“GW Pharmaceuticals Commences Phase 1Clinical Trial of GWP42006” (to be marketed as “Epidiolex”),”as a Potential Treatment for Epilepsy”

EPIDIOLEX

“GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW”) announced today it has commenced a Phase 1 clinical trial of product candidate GWP42006 for the treatment of epilepsy.

Over the last five years, GW has conducted an extensive pre-clinical cannabinoid research program in the field of epilepsy in collaboration with the University of Reading in the United Kingdom. This research has led to the emergence of a number of promising cannabinoid therapeutic candidates showing anti-epileptic effects.

GWP42006, one of the most promising of those candidates, is a non-psychoactive cannabinoid extracted from specific chemotypes of the cannabis plant which has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs1.

“We are pleased to have advanced GWP42006 to first dose in man, a significant milestone in the development of this novel product candidate. The decision to progress into Phase 1 follows several years of highly promising pre-clinical research,” stated Dr. Stephen Wright, Director of Research and Development at GW. “We believe that GWP42006 has the potential to become an important advance in the treatment of epilepsy, a condition for which there remains a substantial unmet medical need.””

More: http://www.gwpharm.com/Phase1Epilepsy.aspx

“GW Pharma Commences Phase 1 Clinical Trial Of GWP42006 For Treatment Of Epilepsy… GWP42006, is a non-psychoactive cannabinoid extracted from specific chemotypes of the cannabis plant which has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs.” http://www.nasdaq.com/article/gw-pharma-commences-phase-1-clinical-trial-of-gwp42006-for-treatment-of-epilepsy-20130918-00037

“A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects…This study is currently recruiting participants.” http://clinicaltrials.gov/show/NCT01918735

“Driving directions to GW Pharma Limited and product information about EPIDIOLEX is provided. EPIDIOLEX is a product created by GW Pharma Limited in  Porton Down Science Park , Salisbury, , SP4OJR. The EPIDIOLEX  is a product related to Pharmaceutical and veterinary preparations and substances for the treatment of epilepsy, convulsions, seizures, Dravet syndrome, Lennox-Gastaut syndrome, intractable childhood epilepsy with generalized tonic-clonic seizures, generalized epilepsy with febrile seizures plus, Doose syndrome and chromosome disorders; pharmaceutical preparations and substances for the treatment of pediatric epilepsy; herbs for medicinal purposes; medicinal herbs; medicinal oils; medicinal infusions for the treatment of epilepsy; pure extracts of medicinal plants and herbs used for the treatment of epilepsy, convulsions and seizures; herb teas for medicinal purposes. The EPIDIOLEX product is now being marketed in the United States for sale. The EPIDIOLEX is in the category of  Pharmaceutical Products..

Get in contact with the owner, GW Pharma Limited of this EPIDIOLEX, or visit them at their place of business in the map. Write a review about the product with this EPIDIOLEX.

Or, contact the owner GW Pharma Limited of the  EPIDIOLEX trademark by filing a request to communicate with the Legal Correspondent   for licensing, use, and/or questions related to EPIDIOLEX. The correspondent of the EPIDIOLEX is  MICHELLE L. VISSER of RADER, FISHMAN & GRAUER PLLC, 39533 WOODWARD AVE STE 140, BLOOMFIELD HILLS, MI 48304-5098 “.

http://www.trademarkia.com/map/epidiolex-86007888.htm

Comes Now Epidiolex™ (FDA approves IND studies of CBD)

NYU Conference

“In response to urgent need expressed by parents of children with intractable epilepsy, the U.S. Food and Drug Administration is allowing Investigational New Drug studies of purified CBD (cannabidiol) as an anti-seizure medication. The “new drug” is being provided to physician-investigators by GW Pharmaceuticals, which has named its CBD product “Epidiolex™.”

More: http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/

New Cannabis Drug Approved For Trials In Children With Epilepsy

 (Photo: GW Pharmaceuticals)
 
 

“New Cannabis Drug Approved For Trials In Children With Epilepsy

 

A new cannabis-based drug made by GW Pharmaceuticals has been approved by the U.S. Food and Drug Administration (FDA) for two separate trials involving children with epilepsy.

The drug is made from purified cannabidiol (CBD) – a non-psychoactive compound in marijuana – and is being marketed under the name Epidiolex, reports O’Shaughnessy’s.

So far, the FDA has approved two Investigational New Drug studies of Epidiolex for pediatric epilepsy, which are being led by Orrin Devinsky, MD, at the NYU School of Medicine, and Roberta Cilio, MD, PhD, at the University of California, San Francisco (UCSF). Each will involve 25 children with epilepsy, and other studies are awaiting approval.

If all goes as planned, GW Pharmaceuticals’ Chairman Geoffrey Guy, MD, expects more studies to begin within months.

“In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the U.S., each treating a couple of dozen patients with various epilepsies.”

GW Pharmaceuticals is best known for its cannabis-based spray called Sativex, which is approved in over 20 countries for the treatment of multiple sclerosis symptoms.

However, the company has spent recent years developing a drug for epilepsy. Preclinical studies sponsored by the company show that CBD, along with a related cannabinoid called CBDV, have the potential to reduce epileptic seizures. Anecdotal reports also suggest that CBD-rich cannabis extracts could be effective in treating epilepsy in children.

Unlike Sativex, Epidiolex is a liquid medicine that can be administered with a syringe dropper. According to the company, the drug contains more than 98 percent CBD, along with trace amounts of other cannabinoids.”

More: http://www.leafscience.com/2013/10/22/new-cannabis-drug-approved-trials-children-epilepsy/

“Comes Now Epidiolex™ (FDA approves IND studies of CBD)” http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/

Therapeutic potential of cannabinoid medicines.

