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.”

nickmiddleton010 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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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!!!

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