GWP.L Regulatory News (GWP)

4 Jun 2007 07:00

GW Pharmaceuticals PLC04 June 2007 GW Commences Phase I Study of THCV, a Potential Treatment for Obesity and Related Metabolic Disorders Porton Down, UK, 4 June 2007: GW Pharmaceuticals (AIM: GWP) announces that ithas commenced the clinical development programme of its novel cannabinoidproduct, delta-9-tetrahydrocannabivarin (THCV). THCV has shown promise inpre-clinical studies as a potential treatment for obesity, diabetes and relatedmetabolic disorders. The Phase I study, in which dosing has commenced, is a randomised, double blind,placebo controlled, dose escalation, safety and tolerability study of singledoses of THCV in twelve healthy volunteer subjects. The formulation is anextract from a unique cannabis plant variety bred by GW scientists whichexhibits THCV as the principal cannabinoid component. The product is beingadministered as an oral solution. GW's pharmacology research team, led by Professor Roger Pertwee at theUniversity of Aberdeen, has shown THCV to be an antagonist at CB1 and CB2receptors (1). In pre-clinical studies, THCV has shown effects on body weight,body fat content, energy expenditure, food intake, and other obesity-relatedparameters. The human endocannabinoid system is known to play an important rolein the regulation of body weight and metabolic homeostasis. To date, the moststudied CB1 receptor antagonist is Rimonabant, a new product developed bySanofi-Aventis. The primary objective of the Phase I study is to evaluate the safety andtolerability of single doses of formulated THCV compared with placebo. ThisPhase I clinical study is being carried out at a single centre in the UK and hasbeen designed in accordance with EU guidance notes for the clinical developmentof new medicinal products in obesity. Dr Stephen Wright, R&D Director, said, "Today marks the first human dosing of anovel cannabinoid candidate in a key target therapeutic area and is an importantmilestone for GW as we expand our cannabinoid product pipeline. The pre-clinicalevidence for THCV is compelling as a potential treatment for obesity and relatedmetabolic disorders, and we are excited to be advancing this product intoclinical trials. Indeed, this is the first of a range of cannabinoids which formpart of a programme of work addressing the metabolic syndrome. If this Phase Itrial is successful, we shall seek to progress the programme by embarking onstudies in obese subjects." 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 (1) Thomas A, Stevenson LA, Wease KN, Price Mr, Baillie G, Ross RA, Pertwee RG. Evidence that the Plant Cannabinoid Delta-9-Tetrahydrocannabivarin is a Cannabinoid CB1 and CB2 Receptor Antagonist, Br J Pharmacol. 2005 Dec; 146 (7): 917-26. 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 information is provided by RNS The company news service from the London Stock Exchange