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Data Show Promising Signals of Efficacy and Safety Conference Call Today at 8:30 a.m. ET, 1:30 p.m. (UK)
LONDON, June 17, 2014 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced physician reports of efficacy and safety data on 27 children and young adults with treatment-resistant epilepsy who have been treated with GW's investigational cannabidiol (CBD) product candidate, Epidiolex®, for a period of 12 weeks. The treatment-resistant patients suffer from a range of epilepsies in which current anti-epileptic drugs have been unsuccessful in adequately controlling seizures, and included such severe forms of epilepsy as Dravet syndrome and Lennox-Gastaut syndrome. Uncontrolled data from two hospital sites in the United States that were generated under expanded access Investigational New Drug applications (INDs) authorized by the Food and Drug Administration (FDA) were made available to the Company.
"We are pleased to report preliminary data on Epidiolex which provides promising signals of efficacy in children with treatment-resistant epilepsy, including patients with Dravet syndrome. It is noteworthy that, of the patients who have responded to Epidiolex, a high proportion show a reduction in seizure frequency of greater than 50% and a portion of these patients were reported to be seizure-free at the end of 12 weeks of treatment," stated Justin Gover, GW's Chief Executive Officer. "We believe that these signals of efficacy, together with the side effect profile observed to date, support GW's decision to advance Epidiolex into a formal development program and we look forward to commencing a Phase 2/3 clinical trial of Epidiolex in Dravet syndrome in the second half of 2014."
"There remains an enormous unmet need in a range of pediatric and adult treatment-resistant epilepsy syndromes, which affect approximately 750,000 Americans. Some of the greatest needs are in children with severe epilepsy syndromes such as Dravet and Lennox-Gastaut, where frequent seizures often persist despite high doses of multiple anti-epileptic drugs," stated Orrin Devinsky MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Director, NYU Comprehensive Epilepsy Center. "The initial open-label study with Epidiolex has provided encouraging results. Some children have had marked reductions in their seizures and overall, the medication has been well tolerated."