GW Pharmaceuticals Starts Medicinal Cannabis Trials in Canada 14 August 2001

GW Pharmaceuticals plc, the company developing a portfolio of prescription medicines derived from cannabis, is commencing clinical trials in Canada. This is the first trial undertaken outside the United Kingdom by GW, and is believed to be the only trial of its kind in North America.

The start of this first trial in Canada follows the grant to GW earlier this year of an Investigational New Drug (IND) by Health Canada, the Canadian regulatory authority. The Phase Two trial, in which patients will take cannabis-extract by means of a sub-lingual (under-the-tongue) spray, will include sufferers of Multiple Sclerosis, Spinal Cord Injury and other forms of chronic pain, and will be under the supervision of Dr Daniel DeForge, of The Rehabilitation Centre, Ottawa Hospital. The trial will be randomised and double-blind - that is, neither doctors nor patients will know whether drug or inactive placebo is being taken.

In addition to providing useful data on GW's non-smoked cannabis-based medicines, the Canadian trial will provide GW with a platform from which to expand further research in Canada.

The commencement of trials in North America follows the rapid progress of GW's European programme. Following a series of Phase Two trials involving 75 patients that have been underway in the UK since May 2000, GW started its first Phase Three clinical trial in Multiple Sclerosis in the UK in May 2001. Recruitment for this trial is now well underway.

Dr Geoffrey Guy, GW's Executive Chairman, will be providing a progress report on the company's UK Phase Two trials in a keynote speech at the American Academy of Pain Management in early September. GW has previously noted that patients in these trials are clearly gaining benefit with clinically significant improvements in a range of symptoms, including pain, muscle spasms, spasticity, bladder related symptoms, tremor and overall improvements in quality of life.

Canada allows sufferers from chronic conditions such as Multiple Sclerosis and Arthritis to apply to possess and to cultivate cannabis for medical purposes legally. The Canadian Medical Association and other organisations have expressed concern over this development in that smoked cannabis does not offer physicians and patients a solution which fits the norms of medical practice. GW's programme is designed to provide an appropriate long term solution for Canadian patients by providing a non-smoked prescription medicine which harnesses the medical benefits of cannabis and which is of proven quality, safety and efficacy and approved as a prescription medicine by Health Canada.

Dr Geoffrey Guy, Chairman of GW Pharmaceuticals said, "The start of clinical trials in Canada is the first phase of our international trials programme. The Canadian health authorities have recognised the potential contribution of cannabis-based medicines in the treatment of many different conditions. GW has been in discussion with Health Canada for some time and has developed a close and positive working relationship over that period. We remain committed to the view that a non-smoked form of cannabis-medicine developed in full accordance with the standards of modern pharmaceuticals offers the best solution for patients."

--And coming soon to a drugstore near you GW Pharma's Savitex; launched in Europe last July.