Thursday, November 8, 2018

UMMC to Begin CBD Oil Trials

UMMC issued the following statement.


A clinical trial of a new drug derived from marijuana to treat seizures in children has received approval, and patients are receiving the medication, according to the physician directing it.

Following a rigorous review process, the trial is being conducted by the University of Mississippi Medical Center and the UM School of Pharmacy on UMMC’s Jackson campus.
The study’s focus is to determine the safety and tolerability of the medication for children with severe epilepsy whose seizures are uncontrolled by other means, said principal investigator Dr. Brad Ingram, UMMC associate professor of pediatric neurology and director of the Pediatric Comprehensive Epilepsy Program.
Ingram described the six-month trial, which involves 10 patients, as “compassionate care” for “the sickest of the sick.”
“These 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.
Required approvals were obtained from the Drug Enforcement Agency and the Food and Drug Administration. The clinically tested investigational drug product is an oral cannabidiol, CBD for short, derived from marijuana grown at the UM School of Pharmacy’s National Center for Natural Products Research.
Dr. Richard Summers, UMMC associate vice chancellor for research, said, “Approval of a first phase clinical trial of cannabidiol oil in patients with seizures that are not controlled with conventional treatments is a milestone for our translational research efforts at UMMC. In this study, extracts of a plant grown on the Oxford campus are being practically translated into a potential new therapy for patients who suffer a debilitating illness.”
The oral solution consists of a CBD extract manufactured at NCNPR’s Coy Waller Laboratory, home of the Marijuana Project led by Drs. Mahmoud ElSohly and Ikhlas Khan. 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.
Once the extract is manufactured, packaged and checked to ensure it meets all quality control specifications, it is transferred to the pharmacy at UMMC’s main campus in Jackson. There, the extract is diluted with pharmaceutical-grade sesame seed oil to achieve the proper dosage concentration for administration to patients.
Dr. Larry Walker, director emeritus of the NCNPR, 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. 
Walker said the partnership between NCNPR and UMMC opens the door to progress. “Dr. 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.”
This trial will allow a more rigorous scientific, quality-controlled study of the plant’s medicinal use because of the federally regulated consistency of the product, officials said.
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.  
“UMMC is the site for so many firsts,” said Sen. Josh Harkins, R-Flowood, who authored the bill. “We’d like to see this first, a trial of an investigational new drug product developed at the University of Mississippi and tested at the University of Mississippi Medical Center, result in improved treatments for children with epilepsy.”
Said Ingram: “If we can improve, even in a small way, the life of a child with severe epilepsy, then isn’t it worth a try?”
Kingfish note: Nice.  Now what about CBD oil for sissies otherwise known as cancer patients?

26 comments:

BH said...

Mississippi is surprisingly progressive (for a Southern state) when it comes to medical marijuana and decriminalization. Wouldn't it be something if we were the first Southern state to fully legalize it and reap the tax benefits?

Anonymous said...

Oh great. Four years after passing the CBD oil law, it finally *might* be available to *10 PATIENTS* What a joke. Josh Harkins and the Governor, who received a lot of press for passing "Harper Grace's Law" should be ashamed and demand real availability. I'm glad there is a push to put this on the ballot. I have a family member who had debilitating seizures and was never able to access this medicine. I hope they are able to pass it for those who are still suffering.

Anonymous said...

Big congratulations to Senator Josh Harkins who has worked for years, first to get legislation passed to allow for this trial and then to stay on top of it while fighting to get DEA and FDA approvals of the trial.

Over/under - how long will it be until SOS Hosemann steps up with a press conference somehow tying himself into this process and taking credit? 36 hours, 24 hours....?

Anonymous said...

CBD alone will not stop seizures, nor will it alleviate intense pain. it takes a combination of CBD AND THC which is the psychogenic. This has been proven time and time again in Great Britain and in other states.

StarRider said...

These compounds seem to show a lot of promise in treating seizures, hopefully this will prove to be a productive line of research. From what I hear the appetite-inducing effects are well known.

Anonymous said...

Never smoked a joint in my life, and likely never will. I've always avoided drugs, even marijuana.

That said, I think Mississippi should legalize and tax it. We should allow it to be sold in a method similar to alcohol - through regulated and licensed outlets. I never thought I would be in favor of legalization, but after seeing that there has been no significant adverse effect in CO and WA, I think we need to go ahead.

Anonymous said...

It's crazy that the state leaders act like marijuana is some toxic plant. It's relatively benign and great for a ton of ailments. Have they ever fucking traveled to Colorado? It's really no big deal, and it would sure be a shot in the arm for small business opportunity and tax revenues. And adults who want a safer medicine.

Anonymous said...

Not sure why they are doing this. The DEA has weed listed as a Schedule 1 drug which means it has no medicinal value. I guess these doctors just want to waste their time looking for a medicinal purpose even though the government already studied it and said there isn't one. Leave the weed studies up to the countries that are ok with it, like Canada and Mexico. I'm sure Trump has studied the issue as well and he knows best and says there is no medicinal value otherwise he would have changed it from schedule 1.

