Granted Patent
B2
US 12,263,139 · App. 18/161,603 · Granted Apr 1, 2025
Use of cannabidiol in the treatment of tuberous sclerosis complex
Inventors:
Benjamin Whalley (Cambridge, GB); William Hind (Cambridge, GB); Royston Gray (Cambridge, GB); Michael Bazelot (Cambridge, GB); Ines De Silva Serra (Reading, GB); Claire Williams (Reading, GB); Andrew Tee (Cambridge, GB)
Assignee:
JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
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Abstract
The present invention relates to the use of cannabidiol (CBD) for the treatment of tumours associated with Tuberous Sclerosis Complex (TSC). In particular the CBD was able to decrease the number and size of marker cells, pS6, in a zebrafish model of TSC. This is suggestive of a disease modifying effect whereby treatment with CBD could result in the reduction or prevention of the benign tumours that occur in TSC patients. Preferably the CBD used is in the form of a highly purified extract of cannabis such that the CBD is present at greater than 98% of the total extract (w/w) and the other components of the extract are characterised. In particular the cannabinoid tetrahydrocannabinol (THC) has been substantially removed, to a level of not more than 0.15% (w/w) and the propyl analogue of CBD, cannabidivarin, (CBDV) is present in amounts of up to 1%. Alternatively, the CBD may be a synthetically produced CBD. In use the CBD is given concomitantly with one or more other drugs used in the treatment of TSC. Such drugs may include rapamycin and/or everolimus.
Claims (26)
1. A method of reducing mTOR activity in a population of Tsc2−/− cells, comprising:
administering from 5 μM to 20 μM cannabidiol (CBD) to the population of Tsc2−/− cells in vitro;
wherein the CBD reduces mTOR activity in the population of Tsc2−/− cells compared to a population of Tsc2−/− cells not administered CBD.
2. The method of claim 1 , wherein administering from 5 μM to 20 μM CBD reduces the number of positive phosphorylated S6 cells in the population of Tsc2−/− cells compared to a population of Tsc2−/− cells not administered CBD.
3. The method of claim 2 , wherein administering from 5 μM to 50 μM CBD further reduces the cell size of pS6 positive cells in a population of Tsc2−/− cells compared to a population of Tsc2−/− cells not administered CBD.
4. The method of claim 1 , wherein the CBD is administered as a highly purified extract of cannabis which comprises at least 95% (w/w) CBD.
5. The method of claim 4 , wherein the CBD extract comprises less than 0.15% (w/w) tetrahydrocannabinol (THC).
6. The method of claim 4 , wherein the CBD extract comprises up to 1% (w/w) cannabidivarin (CBDV).
7. The method of claim 1 , wherein the CBD is present as a synthetic compound.
8. The method of claim 1 , comprising administering CBD in DMSO.
9. The method of claim 8 , wherein the DMSO is present in a composition comprising the population of Tsc2−/− cells at a maximum concentration of 0.05% (v/v).
10. The method of claim 1 , comprising administering 5 μM CBD.
11. The method of claim 1 , comprising administering 10 μM CBD.
12. The method of claim 1 , comprising administering 20 μM CBD.
13. A method of reducing cell migration or invasion in Tsc2−/− cells, comprising:
administering from 5 μM to 20 μM cannabidiol (CBD) to the population of Tsc2−/− cells in vitro;
wherein the CBD reduces cell invasion or migration in the population of Tsc2−/− cells compared to a population of Tsc2−/− cells not administered CBD.
14. The method of claim 13 , wherein the CBD is administered as a highly purified extract of cannabis which comprises at least 95% (w/w) CBD.
15. The method of claim 14 , wherein the CBD extract comprises less than 0.15% (w/w) tetrahydrocannabinol (THC).
16. The method of claim 14 , wherein the CBD extract comprises up to 1% (w/w) cannabidivarin (CBDV).
17. The method of claim 13 , wherein the CBD is present as a synthetic compound.
18. The method of claim 13 , comprising administering CBD in DMSO.
19. The method of claim 18 , wherein the DMSO is present in a composition comprising the population of Tsc2−/− cells at a maximum concentration of 0.05% (v/v).
20. The method of claim 13 , comprising administering 5 μM CBD.
21. The method of claim 13 , comprising administering 10 μM CBD.
22. The method of claim 13 , comprising administering 20 μM CBD.
Assignments (3)
CHANGE OF NAME
Recorded Nov 7, 2024
From: GW RESEARCH LIMITED
To: JAZZ PHARMACEUTICALS RESEARCH UK LIMITED
Reel/Frame 069185/0657 →
SECURITY AGREEMENT
Recorded Jul 26, 2024
From: CAVION, INC.; CELATOR PHARMACEUTICALS, INC.; GW PHARMA LIMITED; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 068173/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 27, 2023
From: WHALLEY, BENJAMIN; HIND, WILLIAM; GRAY, ROYSTON; BAZELOT, MICHAEL; SILVA SERRA, INES DE; WILLIAMS, CLAIRE; TEE, ANDREW
To: GW RESEARCH LIMITED
Reel/Frame 064077/0060 →
Priority Claims (1)
GB 1710042
· Jun 23, 2017
· national
Continuity (2)
Continuation
16624106
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