US victory for cannabis-based cancer drug
January 04, 2006
Charlotte Moore, The Guardian (UK)
A drug derived from cannabis to treat severe pain in cancer patients has been given the go-ahead to enter final stage trials in the US. GW Pharma, which is licensed to grow certain varieties of cannabis, said the US food and drug administration had given it the green light to carry out phase III trials of its drug, Sativex. A spokesman for the company said: "This is a major step. The US is the world's largest pharmaceutical market."
The trial will establish whether the drug relieves pain in patients suffering from an advanced form of cancer who do not experience relief from opioid drugs such as morphine. About 250 patients will be enrolled in the trial.
Sativex contains two chemicals - tetrahydrocannabinol and cannabidiol - which the company extracts from plants it grows in secret locations. The drug is approved in Canada to relieve pain in patients suffering from multiple sclerosis. In the UK, the company is still conducting trials to gain approval for treating muscle tightness in multiple sclerosis patients.
GW said it had raised $15m (£8.6m) by selling new shares to New York-based Polygon Investment Partners. Its executive chairman, Dr Geoffrey Guy, said: "This financing will permit GW to start the US development of Sativex while the company seeks a US licensing partner."