GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced it has commenced a Phase 2/3 clinical trial of Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
"The results of our open-label trial of Epidiolex in children with Dravet syndrome have been very encouraging and we are excited to begin this important placebo-controlled clinical trial," stated Orrin Devinsky MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Principal Investigator of the trial.
"As one of the largest epilepsy centers in the country, our focus has always been to find new and innovative ways to treat and cure children with various forms of epilepsy," said Dr. Angus Wilfong, neurologist at Texas Children's Hospital. "Initial trials of Epidiolex have shown promising signals of efficacy in children with treatment-resistant epilepsy, and we are pleased to have the opportunity to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophic form of epilepsy," he continued.
"We are pleased to have advanced Epidiolex into the pivotal stage of clinical development. The start of this Phase 2/3 trial represents a significant milestone for children that suffer with Dravet syndrome for which there remains a substantial unmet medical need," stated Justin Gover, GW's Chief Executive Officer. "Epidiolex is the first plant-based CBD medicine to be studied in a FDA-authorized, placebo-controlled trial and we look forward to working with leading pediatric epilepsy centers across the U.S. to advance this clinical program as rapidly as possible."
The Phase 2/3 trial is a two-part randomized double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy trial of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are being treated with other anti-epileptic drugs. Part one comprises the pharmacokinetic and dose-finding elements of the trial in a total of 30 patients over a three week treatment period. Part two is a placebo-controlled safety and efficacy evaluation of Epidiolex over a three month treatment period in a total of 80 patients. All patients who complete the study will be eligible to receive Epidiolex under a long term open label extension study.
GW anticipates commencing an additional Phase 3 trial in Dravet syndrome in the first quarter of 2015 in parallel with part two of the first Phase 2/3 trial. The company also expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the first quarter of 2015.
To obtain information about this clinical trial or eligibility criteria the treating physician should contact: medicaldirector@gwpharm.com