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.”



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.

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'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 the last two years? #1 in Research & Development

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?

Anonymous said...

Thanks for sharing!

Suscribe to latest on JJ.

Recent Comments

Search Jackson Jambalaya

Subscribe to JJ's Youtube channel


Trollfest '09

Trollfest '07 was such a success that Jackson Jambalaya will once again host Trollfest '09. Catch this great event which will leave NE Jackson & Fondren in flames. Othor Cain and his band, The Black Power Structure headline the night while Sonjay Poontang returns for an encore performance. Former Frank Melton bodyguard Marcus Wright makes his premier appearance at Trollfest singing "I'm a Sweet Transvestite" from "The Rocky Horror Picture Show." Kamikaze will sing his new hit, “How I sold out to da Man.” Robbie Bell again performs: “Mamas, don't let your babies grow up to be Bells” and “Any friend of Ed Peters is a friend of mine”. After the show, Ms. Bell will autograph copies of her mug shot photos. In a salute to “Dancing with the Stars”, Ms. Bell and Hinds County District Attorney Robert Smith will dance the Wango Tango.

Wrestling returns, except this time it will be a Battle Royal with Othor Cain, Ben Allen, Kim Wade, Haley Fisackerly, Alan Lange, and “Big Cat” Donna Ladd all in the ring at the same time. The Battle Royal will be in a steel cage, no time limit, no referee, and the losers must leave town. Marshand Crisler will be the honorary referee (as it gives him a title without actually having to do anything).

Meet KIM Waaaaaade at the Entergy Tent. For five pesos, Kim will sell you a chance to win a deed to a crack house on Ridgeway Street stuffed in the Howard Industries pinata. Don't worry if the pinata is beaten to shreds, as Mr. Wade has Jose, Emmanuel, and Carlos, all illegal immigrants, available as replacements for the it. Upon leaving the Entergy tent, fig leaves will be available in case Entergy literally takes everything you have as part of its Trollfest ticket price adjustment charge.

Donna Ladd of The Jackson Free Press will give several classes on learning how to write. Smearing, writing without factchecking, and reporting only one side of a story will be covered. A donation to pay their taxes will be accepted and she will be signing copies of their former federal tax liens. Ms. Ladd will give a dramatic reading of her two award-winning essays (They received The Jackson Free Press "Best Of" awards.) "Why everything is always about me" and "Why I cover murders better than anyone else in Jackson".

In the spirit of helping those who are less fortunate, Trollfest '09 adopts a cause for which a portion of the proceeds and donations will be donated: Keeping Frank Melton in his home. The “Keep Frank Melton From Being Homeless” booth will sell chances for five dollars to pin the tail on the jackass. John Reeves has graciously volunteered to be the jackass for this honorable excursion into saving Frank's ass. What's an ass between two friends after all? If Mr. Reeves is unable to um, perform, Speaker Billy McCoy has also volunteered as when the word “jackass” was mentioned he immediately ran as fast as he could to sign up.

In order to help clean up the legal profession, Adam Kilgore of the Mississippi Bar will be giving away free, round-trip plane tickets to the North Pole where they keep their bar complaint forms (which are NOT available online). If you don't want to go to the North Pole, you can enjoy Brant Brantley's (of the Mississippi Commission on Judicial Performance) free guided tours of the quicksand field over by High Street where all complaints against judges disappear. If for some reason you are unable to control yourself, never fear; Judge Houston Patton will operate his jail where no lawyers are needed or allowed as you just sit there for minutes... hours.... months...years until he decides he is tired of you sitting in his jail. Do not think Judge Patton is a bad judge however as he plans to serve free Mad Dog 20/20 to all inmates.

Trollfest '09 is a pet-friendly event as well. Feel free to bring your dog with you and do not worry if your pet gets hungry, as employees of the Jackson Zoo will be on hand to provide some of their animals as food when it gets to be feeding time for your little loved one.

Relax at the Fox News Tent. Since there are only three blonde reporters in Jackson (being blonde is a requirement for working at Fox News), Megan and Kathryn from WAPT and Wendy from WLBT will be on loan to Fox. To gain admittance to the VIP section, bring either your Republican Party ID card or a Rebel Flag. Bringing both and a torn-up Obama yard sign will entitle you to free drinks served by Megan, Wendy, and Kathryn. Get your tickets now. Since this is an event for trolls, no ID is required. Just bring the hate. Bring the family, Trollfest '09 is for EVERYONE!!!

This is definitely a Beaver production.

Note: Security provided by INS.

Trollfest '07

Jackson Jambalaya is the home of Trollfest '07. Catch this great event which promises to leave NE Jackson & Fondren in flames. Sonjay Poontang and his band headline the night with a special steel cage, no time limit "loser must leave town" bout between Alan Lange and "Big Cat"Donna Ladd following afterwards. Kamikaze will perform his new song F*** Bush, he's still a _____. Did I mention there was no referee? Dr. Heddy Matthias and Lori Gregory will face off in the undercard dueling with dangling participles and other um, devices. Robbie Bell will perform Her two latest songs: My Best Friends are in the Media and Mama's, Don't Let Your Babies Grow up to be George Bell. Sid Salter of The Clarion-Ledger will host "Pin the Tail on the Trial Lawyer", sponsored by State Farm.

There will be a hugging booth where in exchange for your young son, Frank Melton will give you a loooong hug. Trollfest will have a dunking booth where Muhammed the terrorist will curse you to Allah as you try to hit a target that will drop him into a vat of pig grease. However, in the true spirit of Separate But Equal, Don Imus and someone from NE Jackson will also sit in the dunking booth for an equal amount of time. Tom Head will give a reading for two hours on why he can't figure out who the hell he is. Cliff Cargill will give lessons with his .80 caliber desert eagle, using Frank Melton photos as targets. Tackleberry will be on hand for an autograph session. KIM Waaaaaade will be passing out free titles and deeds to crackhouses formerly owned by The Wood Street Players.

If you get tired come relax at the Fox News Tent. To gain admittance to the VIP section, bring either your Republican Party ID card or a Rebel Flag. Bringing both will entitle you to free drinks.Get your tickets now. Since this is an event for trolls, no ID is required, just bring the hate. Bring the family, Trollfest '07 is for EVERYONE!!!

This is definitely a Beaver production.

Note: Security provided by INS