Katelyn Baker
Well-Known Member
Harper Grace is the namesake of Mississippi's Harper Grace's Law adopted in 2014, but that's no guarantee she'll be chosen for the cannabis oil trials it authorized.
She has waited three years to be able to possibly get the cannabis oil to treat her Dravet syndrome, a rare form of epilepsy, but the clinical trials will be limited to a handful of children in Mississippi who suffer from epileptic seizures.
However, Harper Grace's mother, Ashley Peszynski Durval, is hopeful her daughter will be among them.
In 2014, the Mississippi Legislature passed Harper Grace's Law, signed by Gov. Phil Bryant, named after the then 2-year-old Harper Grace Durval. It removed cannabis extract oil from the state's illegal drugs list.
The state has yet to receive final federal approval for clinical trials to be begin.
Dr. Brad Ingram, director of the Pediatric Comprehensive Epilepsy Center at the University of Mississippi Medical Center, said in January that the hospital would submit a 32-page proposal to the U.S. Food and Drug Administration to allow the oil for treatment of five to 10 of the most sick children.
Contacted Monday, Ingram said UMMC has a list of 25-30 patients interested in treatment with the initial research protocol aimed at five to 10 patients.
"Patients selected for the study have not and will not be determined until we are at the appropriate stage of the clinical research," he said. "But when patient selection is first decided, it will be based on our well-defined research protocol. As our applications to the FDA/DEA are focused on a compassionate care usage, we used typical enrollment criteria for pediatric pharmacology epilepsy studies."
Ingram said cannabis oil has never been administered to children in this way, so the study protocol "is thorough and balances patient safety and brain development with possible efficacy in the treatment of severe epilepsy. This, of course, also must be balanced against the total amount of product that we will initially have access to. None of us want to put someone on a drug that makes them better, only to run out a few months later."
UMMC is working with the team in Oxford to have a combined Investigational new drug meeting with the FDA to get approval of the drug product.
"We expect that meeting to be scheduled very soon. That approval has to happen before we can move forward with human testing of any kind. It's not the last step in getting this compound to our patients, but it's a very important one," he said.
Once the initial compassionate use process is completed and researchers determine its effectiveness and side effects, Ingram said he hopes the study can be expanded to include with "with more varied severity of childhood epilepsy."
"At the end of the day, I know everyone can't be put in the study," Durval said Monday. "It would be very selfish of me to say we deserve it only because her name is on the bill and we did all the work. I want Harper to to be in the trial before things get any worse for her. To do preventive maintenance if you will. I believe she has a chance to live somewhat of a normal life. Dravet syndrome will never go away, but maybe with the help of (cannabis oil) she can have a chance to get off all the medications ... Her body has been so polluted since she was 6 months old."
"I just want my sweet girl to have a chance," Durval said. "As her parents, we think about what her future will or should look like. All we are doing is fighting for her, just as any parent in this situation should and would do."
Durval said if they cannot get the cannabis oil in Mississippi, they will try to move to another state where the oil is available if they can afford to move.
Ingram said it will likely be late spring or summer at the earliest before UMMC would receive permission to begin the trial use of cannabis oil on patients.
Ingram said a lot of work has gone into the proposal, but he said federal approval is out of his control.
Conducting clinical research using marijuana involves three federal agencies. This includes: obtaining the marijuana from the National Institute on Drug Abuse within the National Institutes of Health; review of an investigational new drug application and the research protocol by the FDA and an investigator registration and site licensure by the Drug Enforcement Administration.
UMMC said any clinical trial established there would initially involve children with refractory or more serious types of epilepsy. There are no current plans to study the effectiveness of cannabis oil or smoked marijuana on seizure activity in adults.
Lawmakers on both sides of the aisle supported the legislation. Sen. Josh Harkins, R-Flowood, authored the bill.
Another legislative bill was passed this year and is expected to be signed by the governor to allow more pharmacists in the state to dispense the oil when it becomes available.
