Cannabis oil clinical trial at Georgia Regents University might not be only option

Running a clinical trial of cannabis-derived oil for 50 children with uncontrollable seizures could cost the state of Georgia $7-8 million, an official with Georgia Regents University told a legislative study committee meeting in Augusta on Wednesday.

 

But outside of that limited number, entities in the state might be authorized to grow and produce the oil for the thousands of others who might benefit from it, the chief proponent for the legislation said.

The Joint Study Committee on the Prescription of Medical Cannabis for Serious Medical Conditions met at GRU to hear about progress in getting clinical trials started on a drug from GW Pharmaceuticals called Epidiolex that is a highly purified form of cannabidiol, one of the main active compounds in marijuana, with only minuscule amounts of the psychoactive compound tetrahydrocannabinol. An expanded access study for two patients is only awaiting final approval from the Drug Enforcement Administration and that could come any day, said Dr. Michael Diamond, Interim Senior Vice President for Research at GRU.

The 50-patient study, which would also include Children’s Healthcare of Atlanta and an institution in Savannah, has been verbally approved by the Food and Drug Administration but is still awaiting approval by GRU’s Institutional Review Board and another review by the DEA. More than $500,000 has probably been spent getting to this point and supporting a clinical for 50 children for a year could be as much as $8 million, Diamond said. That money might come to GRU but would go out to support the families and those running the clinical trial across the state, he said.

“It would flow through us but it would not all be spent in Augusta,” Diamond said. The reason the cost is so high is the state of Georgia is sponsoring the study and bearing all the infrastructure costs normally borne by a pharmaceutical company or other sponsor, he said.

Cannabis oil is being used to treat scores of children with uncontrolled seizures in states where medical marijuana is legal but Georgia would be one of the first to get it into clinical trials, said Jason Cranford, founder of the Flowering Hope Foundation in Colorado, which grows and produces high-content cannabidiol oils to treat around 200 children.

“You guys are ahead of the game,” he said.

Cranford had approached universities in his state but they feared putting at risk federal funding because the federal government still considers it illegal even if the state doesn’t. GRU should be protected by the permissions granted by DEA, such as a Class 1 license for the principal investigator, Diamond said. But he is concerned about the parents, who will be given the drug to administer at home to the child in the trial and wondered what GRU might be able to give them such as a letter or something to protect them.

“I don’t know that there is any magic letter that is going to help them,” Augusta Judicial Circuit District Attorney Ashley Wright said at the meeting. It would hopefully be handled like any other prescription drug in that they might have to show they have a prescription for it and are possessing it legally, she said.

If the 50 slots fill up quickly, GRU is prepared to ask for another 50 and maybe even more beyond that, Diamond said, But that would still leave thousands who might need the oil without access, said Rep. Allen Peake, R-Macon, co-chair of the committee and one of the chief proponents of the legislation.

“We believe there should be dual paths,” he said. “We fully support the clinical trial process with GW Pharma. And we hope it is successful and we hope it works in kids.”

But with thousands of others with uncontrollable seizures, and patients with other conditions who might benefit, “Why not set up that safe and effective timely delivery system so that all of our citizens can benefit?” Peake said, adding that means a homegrown solution.

“It’s clear that to come up with an effective system in Georgia you have to grow it, manufacture it and process it,” he said. “It’s got to be safe, it’s got to be effective and it’s got to be timely. That’s our full intent is to come up with legislation that addresses that with the solution here in Georgia.”

Once approved, and all of the licensing sorted out, it shouldn’t take more than four months to grow a crop and get an effective oil produced, said Cranford, who has been producing high cannabidiol strains for five years and can produce strains that consistently deliver the same amount each time, making it easy to standardize a dose. Right now, he is helping to treat almost a dozen Georgia kids whose families fled to Colorado so the children could legally obtain the oil. And it is those families that Peake is also trying to help.

“We need to get these families home,” he said.

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