Friday, August 2, 2019

CBD Oil Trial Extended

UMC issued the following press release written by Annie Oeth:


Results from a clinical trial of a new marijuana-derived drug to treat seizures in children prompted approval of a one-year extension to the study.

The clinically tested investigational drug product is an oral cannabidiol, CBD for short, derived from marijuana grown at the University of Mississippi School of Pharmacy’s National Center for Natural Products Research. To conduct the trial, required approvals were obtained in 2018 from the Drug Enforcement Agency and the Food and Drug Administration.

The trial, conducted by the University of Mississippi Medical Center and the UM School of Pharmacy, was approved for 10 patients. All patients in the initial trial opted to participate in the extension.

Treatment with the drug, described as “compassionate care for the sickest of the sick” by principal investigator Dr. Brad Ingram was proven to be safe in the trial’s first six months.

“We found no significant safety issues,” said Ingram, UMMC associate professor of pediatric neurology and director of the UMMC Pediatric Comprehensive Epilepsy Program. “We will be changing a few things in the way the trial is conducted. In the first six months of this trial, we were looking at tolerability. Now the trial’s focus will shift to how well patients are responding and whether we are still seeing a positive response in 12 months.”

Those in the trial “are patients whose lives have been devastated by their epilepsy, even up to their abilities to walk, talk, or participate in simple activities of self-care,” Ingram said.

The extract, a Schedule I controlled substance, is prepared from a special type of marijuana that has a high concentration of CBD and a low concentration of THC, the psychotropic element of marijuana.

Results so far have shown promise, Ingram said. “Some of the trial participants are at the status quo, and some have had a really good response to the drug. All of the participants, though, seem to have some positive outcome, such as more pleasant mood or sleeping better.

“Even with patients whose seizure counts are unchanged, parents said their children are happier,” Ingram said. “We had a teenage patient say ‘mom’ to their mother for the first time ever. We had patients whose parents were able to take them to the grocery store for the first time.”

Dr. Richard Summers, UMMC associate vice chancellor for research, said the extension reflects on the initial trial’s results.

“The FDA extension is a next great step forward toward developing this natural product into a therapeutic with the promise of controlling seizures in many patients that have failed conventional treatment,” Summers said. “The allowance of an extension is also a reflection of the great success of our initial trial and the quality of the research operations of the UMMC CBD team. We are hoping to use these efforts as a springboard for other future potential areas of use for this compound.”

Dr. Larry Walker, director emeritus of the NCNPR, hopes the trial extension will lead to the drug becoming available in the future.

Walker was instrumental in planning the study and in arranging to provide the study materials to UMMC through the National Institute on Drug Abuse’s drug supply program, for which NCNPR is the sole supplier of marijuana and cannabis extract.

“We are very happy that the CBD extract trial has been extended for another year,” Walker said. “We’ve been pleased to see how the patients and their families have benefited from the study, and are hopeful that another year will provide a basis to begin a development program of a federally approved cannabis-based botanical drug.”

In the trial, extracts of a marijuana strain grown on the University of Mississippi Oxford campus are being manufactured, packaged and checked to ensure all quality control specifications are met before being transferred to the pharmacy at UMMC’s main campus in Jackson. There, the extract is diluted with pharmaceutical-grade sesame oil to achieve the proper dosage concentration.

Walker said the partnership between NCNPR and UMMC opens the door to progress. “Dr. Mahmoud A. ElSohly’s team at the NCNPR has worked diligently on the product development, manufacturing, regulatory clearances and other hurdles. This promises to be a milestone that could greatly stimulate the national research agenda for developing FDA-approved cannabis-derived drug products.”

The possibility of organizing this clinical trial came about in 2014, when the Mississippi Legislature passed a law allowing the Medical Center to dispense CBD oil for the treatment of epileptic seizures in children.

Sen. Josh Harkins, R-Flowood, who authored the bill, said he’s pleased that the trial has been extended. “Patient safety is the most important thing, and through this study, researchers are taking the proactive, correct approach. Their progress is backed with scientific data and is being made in the most responsible manner. We hope that this will bring help to more patients in the future.”

####

19 comments:

Anonymous said...

Dominos, a major sponsor of weed, is thrilled.

Said it’s ceo - “cool dude.”

It’s a joke people....we all know this is not weed....

But like winter....weed is coming

Anonymous said...