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Mother Hopes Child Is Picked For Cannabis Oil Trials
Author: Jimmie E. Gates
Contact: (601) 961-7000
Photo Credit: None Found
Website: The Clarion-Ledger
She has waited three years to be able to possibly get the cannabis oil to treat her Dravet syndrome, a rare form of epilepsy, but the clinical trials will be limited to a handful of children in Mississippi who suffer from epileptic seizures.
However, Harper Grace's mother, Ashley Peszynski Durval, is hopeful her daughter will be among them.
In 2014, the Mississippi Legislature passed Harper Grace's Law, signed by Gov. Phil Bryant, named after the then 2-year-old Harper Grace Durval. It removed cannabis extract oil from the state's illegal drugs list.
The state has yet to receive final federal approval for clinical trials to be begin.
Dr. Brad Ingram, director of the Pediatric Comprehensive Epilepsy Center at the University of Mississippi Medical Center, said in January that the hospital would submit a 32-page proposal to the U.S. Food and Drug Administration to allow the oil for treatment of five to 10 of the most sick children.
Contacted Monday, Ingram said UMMC has a list of 25-30 patients interested in treatment with the initial research protocol aimed at five to 10 patients.
"Patients selected for the study have not and will not be determined until we are at the appropriate stage of the clinical research," he said. "But when patient selection is first decided, it will be based on our well-defined research protocol. As our applications to the FDA/DEA are focused on a compassionate care usage, we used typical enrollment criteria for pediatric pharmacology epilepsy studies."
Ingram said cannabis oil has never been administered to children in this way, so the study protocol "is thorough and balances patient safety and brain development with possible efficacy in the treatment of severe epilepsy. This, of course, also must be balanced against the total amount of product that we will initially have access to. None of us want to put someone on a drug that makes them better, only to run out a few months later."
UMMC is working with the team in Oxford to have a combined Investigational new drug meeting with the FDA to get approval of the drug product.
"We expect that meeting to be scheduled very soon. That approval has to happen before we can move forward with human testing of any kind. It's not the last step in getting this compound to our patients, but it's a very important one," he said.
Once the initial compassionate use process is completed and researchers determine its effectiveness and side effects, Ingram said he hopes the study can be expanded to include with "with more varied severity of childhood epilepsy."
"At the end of the day, I know everyone can't be put in the study," Durval said Monday. "It would be very selfish of me to say we deserve it only because her name is on the bill and we did all the work. I want Harper to to be in the trial before things get any worse for her. To do preventive maintenance if you will. I believe she has a chance to live somewhat of a normal life. Dravet syndrome will never go away, but maybe with the help of (cannabis oil) she can have a chance to get off all the medications ... Her body has been so polluted since she was 6 months old."
"I just want my sweet girl to have a chance," Durval said. "As her parents, we think about what her future will or should look like. All we are doing is fighting for her, just as any parent in this situation should and would do."
Durval said if they cannot get the cannabis oil in Mississippi, they will try to move to another state where the oil is available if they can afford to move.
Ingram said it will likely be late spring or summer at the earliest before UMMC would receive permission to begin the trial use of cannabis oil on patients.
Ingram said a lot of work has gone into the proposal, but he said federal approval is out of his control.
Conducting clinical research using marijuana involves three federal agencies. This includes: obtaining the marijuana from the National Institute on Drug Abuse within the National Institutes of Health; review of an investigational new drug application and the research protocol by the FDA and an investigator registration and site licensure by the Drug Enforcement Administration.
UMMC said any clinical trial established there would initially involve children with refractory or more serious types of epilepsy. There are no current plans to study the effectiveness of cannabis oil or smoked marijuana on seizure activity in adults.
Lawmakers on both sides of the aisle supported the legislation. Sen. Josh Harkins, R-Flowood, authored the bill.
Another legislative bill was passed this year and is expected to be signed by the governor to allow more pharmacists in the state to dispense the oil when it becomes available.
News Moderator: Katelyn Baker 420 MAGAZINE ®
Full Article: Mother Hopes Child Is Picked For Cannabis Oil Trials
Author: Jimmie E. Gates
Contact: (601) 961-7000
Photo Credit: None Found
Website: The Clarion-Ledger
