Published on December 30, 2014
AUGUSTA, Ga. – Two clinical trials aimed at treating children with medication-resistant epilepsy with cannabidiol have been approved at Augusta University. The first – a two-person compassionate use protocol that received authorization from both the Drug Enforcement Administration and the U.S. Food and Drug Administration – begins today at Children’s Hospital of Georgia. The second will allow for an expanded 50-person trial, initiated at Augusta University with planned expansion to Savannah and Atlanta.
The state, along with GW Pharmaceuticals (NASDAQ: GWPH), and officials at Augusta University have been working together since May to begin a study with GW’s investigational cannabidiol (CBD) product Epidiolex®, which has promising data for difficult to treat childhood epilepsies.
Georgia Governor Nathan Deal announced in April his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis plant, and develop rigorous data that will inform and expand the scientific community’s understanding of potential treatments.
“No one with a heart could hear the stories of these children and their parents and not want to exhaust every possibility to provide them with the treatment they need to combat this debilitating condition,” said Gov. Nathan Deal. “I believe this initiative can have a meaningful and positive impact on the health of suffering children. Georgians have expressed overwhelming support for these endeavors, and I’m committed to finding solutions for these brave families.”
GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the FDA and DEA. The FDA has already authorized physician-sponsored Investigational New Drug programs with Epidiolex at 20 sites around the U.S involving over 400 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.
“We are pleased to be partnering with the State of Georgia and Augusta University in response to the significant unmet needs of children with treatment-resistant epilepsies by providing physicians with access to our medicine Epidiolex,” said Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals. “In parallel with this Augusta University program, GW is advancing a formal clinical trial program with the FDA and has commenced placebo-controlled clinical trials designed to gain approval for Epidiolex as a prescription medicine.”
“As the state’s public academic medical center, we should be on the leading edge in the treatment of these disorders,” said Augusta University President Dr. Ricardo Azziz. “Georgia’s children should not have to go elsewhere. We have a responsibility to bring the medicine of tomorrow to patient care today. We are excited to partner with GW Pharmaceuticals to study investigational cannabidiol and potentially change the lives of children with medication-resistant epilepsies.”
Families of children with difficult to treat seizure disorders who are interested in enrolling in the Epidiolex trial at Augusta University can contact lead investigator Dr. Yong Park at (706) 721-3371.
About GW Pharmaceuticals:
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 2/3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
About Augusta University and Health System:
Augusta University is one of four public comprehensive research universities in the state with nearly 10,000 students enrolled in its nine colleges and schools, which include the Medical College of Georgia – the nation’s 13th-oldest medical school – the nationally-ranked Hull College of Business and Georgia’s only Dental College of Georgia. The clinical enterprise associated with the university includes the 478-bed Georgia Regents Medical Center and the 154-bed Children’s Hospital of Georgia. Augusta University is a unit of the University System of Georgia and an equal opportunity institution. http://www.augusta.edu
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