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Preparations Underway For Commencement of Phase II Trials in 2008

Smokin Moose

Fallen Cannabis Warrior
Porton Down, UK - GW Pharmaceuticals announces that it has generated highly promising results in both pre-clinical pharmacology studies and a Phase I trial of a new potential cannabinoid treatment for type 2 diabetes and related metabolic disorders. This research is part of a programme being conducted by GW to evaluate selected cannabinoids in a range of therapeutic areas.

GW's initial cannabinoid target in this field, delta-9-tetrahydrocannabivarin (THCV), has successfully completed extensive pre-clinical pharmacology studies and its first Phase I clinical trial.

The pre-clinical studies have yielded highly promising findings. Recent results in several models of diabetes show desirable effects on plasma insulin, leptin and adiponectin levels, hormones of particular relevance to the development and treatment of diabetes, especially in obese individuals. In addition, we have seen a reduction in total cholesterol with an increase in the proportion of HDL (good) cholesterol.

The recently completed Phase I trial was a randomised, double blind, placebo controlled, dose escalation, safety and tolerability study of single doses of THCV in twelve healthy volunteer subjects. This trial showed that the study medication was well tolerated at target therapeutic doses and demonstrated a satisfactory safety profile.

Following on from this first study, GW is now preparing for a Phase IIa multiple dose study in type 2 diabetic patients in 2008.

These recent results add to previous findings showing effects on body weight, body fat content, energy expenditure, food intake, and other obesity-related parameters.

Dr Stephen Wright, R&D Director of GW, said, "These new results confirm that GW's proprietary plant-based cannabinoids have significant potential as treatments in this important branch of therapeutics. We are now ready to build upon the pre-clinical data, as well as the Phase I trial results, by entering Phase II proof of principle studies during 2008."

Dr Geoffrey Guy, Chairman, said, "This exciting research programme is a further example of the range of potential for GW's cannabinoids as new medicines. We believe that our research in the field of metabolic disorders represents a significant opportunity for GW and that it has the potential to be an important new area for future collaboration with partners."

Source: GW Pharmaceutical

Notes to Readers

About Metabolic Syndrome
The Metabolic Syndrome describes a cluster of symptoms and signs which typically occur together. These are Type 2 diabetes, dyslipidemia (particularly raised cholesterol and reduced HDL-cholesterol), fatty liver, central obesity and hypertension. Underlying the syndrome are abnormalities of some of the fundamental mechanisms of normal energy metabolism, notably increased insulin resistance. The consequences of the metabolic syndrome include an increased morbidity and mortality from inflammatory and cardiovascular disease (heart disease and stroke) in particular. The incidence of the metabolic syndrome is rising in parallel with the increase in central obesity, and its effective treatment represents a major challenge to society.
 
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