Over four years after Gov. Phil Bryant signed Harper Grace’s Law, allowing clinical trials of a specific marijuana-derived drug, the University of Mississippi Medical Center announced Thursday that those trials had begun.
The trial, which will study the effect of cannabidiol—or CBD, as it’s known—on children with severe epilepsy, is the very first university-based clinical trial of a cannabis extract to meet federal standards. The agencies that had to sign off on the trial before it could start include the Food and Drug Administration, the Internal Review Board and the Drug Enforcement Administration.
“So you can imagine we’ve had many regulatory hurdles to get here today … in order to provide such unique opportunities for our patients,” said Richard Summers, UMMC’s vice chancellor of research.
The trial will enroll ten Mississippi children with severe epilepsy, though the university estimates that epilepsy is common enough that about 2,000 Mississippi children could qualify. More than a third of children with epilepsy still seize, even with medications on the current market, and this study will target those particular children, according to Dr. Brad Ingram, a pediatric neurologist and the principal investigator for this project.
“(We are) targeting the sickest of the sick… the early parts of this research are targeted at making sure this is tolerable by children who have failed all other medical therapies,” Ingram said.
So far nine children are enrolled in the trial. The last patient has been identified and will be enrolled next week, which is when the first two patients will come back for their follow-up appointments, Ingram said.
“It is far too early for us to detail any kind of results at this point but thus far—we’re one month in on two patients and almost one month in on seven additional ones—and things are thus far going very very well. We’re very very excited about it. A real opportunity for Mississippi kids to get access to a really unique controlled product,” Ingram said.
Although 33 states have legalized marijuana for medical use, the issue is still controversial because, federally, marijuana is a controlled substance. Sen. Josh Harkins, who sponsored Harper Grace’s Law in 2014, said he sat down with a number of Mississippi agencies and groups, from the Southern Baptist Convention to the Mississippi Bureau of Narcotics, and received their blessing before pushing the bill.
“So it was important we get out there in front of this and I wanted to make sure that what we did was going to be something that would stand up to the test of scrutiny. I wanted to make sure that we were going to do this in the right way, that people weren’t going to just be able to pop up their own little shop and grow their own crop and try to dispense it to the public as a safe viable option for seizure medication,” Harkins said at the news conference Thursday.
To that end, Harper Grace’s Law opened the door to a very specific partnership between researchers at the University of Mississippi Medical Center and the National Center for National Products Research, which is based at the University of Mississippi in Oxford. The Center is focused on the discovery and development of new pharmaceutical and agrochemical technologies based on plants, animals and microbes. One of those plants, of course, is marijuana.
“I thought, ‘Wow, we’ve got this great institution that has the only farm in the country where they grow (marijuana) and study it … We’ve got a medical school that does great research,” Harkins said. “So why not marry these two up and do something?”
But once legalized in Mississippi, UMMC’s research proposal still had to get the blessing of several federal agencies, a process that delayed the start of the study.
“This really is first in the country I think for a state program to be able to do something like this,” said Larry Walker, chair emeritus at the Natural Products Center.
“We hope this is going to open the door to further well-controlled clinical studies that will answer the question, ‘is this good for different (conditions)?'”