Use of cannabidiol in the treatment of tuberous sclerosis complex

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 is5 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 10 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.

1 . Cannabidiol (CBD) for use in the treatment of tumours associated with Tuberous Sclerosis Complex (TSC). 
     
     
         2 . CBD for use according to  claim 1 , wherein the tumours associated with TSC are benign tumours. 
     
     
         3 . CBD for use according to any of the preceding claims, wherein the size of the tumours associated with TSC are reduced. 
     
     
         4 . CBD for use according to any of the preceding claims, wherein the CBD is provided at a dose suitable to inhibit the formation of the tumours associated with TSC. 
     
     
         5 . CBD for use according to  claim 1 , wherein the CBD is used in combination with one or more concomitant drugs used in the treatment of TSC. 
     
     
         6 . CBD for use according to  claim 2 , wherein the one or more concomitant drugs used in the treatment of TSC is an mTOR inhibitor. 
     
     
         7 . CBD for use according to  claim 3 , wherein the mTOR inhibitor is rapamycin or everolimus. 
     
     
         8 . CBD for use according to any of the preceding claims, wherein the CBD is present as a highly purified extract of cannabis which comprises at least 95% (w/w) CBD. 
     
     
         9 . CBD for use according to  claim 5 , wherein the extract comprises less than 0.15% THC. 
     
     
         10 . CBD for use according to  claim 5  or  6 , wherein the extract further comprises up to 1% CBDV. 
     
     
         11 . CBD for use according to  claim 1 , wherein the CBD is present as a synthetic compound. 
     
     
         12 . CBD for use according to any of the preceding claims, wherein the dose of the one or more concomitant drugs used in the treatment of TSC that are used in combination with the CBD is reduced. 
     
     
         13 . CBD for use according to any of the preceding claims, wherein the dose of CBD is greater than 5 mg/kg/day. 
     
     
         14 . A method of treating a patient with Tuberous Sclerosis Complex (TSC) comprising administering cannabidiol (CBD) in a therapeutically effective amount to prevent or reduce tumours associated with TSC to the patient in need thereof.