Release of Positive Data from Completed Phase II Pain Trial

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Sep 30, 2002

GW Pharmaceuticals plc, the pharmaceutical company developing a portfolio of non-smoked cannabis-based prescription medicines, announces the latest Phase II data from a completed 34 patient study in patients with Multiple Sclerosis (“MS”), Spinal Cord Injury and other conditions, suffering primarily from severe pain. This new data represents the largest patient study presented to date by GW and demonstrates significant benefits for patients, notably in the relief of pain and improvement in sleep.

The data was presented by Dr Willy Notcutt, James Paget Hospital, Great Yarmouth, at the American Academy of Pain Management in Reno, Nevada, USA on Saturday 28 September 2002.

In his pain clinic, Dr Notcutt examined 34 patients with severe symptoms resulting from MS, Spinal Cord Injury and other medical conditions which could not be treated satisfactorily with current medications. The placebo-controlled trial included three different cannabis-based medicines. Of the 34 patients, 28 obtained benefit or significant benefit and elected to continue on to a long-term trial. Twenty-five are still on that trial, a number of which have been taking the medication for over 2 years. Only six of the patients obtained no benefit from the medication.

Dr Geoffrey Guy, Executive Chairman of GW, commented, “We are delighted with the results of this study in patients with severe pain. The data shows improvements with all three of our cannabis-based medicines and we therefore believe that there will be a market for all three medicines in pain treatment in due course.

“Separately, I am also pleased to report that patient recruitment and data analysis for a number of our Phase III trials has proceeded ahead of schedule. We now expect to announce preliminary Phase III results in November.”

Commenting on his Phase II trial data, Dr Notcutt said, “Patients in this trial are suffering from severe pain - it dominates their lives. Given the previously intractable nature of their pain symptoms, the improvements provided by cannabis-based medicines are all the more remarkable. Many of those with chronic pain also suffer from a poor quality of sleep, which – over time – can have profoundly negative effects on them and their families. By bringing about improvements in their sleep regime, as well their pain, we can have a major positive impact on their quality of life.”

The Phase II trial employed a ‘within patient randomised double-blind placebo-controlled crossover’ design. All patients received three different cannabis-based medicines characterised by different content of cannabinoids, the active molecules unique to the cannabis plant, and placebo. The medicines investigated were a THC-rich product, a CBD-rich product and an equal ratio THC:CBD product. During the trial, patients remained on all their current medication, hence any changes against placebo may be considered to be improvements over and above that which could be achieved with their current medication.

In the 34 patients, statistically highly significant lower mean overall symptom scores were observed with the THC:CBD product, THC product and CBD product compared to placebo. The positive CBD result is of particular interest as CBD is a non-psychoactive component of cannabis that was generally thought to have primarily anti-inflammatory rather than analgesic qualities. This corroborates the evidence for CBD analgesic activity from a pilot study in Oxford, which was reported by Dr Philip Robson, Medical Director of GW, at a meeting of the International Cannabinoid Research Society in California in July.

A separate analysis of only the 16 patients with MS also confirmed a statistically highly significant reduction in symptom scores using the THC:CBD product and THC product.

Highly significant improvements in both sleep quality and sleep duration were also observed with both the THC:CBD and THC products compared with placebo.

All the products were very well tolerated. The adverse event profile across all GW’s Phase II trials, including patients from this study, shows a significantly lower incidence of side effects for the THC:CBD product compared with the THC product.

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