GW Starts Canadian Medicinal Cannabis Trials
LONDON (Reuters) - GW Pharmaceuticals Plc, a British company developing the world's first cannabis-based medicines for pain relief, said on Tuesday it was starting clinical trials in Canada.
The Phase II trial -- the only one of its kind in North America -- will take place under the supervision of Dr. Daniel DeForge of the Rehabilitation Centre, Ottawa Hospital. It will include suffers of multiple sclerosis, spinal cord injury and other forms of chronic pain.
GW Pharma, which floated in London in June, already has an advanced trials program in Britain where its cannabis-based medicine entered final Phase III tests on patients in May.
The Salisbury-based firm is developing prescription drugs to harness the medicinal benefits of cannabis and has created a product which will be delivered using an under-the-tongue spray.
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GW Pharmaceuticals plc ("GW or "the Company")
GW PHARMACEUTICALS STARTS MEDICINAL CANNABIS TRIALS IN CANADA
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
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
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
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."
- Ends -
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 (http://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
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
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.