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Gw Pharmaceuticals Initiates Phase 3 Pivotal Study In Tuberous Sclerosis Complex

The following excerpt is from the company's SEC filing.

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that it has commenced a Phase 3 clinical trial of Epidiolex® (cannabidiol or CBD) as an adjunctive therapy for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare genetic disorder, the most common symptom of which is epilepsy. Epilepsy occurs in around 80-90% of TSC patients and is a significant cause of morbidity and mortality. TSC is the third indication that GW is targeting within its Epidiolex clinical development program, which includes four Phase 3 pivotal trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and catastrophic forms of childhood-onset epilepsy. On March 14, 2016, GW announced positive results from the first of these pivotal trials in Dravet syndrome.

“We are pleased to announce the start of this pivotal clinical trial of Epidiolex in TSC, which follows the recent positive results from our trial in patients with Dravet syndrome. Our decision to evaluate Epidiolex in TSC is based on findings from the physician-led Epidiolex expanded access program, which found that TSC patients reported reductions in seizure activity,” stated Justin Gover, GW’s Chief Executive Officer. “With the commencement of this trial, GW’s Epidiolex development program now encompasses three rare epilepsy indications with pivotal trials fully underway. GW is committed to establishing Epidiolex as a new therapy to address the significant unmet need among patients who have few treatment options.”

“In patients with TSC, epilepsy is common, presents early and can become more difficult to treat over time. The results of our open-label study of Epidiolex in children with TSC have been very encouraging and we are excited to begin this important placebo-controlled clinical trial,” stated Elizabeth Thiele, MD, PhD, Director, Pediatric Epilepsy Program at Massachusetts General Hospital, Director, Herscot Center for Tuberous Sclerosis Complex and Professor of Neurology, Harvard Medical School and Principal Investigator of the trial. “As one of the largest TSC treatment centers in the country, our focus has always been on finding new and innovative solutions that improve the lives of people living with TSC.”

At the 69

Annual Meeting of the American Epilepsy Society in December 2015, safety and efficacy data on 10 patients diagnosed with TSC from the physician-led open-label Epidiolex expanded access program were presented by Massachusetts General Hospital for Children (Geffrey

et al 2015

) on Epidiolex treatment of refractory epilepsy in these patients. The percent of patients who reported a 50% or greater...


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