expresses monoterpenes, diterpenes, carotenoids, phytol and tetraterpenes.
21. A reference plant as claimed in claim 1 characterized in that it expresses sesquiterpenes, sterols and triterpenes.
22. A reference plant as claimed in claim 20 which expresses entourage compounds selected from one or more of:monoterpenes; sesquiterpenes; and flavonoids.
23. A reference plant as claimed in claim 1 having branching characteristic of a drug producing phenotype as opposed to a fibre producing phenotype.
24. A reference plant as claimed in claim 1 exhibiting vigour, characterized in that the total above ground dry weight is substantially equivalent to that of comparator drug producing plants.
25. A method of producing a reference plant which does not express a medicinally active compound or group of compounds yet express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant comprising:a) Selecting a plant which does not express a medicinally active compound or group of compounds;b) Selecting a therapeutically active comparator plant; andc) Crossing the plant which does not express a medicinally active compound or group of compounds with the therapeutically active comparator plant to obtain an F1 progeny and self crossing the F1 progeny to obtain an F2 progeny which is selected for the characteristics sought.
26. A method as claimed in claim 25 further comprising successive back crosses with a comparator plant to selectively breed for the desired characteristics.
27. An extract obtainable from a reference plant as claimed in claim 1.
28. A placebo comprising an extract as claimed in claim 27.
29. A method of testing a hypothesis that one or more compounds present in a plant extract are responsible or are solely responsible for the extracts pharmacological activity comprising:i) selecting a plant as claimed in claim 1;ii) obtaining an extract therefrom; andiii) running comparative tests against the extract obtained from a comparator plant.
30. A method of producing a designer plant extract comprising the steps of:i) selecting a plant extract as claimed in claim 27; andii) combining the extract of (i) with one or more medicinally active components.