GRU hosts hearing of evidence for clinical trials of cannabidiol oil use

 

 

A legislative study committee on narrow uses of medical marijuana will hold a hearing Tuesday at Georgia Regents University to hear about potential medical evidence for use, according to the committee co-chairman. GRU itself is on the verge of beginning clinical trials into a purified cannabis oil drug for children with uncontrollable seizures.

The Joint Study Committee on the Prescription of Medical Cannabis will hold its fourth meeting in the ballroom of the Jaguar Student Activities Center on the Summerville campus of GRU. Previous meetings of the committee had heard from families with various medical conditions that might benefit from marijuana-derived oil and concerns from law enforcement about legalization, said Rep. Allen Peake, R-Macon, the chief proponent of legislation that would allow its use only under strict conditions.

The Augusta meeting is a chance to hear from the medical community, and in particular from a pediatric neurologist in Colorado who has been treating children with cannabidiol oil and has “some very interesting findings,” he said.

Cannabidiol is one of the main active ingredients in cannabis and anecdotes about some of the remarkable progress in children with severe seizure disorders have prompted some Georgia families to move to Colorado, where they can legally receive it. Peake’s bill is focusing on products that are high in cannabidiol and very low in tetrahydrocannabinol or THC, the psychoactive ingredient in marijuana that produces a high.

GW Pharmaceuticals of London has already created a drug out of highly purified cannabidiol. The company has an agreement with GRU and the state of Georgia to begin clinical trials at GRU in children with severe seizure disorders.

There have been two Investigational New Drug Applications filed with the Food and Drug Administration for clinical trials, the first a two-person expanded access trial of the drug, called Epidiolex. That trial has been approved by the FDA and GRU’s Institutional Review Board and is hopefully in the “final stages” of approval by the Drug Enforcement Administration, said Dr. Michael Diamond, interim Senior Vice President for Research at GRU. That trial could commence as soon as this month if GRU gets the DEA approval soon, he said.

“We’re looking for it at any time,” Diamond said. Because marijuana and its products are considered Schedule 1 controlled substances, GRU principal investigator Yong Park would need a Class 1 license from the DEA to receive the cannabidiol products, he said.

The second, larger trial would be a multi-center trial in Augusta, Savannah and Atlanta and GRU has asked initially to include 50 patients, although a smaller number might be approved. Diamond said he believes GRU has the go-ahead from FDA on that trial but has yet to see it in writing. There have already been discussions about whether that trial might ultimately need to be expanded, he said.

“My expectation is that we will have greater demand than the 50 individuals,” Diamond said.

While much of the early work has focused on children with severe seizures, there has also been some “anecdotal evidence” that cannabidiol could have a positive impact for those with muscle spasticity, such as patients with multiple sclerosis, Peake said. When the legislation is written, it will probably be focused on a limited number of diagnoses but he could envision a medical advisory panel that could weigh evidence cannabidiol is effective for other conditions.

“We’re interested in seeing what other opportunities are out there for this to provide some therapeutic benefit for citizens,” Peake said. “If there is an opportunity to help other citizens, we’re all for it.”

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Mon, 10/23/2017 - 18:35

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