Anonymous said...

https://denver.cbslocal.com/2015/09/15/feds-release-marijuana-stats-to-show-negative-effects-of-legalization/

Having regulated medication is one thing -- but full legalization another. Read the FEDERAL report from OBAMA 2015 -- I'm sure back then the content was heavily regulated and still negative regarding legalization and the effects. I guess everyone wants their 35 year old kid in the basement "dreaming" of what they'll do and become when they "grow" up.

"Mom -- can you roll me another joint and send me a ham sandwich??"

Anonymous said...

Drive a few blocks to the Cbd store pick up several different types of Cbd and cbg, once a month. In six months I’m down to one non narcotic med from 6 meds. Stuff works. I haven’t had a seizure since and there is no psychotic component. Frankly, if there was THC in it and it worked as well, I would do that too. The meds worked sometimes but the side effects are awful. Cbd has no discernible side effects.

Anonymous said...

CBD will not help these seizures. These are the same idiots that think vaccines cause autism. Harkins should be ashamed.

Marijuana is for the weak. It is for losers.

If you want to smoke it it take it, be my guest. Just please sign a waiver that you will pay your own medical bills when you get lung cancer. Don’t ask me to take care of you via my taxes.

As for legalization, it’s a joke. Casinos, lottery, pot. All the great savior of the Mississippi tax shortfall. All that cash didn’t fix anything. I’m not against the lottery or casinos, but the tax infusion they supposedly provide still isn’t enough.

Anonymous said...

Josh Harkins needs to stop posting anonymously. Its obviously him.

Anonymous said...

@6:09 - Quite a troll, or never heard of Harry Anslinger. I can't tell, so good job.

Anonymous said...

God made marijuana. Take it up with God.

An Ordinary Millsaps Professor said...

Faaar out!

Anonymous said...

I assume CBD oil is available elsewhere. I have a friend who has brain cancer who takes it. I have never discussed where he gets it. He is not a part of any study, just getting relief through the drug as they give him chemo.

Anonymous said...

@11:49 I hope your friend's treatment is a success.... I would support him being able to take or use anything he wants or needs to make that treatment more tolerable.

Rhinestone Cowgirl said...

If Trump favors it, Cindy will lead the charge. A lifelong conservative who has supported Trump all the way.

Anonymous said...

7:27, I agree. While we are at it, we need a new prohibition that takes out alcohol, tobacco, sugar, and trans fats. Unfortunately these fat drunk losers out there can’t keep their hands out of the cubbard and it’s tanking out healthcare. The general population just can’t have certain freedoms and we need to do something about it. I know trump is not a drinker and look at how great he is and healthy. Take your cancer treatment like a man and stop whining!

Kingfish said...

Didn't approve a long comment. Nothing wrong with the comment, just belongs in the Senate race post, had nothing to do with CBD. Just post it in one of the Senate race threads. Thanks.

Anonymous said...

GW Pharmaceuticals in UK has recently received approval from FDA for its CBD product Epidiolex for the treatment of seizures. As a result, CBD was declassified from Schedule 1 to Schedule 5. Cannabis has been used for its medicinal purposes for centuries. It has been illegal in USA for less than 100 years due to politics. Many other disease states and indications will be treated by cannabis. Corbus Pharma is in Phase 3 with CBD drug for auto-immune disorders for which there are no approved drugs currently. Unfortunately, Mississippi, which had the center at Ole Miss for decades has already fell behind.

Grammar Hammer said...

Alumni is a plural noun referring either to a group male graduates or to a group of both male and female graduates.

The singular alumnus refers to one male graduate, alumna refers to one female graduate, and the plural alumnae refers to a group of female graduates.


Thank you. Thank you!

It always cracks me up to hear a college graduate say "I'm an alumni of ________." Yeah? Well, speak with the vocabulary of someone who went to college. It's not that hard. I remember when former Bama QB and current SEC Network analyst was selected to be a Rhodes Scholar. (He opted to try his hand at pro football instead.) He tweeted, "I'm so proud to be an alumni of the University of Alabama." I thought, "They should rescind the offer."

The same kind of people say stuff like "...between you and I."

Instant indicator.

Anonymous said...

Some form, not sure whether CBD or THC, is available through veterinarians for our pets. They didn't have to wade through the pharmaceutical greed. Their is also a milder Copaiba essential oil available to the general public.

P.S. Doesn't 3:26 belong on the Vitter thread?

Illuminahtee said...

3:26 - How often do you see a sticker on the back of an F-150 that reads "MSU Alumnus"...or a BMW that reads "OM Alumnus"? ...Which leads people to think they're an alumni...instead of just a Mississippi hick who went to college.

Anonymous said...

To the guy who said God created marijuana, he also made people with free will who later become idiots for using marijuana. Typical liberal talking point - “blame God, religion, and faith for all kinds of hypocrisy.”

nick middleton said...

One of the main areas of focus for JustCBD is providing a convenient delivery method for their customers. cbd oil

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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.


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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.

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