27 May 2014 – The state, GW Pharmaceuticals (NASDAQ: GWPH), and Georgia Regents University Augusta (GRU), announced today that they have entered into a Memorandum of Understanding to study GW’s investigational cannabidiol (CBD) product Epidiolex® in the treatment of children with medication-resistant 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 for difficult-to-treat forms of childhood epilepsies. Deal’s commitment to this research has led to this plan to form collaboration between GRU and GW Pharmaceuticals. It is expected that details of the collaboration will be finalized in the coming months in order for research to commence later this year.
“I have learned the stories of brave Georgia families desperately seeking treatment for their children’s debilitating condition,” Deal said. “As governor, it is my responsibility to address the needs of and protect our state’s most vulnerable citizens, especially when they are suffering. I’m grateful to Georgia Regents University and GW Pharmaceuticals for their leadership on this venture, and I’m confident that this public-partnership will deliver relief and improve quality of life for these children and their 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 U.S. Food & Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA). The FDA has already authorized, physician-sponsored Investigational New Drug (IND) programs with Epidiolex at 12 sites around the U.S involving over 300 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 (LGS).
“We are pleased that the State of Georgia has selected GW as their partner in this research program and we look forward to working together to commence this important research. Georgia Regents University has the experience, expertise, and infrastructure to implement this research in accordance with the highest scientific and regulatory standards,” stated Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals. “This collaboration is a great opportunity for stakeholders in Georgia to access true scientific data that should inform and expand their understanding of how CBD works in such a challenging and vulnerable patient population.”
“As the state’s public academic medical center, our primary missions are patient care, education, and research,” said GRU President Dr. Ricardo Azziz. “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.”