A little known fact: Ole Miss has been growing marijuana for the DEA since at least the early 80s. The pot is rolled into cigarettes and dispensed to select patients across the U.S.

I can't remember his name, but a former Ole Miss alumnus and NFL player used to run the program.

Anonymous said...

More ground breaking advancement in Mississippi.....meanwhile you can buy CBD oil online or in any vape store without a prescription.

But I do hope it helps these patients.

Anonymous said...

if you don't snore or haven't used MJ then you are in the minority and are a 60 year white, middle class tea toter worried more about how you look than what you think or say! Get real. Wake up Mississippi.

Anonymous said...

Meanwhile in Starkville .... hahahahaha. Not much research being done there.

Anonymous said...

@10:31. Just building and hosting super computers. So-yeah, not much.

https://research.noaa.gov/article/ArtMID/587/ArticleID/2467/Mississippi-State-University-to-host-supercomputer-to-power-NOAA-research

Anonymous said...

I heard Bomgar will be passing out roach clips at the polls.

Anonymous said...

Serious question: What medical benefits does THC offer that CBD doesn't?

THC gets you high, CBD doesn't. So all the medical marijuana drones, why do we need the chemical that turns people into mindless dolts if all the medical benefits are available in something that doesn't impact the mind?

Anonymous said...

@12:07 I don't know what it is but he sure as hell makes folks less crazy than alcohol.

Anonymous said...

This is good, but CBD is only part of the equation, and this trial only helps a pitifully small number of people. CBD and THC are just two of the thousands of compounds in a marijuana plant. "Whole plant medicine" is currently helping sick people in over 30 states. It's past time for Mississippi to offer medical marijuana this to people here.

Anonymous said...

CBD works

Anonymous said...

@12:07 Because cannabinoids can be more enjoyable to some when all are present.

You people do know that Israel prescribes medical cannabis to its older population that suffers from PTSD after going through the holocaust, right? Some might say it’s kosher.

Anonymous said...

My mother has Parkinson's. At her last visit, her doctor had a poster for CBD oil in the exam room. I asked about it. He said he has only seen the benefit in one patient, which was a seizure patient.

It seems everyone knows someone who knows someone else that has heard of someone benefiting, but there are few first hand accounts of seeing improvement.

Anonymous said...

Jim Urbanek is the former Ole Miss football player who ran the program. I met him at a frat party in 1972. He told me his job at the Marijuana Farm was to keep out the drunk frat boys on the weekend.

Anonymous said...

12:07, you’re assuming the treatment has a high enough THC to make you high. The marijuana that gets you high normally has 20 to 40% THC. What they are using in this trial likely doesn’t approach that amount. For example, industrial hemp, which is classified as marijuana, typically contains less than 0.5% THC. You appear to be basing your opposition on assumptions.

But by all means, complain about epileptic children getting relief because you are uncomfortable with pot. After all, you have a First Amendment right to be an asshole for no reason.

Anonymous said...

What difference does it make if 'it works'? Half or more of the prescriptions we get from our docs are useless, other than the psychological benefit of being able to say 'he gave me a prescription'.

Two months ago I saw a surgeon as a followup regarding continuing pain at the site of the incision. He prescribed one of those dose-packs...the same thing most docs prescribe for poison ivy. Take six today, five tomorrow, four the next day and so on. Useless for my issue. But, he was able to record in my file that he had seen me and written a prescription. So, insurance pays him.

Last week he prescribed what I later found out is the same thing as Aspercreme but at a much higher cost. I called his nurse to report that my insurance won't pay for it and she said, just go to Wal Mart and get OTC Aspercreme...it's the same thing. But, we can always say we got a prescription.

Anonymous said...

@10:31 Uh, Dude - MS State leads the state in research dollars friend.....in the last two years? #1 in Research & Development

https://www.msstate.edu/newsroom/article/2018/12/msu-remains-highest-ranked-research-university-mississippi-according-latest/

https://www.msstate.edu/newsroom/article/2017/12/nsf-survey-msu-remains-highest-ranked-research-university-state/

Anonymous said...

Lol. So funny how butt-hurt the marijuana worshipers get whenever they're challenged. It's a religion to them.

"bro weed isn't addictive i just spend a third of my paycheck on it and i'm depressed without it and i smoke it every single day because it calms me bro"

Anonymous said...

10 people in the trial? Is this some kinda joke?

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