On Monday, UK-based GW Pharmaceuticals announced the start of clinical trials of Sativex as a treatment for aggressive brain cancer.
Sativex is an oral spray made from ingredients derived from the whole cannabis plant. The two main compounds in cannabis – CBD and THC – are present in Sativex in an equal 1:1 ratio.
Both cannabis compounds (known as cannabinoids) have shown anti-cancer properties in pre-clinical studies, and seem to be effective against a wide range of cancers. Anecdotal reports also suggest that cannabis and cannabinoids have the ability to fight cancer.
However, GW Pharmaceuticals is the first company to initiate clinical research on cannabis-based medicine as a cancer therapy.
While GW has previously funded a number of pre-clinical studies on the anti-cancer effects of cannabinoids, this will be the first time the company investigates the effects in human patients, said GW Director of Research and Development Dr. Stephen Wright in a press release.
“We are very excited about moving this compound into further human study and the prospects of cannabinoids as new anti-cancer treatments. This is GW’s first clinical study of cannabinoids as a potential treatment to inhibit tumor growth.”
The company plans to investigate Sativex as an add-on to the standard chemotherapy agent temozolomide, rather than a stand-alone. According to GW Pharmaceuticals, pre-clinical research suggests that cannabinoids can improve the anti-cancer ability of temozolomide.
The Phase 1b/2a trial announced on Monday will involve 20 patients with recurrent glioblastoma multiforme (GBM), an aggressive and rare form of brain cancer that accounts for about 50% of all brain cancers diagnosed in the U.S. each year.
The trial will first have to prove the safety of the combined treatment regimen before further research can be done on its effectiveness.
In the U.S., clinical trials of cannabinoids for cancer are also expected in the near future. Sean McAllister, Ph.D and his colleagues at California Pacific Medical Center hope to begin the first human studies of CBD for breast cancer within the next 12 months.
Sativex is currently approved in more than 20 countries for the treatment of multiple sclerosis symptoms, and is also being studied as a treatment for cancer pain.
While Sativex has been GW’s leading product, the company has a number of other cannabinoid-based drugs in its pipeline, including an epilepsy drug called Epidiolex.
Epidiolex, which contains more than 98 percent CBD, recently began clinical trials in the U.S. and UK as a treatment for pediatric epilepsy.