Porton Down, UK, 30 September 2010: GW Pharmaceuticals plc (GWP:AIM) announces that it has commenced the first of a programme of Phase IIa exploratory clinical trials exploring GW’s cannabinoids as potential treatments in the field of type 2 diabetes and metabolic syndrome. This study programme follows promising pre-clinical research results and comprises at least three small scale clinical trials evaluating various metabolic parameters.
The first Phase IIa study to commence is a multi-centre, randomised, double blind, placebo controlled, parallel group pilot study in the treatment of dyslipidaemia in patients with Type 2 diabetes. A total of 50 patients will be divided into five treatment groups comprising four different cannabinoid formulations and placebo. Following a 2-5 week baseline period, the treatment duration will be 13 weeks.
At least two additional studies are planned as part of this programme. One of these further studies is due to start later this year and another is due to start in 2011. The overall programme is aimed at examining the effects of GW cannabinoids on a range of features of the metabolic syndrome including cholesterol, lipid parameters, glucose control and insulin sensitivity.
This progress into Phase IIa clinical trials follows a significant pre-clinical research programme on GW cannabinoids in several models of type 2 diabetes at the GW Metabolic Research Laboratory. This Laboratory is led by Professor Mike Cawthorne, Director of Metabolic Research at the Clore Laboratory, University of Buckingham, and a recognized world leading authority in the research of new treatments for metabolic syndrome.
Results of this research have shown desirable effects of a number of GW cannabinoids on plasma insulin, leptin and adiponectin levels, hormones of particular relevance to the development and treatment of diabetes and metabolic function. In addition, these results have shown a reduction in total cholesterol with an increase in the proportion of HDL (good) cholesterol.
Dr Stephen Wright, R&D Director, said, “This Phase II study is the first of a series of pilot Phase II studies that GW aims to perform over the next 12-18 months to evaluate GW’s new cannabinoid product candidates in the field of diabetes and metabolic syndrome. Following promising results from pre-clinical studies, we believe that this research programme offers the potential for significant new pipeline opportunities.”
The development potential and therapeutic value of the various candidate cannabinoids will be assessed at the outcome of this trials programme. GW anticipates providing a further announcement about the likelihood of progression of candidates into further Phase II trials following review of the findings of this initial programme.
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Notes to Editors
GW Metabolic Research Laboratory
In 2009, GW entered into an exclusive strategic alliance with Professor Mike Cawthorne and the Clore Laboratory, University of Buckingham, focusing on the research of cannabinoids, and other phytomedicines, in the field of type 2 diabetes and metabolic disease. As part of this alliance, a dedicated section of the Clore Laboratory was named the “GW Metabolic Research Laboratory”.
Professor Cawthorne is Director of Metabolic Research at the Clore Laboratory, University of Buckingham and a recognized world leading authority in the research of new treatments for obesity and type 2 diabetes. At SmithKline Beecham he was Group Director for diabetes and obesity research and led the research team that discovered rosiglitazone (Avandia®).
The principal objectives of this strategic alliance are as follows:
to provide GW with a dedicated facility for undertaking pre-clinical pharmacologic studies of cannabinoids in the area of metabolic disease
to provide GW with exclusive access to plant-based therapies under evaluation at the Clore Laboratory
to support the pharmaceutical development of new GW cannabinoid medicines to address defined aspects of the metabolic syndrome
to provide expert advice to GW, through Professor Cawthorne, in the metabolic disease area
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’s products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals.