Gov. Nathan Deal, Georgia Regents University and GW Pharmaceuticals signed a memorandum of understanding potentially including GRU in the company’s clinical trials of a cannabidiol oil drug called Epidiolex and creating a whole new trial, said Dr. Michael Diamond, vice president of clinical and translational services at GRU.
“This is the first step to agreeing that we want to work together on this,” he said.
GW Pharmaceuticals earlier this month announced it had received approval from the Food and Drug Administration to pursue more clinical trials in Epidiolex in children with Dravet syndrome, a childhood seizure disorder. The first trial would be 30 patients and the second part a placebo-controlled trial with 80 patients, with all study subjects able to get the drug at the end of the trial. GRU is hoping its pediatric epilepsy program can participate in that trial, Diamond said.
The company also has plans to open up clinical trials for a second devastating childhood seizure disorder known as Lennox-Gastaut, which it hopes to begin next year. Just hearing the first steps are being taken was great news to Valerie Weaver, whose six-year-old son, Preston, has Lennox-Gastaut and suffers up to 80 seizures a day despite taking seven medications.
“I’m completely excited about it,” she said.
The university and state also plan to work with the company on a new protocol for a clinical trial for children with difficult-to-treat seizures who do not have those two syndromes, which would have to be submitted to FDA for approval, Diamond said. There is even a possibility for other collaborations with GW Pharmaceuticals, which is scheduled to visit GRU in July, he said.
The agreement signed Tuesday does not prohibit GRU from pursuing other avenues for cannabidiol oil clinical trials, Diamond said.
The National Institute on Drug Abuse research farm at the University of Mississippi planted its first marijuana crop this spring that would be specifically rich in cannabidiol, Diamond said. That would potentially be another source, but it would have to be refined and purified and GW Pharmaceuticals is much further along with its drug, which would make it the more expeditious route, Diamond said.
Weaver’s interest in the oil has been stoked by anecdotal stories of children like her son who were incapacitated by seizures but made remarkable recoveries after they were given the oil.
“I think this is going to change modern medicine as we know it in this area,” she said. “I have a really, really good feeling about it, just based on the homework I’ve done.”