Marijuana-derived drug Epidiolex shows promise; drug could be tested at Georgia Regents University

Company to explore GRU as site for clinical trials

A marijuana-derived drug that might be tested at Georgia Regents University showed success in patients with hard-to-treat seizures, the drug’s maker announced Tuesday.

London-based GW Pharmaceuticals said its Epidiolex cannabidiol drug showed “promising” results in 27 patients with more difficult seizures after at least 12 weeks of treatment. Almost half – 48 percent – had seizures reduced by at least 50 percent; 41 percent had a 70 percent reduction; 22 percent had a 90 percent reduction and 15 percent were seizure-free by the end of the treatment period, the company announced.

All but one of the patients were children, average age 10.5 years, whose seizures are not controlled by current medications. The observations were conducted at New York University’s Langone Medical Center and the University of California at San Francisco.

GW Pharmaceuticals has a Mem­or­andum of Understanding with Georgia Gov. Nathan Deal’s office and GRU to explore opening a clinical trial in Augusta. Company officials are scheduled to visit the campus next month.

In a news release, the company said it had collected safety data on 62 patients, some of whom had not reached 12 weeks of treatment. More than 80 percent experienced at least one adverse event, ranging from sleepiness and fatigue to diarrhea, and either increased and decreased appetite. Most – 80 percent – rated the side effects as mild or moderate, although there were seven serious events, including one death from unexpected epilepsy. The physicians treating those patients did not think the death and serious events were related to the drug, according to the company release.

While there were limitations to how the data was collected, the results were “very positive,” said Dr. Yong Park, who is head of the pediatric epilepsy program at GRU.

In particular was the lack of serious side effects, which often accompany seizure medications, he said. The effects from Epidiolex were “very benign,” Park said.

Hearing that early success was music to the ears of Valerie Weaver, whose 6-year-old son, Preston, has Lennox-Gastaut syndrome and suffers up to 80 seizures a day despite the fact that he is on seven medications.

She has been intrigued with cannabidiol, which is derived from one of marijuana’s active ingredients and does not provide the high of other components, after hearing anecdotal stories of children whose seizures were greatly reduced by it.

“That’s exactly what I was hoping for,” Valerie Weaver said of the early results. “I’m very, very excited.”

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