GW Pharmaceuticals, the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines, has obtained encouraging results from the latest phase of its clinical trials, and is now extending its programme into Phase Three trials, involving a wider range of patients in a number of new locations. The company has also obtained regulatory approval to commence clinical trials in Canada.
Phase Three of the UK trials programme will be the largest such study undertaken to date by GW and will involve hundreds of patients. This Phase will initially be co-ordinated from Oxford and will be extended to three other centres at Reading, Northampton and Amersham.
The aim of GW's clinical development programme is to prepare data for Product Licence Approval by the Medicines Control Agency. Phase Three of the trials programme is the final pivotal stage in preparing for an application to be made for a Product Licence Approval. In the event of a Licence being granted, the UK Government has confirmed to the House of Lords Science & Technology Select Committee that it would be willing to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine.
GW has so far committed £12 million of investment to its research programme, and hopes to bring to market its first prescription medicine as early as 2003. This product and others which will follow thereafter will allow sufferers of Multiple Sclerosis, Cancer Pain, Rheumatoid Arthritis, Spinal Cord Injury and other neurological disorders to experience the medical benefits of cannabis without unwanted psychoactive side effects, and without the health dangers associated with smoking.
Results to date appear to show significant reduction in pain, muscle spasm and bladder dysfunction as well as improved neurological function. In addition, patients are able to self-titrate (adjust) their dose so as to provide the suitable level of medical benefit without incurring unwelcome side effects.
Patients in the trials programme are taking different formulations of cannabis-based medicines by means of a sub-lingual spray device - it is sprayed under the tongue and absorbed, rather than swallowed. The patients also take an inactive 'placebo'. Neither the researchers nor the patients know whether they are using the active substance or the placebo at any given time.
Dr Geoffrey Guy, Chairman of GW Pharmaceuticals, said, "Data from our four Phase Two studies in approximately seventy subjects is positive and encouraging. Patients are clearly gaining benefit. These results provide enough confidence for us to increase the number of trial centres and the number of patients taking part. We are seeing a significant improvement in quality of life for sufferers of a range of medical conditions and look forward to extending the trials programme."
"In addition, we are pleased to have received approval for an IND (Investigational New Drug) from Health Canada, allowing us to commence the company's first Phase Two trial in Canada. This marks the first step in the international roll-out of GW's product activity."