GW Expands Phase Three Clinical Trials Programme of Cannabis-Based Medicine Into Cancer Pain

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Jan 16, 2002

GW Pharmaceuticals plc, the company developing a portfolio of non-smoked cannabis-based prescription medicines, announces that it has expanded its Phase Three clinical trials programme into cancer pain. This Phase Three trial is the first large-scale trial of its kind and will examine the effectiveness of a cannabis-based medicine in treating pain associated with cancer.

Cancer pain represents the second key target market for GW’s programme of developing cannabis-based medicines for a range of medical conditions. The Institute of Medicine in the United States has reported that some of the most encouraging clinical data on the effects of cannabis on chronic pain are from studies of cancer pain.

Over 100 patients, who have terminal cancer and are experiencing pain that is not responding adequately to current therapy, will take part in the double-blind, placebo-controlled study at more than 20 centres around the UK. The cannabis-based medicine is being administered by means of a sublingual (under-the-tongue) spray.

Dr Geoffrey Guy, Executive Chairman of GW, commented, “This is a significant milestone for GW, and - we hope - for sufferers from cancer pain. Cannabis-based medicine has the potential to provide considerable advantages over current medications to cancer patients. The potential market is very significant since approximately 40 per cent of cancer sufferers at present have unmet needs in pain suppression.”

The new cancer trial is part of a significant expansion of GW’s pivotal regulatory clinical trials programme which will continue throughout the coming months. GW is already conducting a Phase Three trial in Multiple Sclerosis patients. Recruitment for this trial is proceeding on track with 135 patients screened, of which 62 are already enrolled. Up to a further 35 patients may become eligible for entry in the coming weeks.

As part of its clinical trials expansion, GW has commenced further clinical studies including a Phase Three randomised placebo-controlled trial in brachial plexus injury, a severe form of nerve-damage pain. (This injury commonly results from motorcycle accidents and follows a wrenching of the arm and traumatic disruption of nerve connections leading to extreme pain.)

The aim of each of GW’s clinical programmes is to prepare data for Product Licence Approval by the Medicines Control Agency. Phase Three of the trials programme is the final stage in preparing for an application to be made for a Product Licence Approval.

New positive data from GW’s Phase Two clinical trials in Multiple Sclerosis and Spinal Cord Injury is provided in the preliminary results announced separately today. This encouraging data shows significant improvements in a range of symptoms.

1 Institute of Medicine, Division of Neuroscience and Behavioral Health, Janet E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., “Marijuana and Medicine: Assessing the Science Base”

- Ends -


GW Pharmaceuticals plc  
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Dr Geoffrey Guy, Executive Chairman  
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Notes to Editors

There are approximately 26 million people throughout the world suffering from cancer at any one time. It has been reported that approx 40 per cent of cancer sufferers have unmet needs in pain suppression, of which approx 55 per cent are suffering from neurogenic pain.

The brachial plexus is a network of nerves that conducts signals from the spine to the shoulder, arm, and hand. Brachial plexus injuries are caused by damage to those nerves. Symptoms may include a limp or paralysed arm, lack of muscle control in the arm, hand, or wrist, and lack of feeling or sensation in the arm or hand.

GW Pharmaceuticals plc is traded on the London Stock Exchange’s AIM market (ticker GWP). GW operates under licences issued by the UK Home Office to cultivate, possess and supply cannabis for medical research purposes. The company has over 90 staff and maintains close control over all aspects of the research and development process - cultivation, pharmaceutical development, production, clinical trials and regulatory affairs. Full details of GW and the company’s clinical trials programme can be found See Notes to Editors in the News & Media section.

Cannabis-based medicines: GW’s products are derived from standardised whole extracts of proprietary cannabis plant varieties bred to exhibit a pre-determined content of cannabinoids. Cannabinoids are molecules unique to the cannabis plant. The focus of GW’s research to date has been on two cannabinoids – Tetrahydrocannabinol (THC) and Cannabidiol (CBD). A number of products incorporating extracts from THC plants, CBD plants and blended ratios of THC and CBD extracts, are in late stage development and are targeted at conditions for which cannabis is commonly understood to be beneficial and for which there is a strong scientific foundation for the application of cannabinoids.

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 these studies, which compare active formulations in a double-blind randomised placebo-controlled manner. Studies have been underway since early 2000 into Multiple Sclerosis, Rheumatoid Arthritis and other forms of nerve pain.

In August 2001, GW announced that it had commenced Phase Two 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.

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.

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