GW Expands Phase Three Clinical Trials Programme

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Apr 11, 2002

GW Pharmaceuticals plc, the company developing a portfolio of non-smoked, cannabis-based prescription medicines, announces the commencement of Phase Three clinical trials in four new indications.

These latest four Phase Three trials will examine the effectiveness of cannabis based medicines in the following medical conditions:

Pain in Spinal Cord Injury

Pain & Sleep in Multiple Sclerosis (MS) and Spinal Cord Injury

Neuropathic pain in MS

General neuropathic pain (as evidenced by allodynia*)

The trials are double-blind and placebo controlled, and are taking place at a number of centres around the UK. The cannabis-based medicine is being administered by means of a sublingual (under-the-tongue) spray.

GW now has a broad Phase Three trials programme simultaneously examining a range of different symptoms and medical conditions. This programme is designed to generate safety and efficacy data to allow GW to seek regulatory approval for its cannabis-based medicines in a range of medical conditions. Results from the first few trials to complete are intended to form the basis of GW’s first regulatory submission to the Medicines Control Agency, scheduled for 2003.

The four new trials announced today supplement the three Phase Three trials already in progress, all of which continue to recruit well. These trials are:

Multiple Sclerosis (Multiple symptoms)

Cancer pain

Brachial plexus injury (a severe form of nerve-damage pain)

Dr Geoffrey Guy, Executive Chairman of GW Pharmaceuticals, commented, “GW is pursuing a parallel development strategy for its Phase Three trials programme. This strategy incorporates a large number of trials designed to provide the most rapid advancement towards regulatory approval whilst at the same time minimising the risk of delay. To this end, we expect to continue the roll out of Phase Three trials during the course of this year.

“The start of four new Phase Three clinical trials heralds the achievement of another key milestone in our progress towards first regulatory submission for our products. Target timescales for our lead products remain on track and we are aiming to present data for Product Licence Approval in 2003.”

In the event of a Product Licence being granted, the UK Government has indicated that it will be willing to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine. This will allow sufferers of MS, 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.

Enquiries:

GW Pharmaceuticals plc  020 7950 2800
Dr Geoffrey Guy, Executive Chairman  
Justin Gover, Managing Director  
Mark Rogerson, Press and PR  07885 638810

Weber Shandwick Square Mile  020 7950 2800
Kevin Smith/Graham Herring

Notes to Editors

* allodynia is a condition in which stimuli that normally do not hurt cause
pain; for example, clothing brushing lightly across the skin. The form of pain associated with this condition is of neuropathic (nerve-damage) origin.

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 at www.gwpharm.com. See Notes to Editors in the News & Media section.

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