GWP.L Regulatory News (GWP)

22 Jan 2008 07:01

GW Pharmaceuticals PLC22 January 2008 Highly Promising Results for New GW Cannabinoid Treatments for Diabetes and Related Metabolic Disorders Preparations underway for commencement of Phase II trials in 2008 Porton Down, UK, 22 January 2008: GW Pharmaceuticals plc (AIM: GWP) announcesthat it has generated highly promising results in both pre-clinical pharmacologystudies and a Phase I trial of a new potential cannabinoid treatment for type 2diabetes and related metabolic disorders. This research is part of a programmebeing conducted by GW to evaluate selected cannabinoids in a range oftherapeutic areas. GW's initial cannabinoid target in this field, delta-9-tetrahydrocannabivarin(THCV), has successfully completed extensive pre-clinical pharmacology studiesand its first Phase I clinical trial. The pre-clinical studies have yielded highly promising findings. Recent resultsin several models of diabetes show desirable effects on plasma insulin, leptinand adiponectin levels, hormones of particular relevance to the development andtreatment of diabetes, especially in obese individuals. In addition, we haveseen 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, placebocontrolled, dose escalation, safety and tolerability study of single doses ofTHCV in twelve healthy volunteer subjects. This trial showed that the studymedication was well tolerated at target therapeutic doses and demonstrated asatisfactory safety profile. Following on from this first study, GW is now preparing for a Phase IIa multipledose 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-relatedparameters. Dr Stephen Wright, R&D Director of GW, said, "These new results confirm thatGW's proprietary plant-based cannabinoids have significant potential astreatments in this important branch of therapeutics. We are now ready to buildupon the pre-clinical data, as well as the Phase I trial results, by enteringPhase II proof of principle studies during 2008." Dr Geoffrey Guy, Chairman, said, "This exciting research programme is a furtherexample of the range of potential for GW's cannabinoids as new medicines. Webelieve that our research in the field of metabolic disorders represents asignificant opportunity for GW and that it has the potential to be an importantnew area for future collaboration with partners." Enquiries: GW Pharmaceuticals plc Today: +44 20 7831 3113Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000Justin Gover, Managing Director Financial Dynamics Tel: +44 20 7831 3113David Yates, Ben Atwell Notes to Editors About Metabolic Syndrome The Metabolic Syndrome describes a cluster of symptoms and signs which typicallyoccur together. These are Type 2 diabetes, dyslipidemia (particularly raisedcholesterol and reduced HDL-cholesterol), fatty liver, central obesity andhypertension. Underlying the syndrome are abnormalities of some of thefundamental mechanisms of normal energy metabolism, notably increased insulinresistance. The consequences of the metabolic syndrome include an increasedmorbidity and mortality from inflammatory and cardiovascular disease (heartdisease and stroke) in particular. The incidence of the metabolic syndrome isrising in parallel with the increase in central obesity, and its effectivetreatment represents a major challenge to society. About GW GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products for patientswho suffer from a range of serious ailments, in particular pain and otherneurological symptoms. GW has assembled a team of over 100 scientists withextensive experience in developing both plant-based prescription pharmaceuticalproducts and medicines containing controlled substances. GW occupies a worldleading position in cannabinoids and has developed an extensive internationalnetwork of the most prominent scientists in the field. This news release may contain forward-looking statements that reflect theGroup's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Group's products. Forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including (inter alia), the success of the Group's research strategies, theapplicability of the discoveries made therein, the successful and timelycompletion of clinical studies, including with respect to Sativex and theGroup's other products, the uncertainties related to the regulatory process, andthe acceptance of Sativex and other products by consumers and medicalprofessionals. This information is provided by RNS The company news service from the London Stock Exchange