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."
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Notes to Editors
GW Pharmaceuticals is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. Full details of GW and the company's clinical trials programme can be found at www.gwpharm.com. See Notes to Editors in the News & Media section.
GW Pharmaceuticals plc is quoted on the London Stock Exchange's AIM market. The Company was set up in December 1997 after discussions with UK government officials. GW operates under licences issued by the UK Home Office to cultivate, possess and supply cannabis for medical research purposes.
Clinical research programme: GW's clinical research programme is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. GW's team is also supported by a number of prominent scientific advisers in this field in Europe and North America.
GW has developed sub-lingual sprays that enable the material to be absorbed directly into the blood stream via the mucosa under the tongue, rather than swallowed. The sprays contain formulations of pharmaceutical grade extracts of specific varieties of the cannabis plant. These varieties are selected for their content of two principal cannabinoids, THC and CBD.
In GW's trials, test medicines comprise cannabis-based medicinal extracts consisting of different cannabinoid ratios and placebo. The trials are "double blind", that is, neither patient nor doctor know which material is being tested on each occasion. Specific aspects of the patients' condition are studied to demonstrate the effects of the drug and to establish a dose/response relationship.
In the UK, having established an acceptable dose range and having shown therapeutic benefit in Phase Two, large-scale studies are now being undertaken in Phase Three. Hundreds of patients may be entered into each study, which compare active formulations with a placebo in a random order. Studies have been underway since 1999 into Multiple Sclerosis, Rheumatoid Arthritis and other forms of nerve pain.
Cultivation programme: GW benefits from more than 10 years research expertise on cultivation and analysis of the cannabis sativa plant; the GW laboratory is undertaking a ground-breaking programme of formulation work for clinical delivery. The strategy of GW is to ensure quality and consistency at the starting material stage by using defined clones from specific varieties of the plant, and by implementing strict control of the growing conditions. GW's plants are grown in a highly secure glasshouse facility. All aspects of the growing climate - temperature, humidity, air changes and photoperiod - are controlled by computer. Strict Standard Operating Procedures are observed to ensure non-contamination by chemicals, infestation or fungal growth, consistency of content, methods of harvest, drying, primary extraction, storage, and onward consignment.
Dr Geoffrey W Guy, Chairman of GW Pharmaceuticals, is a pharmaceutical physician with some 20 years experience in pharmaceutical development covering New Chemical Entities, Biotechnology products, plant based medicines and drug delivery systems. Dr Guy has been the physician in charge of over 250 clinical studies including first dose in man, pharmacokinetics, pharmacodynamics, dose ranging, controlled clinical trials, and large scale multi-centered studies and clinical surveys. Specialist areas of interest include Narcotic Analgesics, Hormone Replacement Therapy, Asthma and Eczema. Dr Guy was the founder of Ethical Holdings plc, the pharmaceutical drug delivery group, and of Phytopharm plc, a phytomedicines company.
GW Pharmaceuticals plc (14/08/01) 020 7601 1000
Geoffrey Guy, Executive Chairman (Thereafter) 01980 619 000
Justin Gover, Managing Director
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