Drug Testing and Analysis

“Cannabis was extensively used as a medicine throughout the developed world in the nineteenth century but went into decline early in the twentieth century ahead of its emergence as the most widely used illicit recreational drug later that century. Recent advances in cannabinoid pharmacology alongside the discovery of the endocannabinoid system (ECS) have re-ignited interest in cannabis-based medicines.

The ECS has emerged as an important physiological system and plausible target for new medicines. Its receptors and endogenous ligands play a vital modulatory role in diverse functions including immune response, food intake, cognition, emotion, perception, behavioural reinforcement, motor co-ordination, body temperature, wake/sleep cycle, bone formation and resorption, and various aspects of hormonal control. In disease it may act as part of the physiological response or as a component of the underlying pathology.

In the forefront of clinical research are the cannabinoids delta-9-tetrahydrocannabinol and cannabidiol, and their contrasting pharmacology will be briefly outlined. The therapeutic potential and possible risks of drugs that inhibit the ECS will also be considered. This paper will then go on to review clinical research exploring the potential of cannabinoid medicines in the following indications: symptomatic relief in multiple sclerosis, chronic neuropathic pain, intractable nausea and vomiting, loss of appetite and weight in the context of cancer or AIDS, psychosis, epilepsy, addiction, and metabolic disorders.”

http://www.ncbi.nlm.nih.gov/pubmed/24006213

http://onlinelibrary.wiley.com/doi/10.1002/dta.1529/abstract

Family: medical marijuana could help son with rare disease

 “”Everybody loves Charlie,” boasted father, Eric Byrd,”he’s just always smiling, it’s his personality, he just glows.”

Charlie Byrd looks like every little five-year-old boy and has a smile that will melt your heart. But Charlie is in a dangerous battle for his life against a rare, and even deadly, form of epilepsy called “Dravet Syndrome.”

“He keeps smiling and he doesn’t even know that he’s sick,” said Crystal Byrd, Charlie’s mother, through tears.

The Byrds say the first seizure happened when Charlie was just a few months old, the second came just a few months later when he was six months old. From there the hospital trips added up, as did the pain and the seizures.

“We quit counting, it had become a little hard to deal with,” stated Charlie’s mom.

The Byrds have given their only son everything they can find.

“We’ve tried numerous therapies, medicines, and nothing’s ever worked,” said Eric Byrd, “Today, he’s on four different types of anti-epileptic drugs. This morning he had two seizures in his sleep.”

The West Liberty family even started the young boy on medicine from other countries after doing research. Along the way they connected with other families with children battling “Dravet Syndrome.”

One case stands above the rest. Crystal Byrd pointed to a girl in Colorado who seems to have found a strong remedy, “The child went from 300 seizures to one a week, and sometimes the one-a-week doesn’t even come.”

The medicine, though, is only legal in 19 states and Kentucky isn’t one of them.

“It was the medical marijuana, the CBDs,” answered Crystal.

CBD, or cannabidiol, isn’t like other forms of marijuana, as Crystal explained, she’s not giving her son a cigarette. Instead, she said it can come in the form of an oil or even pill.

“He won’t be high from it, it doesn’t have the taboo marijuana association with it,” she said.

Still, the topic of legalizing marijuana even in medical cases has been, at times, controversial. Yet, it is on the table for politicians to consider in a Wednesday meeting in Frankfort. According to the agenda, advocates for medicinal marijuana, patients, doctors, and even a former narcotics officer will speak before a committee of state lawmakers.

The Byrds are anxious. They say if medical marijuana isn’t allowed, then they might be looking to move to a state that does allow it, like Colorado.

“I can see through conservatory, but I mean how can you look at him and not want to give him a chance?” asked Crystal Byrd.”

http://www.wkyt.com/home/headlines/Family-medical-marijuana-could-help-son-with-rare-disease-220452801.html

Marijuana stops child’s severe seizures

 

“Saundra Young of CNN.com delved into the heated debate of medical marijuana and children, in her story about a little girl who has a rare, and severe form of epilepsy called Dravet Syndrome. While the debate continues, the pro-legalization side may have won a small victory in the form of Charlotte Figi, 6, who was given her life back by marijuana…

Desperate for a treatment, Charlotte’s father Matt searched the Internet and eventually found a boy with a similar case in which medical marijuana helped his seizures. The Figi’s turned to the Stanley brothers, one of Colorado’s largest marijuana growers and dispensary owners, for help.

“These six brothers were crossbreeding a strain of marijuana low in THC, the compound in marijuana that’s psychoactive, and high in CBD, which has medicinal properties but no psychoactivity,” writes Young. But the Stanley brothers didn’t know what to do with this particular strain, as no one seemed to want to buy it. Then they met Charlotte.

The first time Charlotte tried a small dose of cannabis oil, the results were astounding:

“When she didn’t have those three, four seizures that first hour, that was the first sign,” Paige recalled. “And I thought well, ‘Let’s go another hour, this has got to be a fluke.'”

The Stanley brothers started the Realm of Caring Foundation, a nonprofit organization that provides this particular strain of medical marijuana to adults and children suffering from a host of diseases. The strain used by Charlotte and 41 other patients is affectionately called Charlotte’s Web.

Charlotte’s seizures stopped for seven days after her first dose and today she is eating, and walking on her own — even riding a bike, her parents say. Charlotte gets a dose of the cannabis oil twice a day in her food and her seizures are down to 2 to 3 per month.

“I literally see Charlotte’s brain making connections that haven’t been made in years,” Matt said. “My thought now is, why were we the ones that had to go out and find this cure? This natural cure? How come a doctor didn’t know about this? How come they didn’t make me aware of this?”

Read the full article on CNN.com.”

More: http://www.philly.com/philly/health/Marijuana_stops_childs_severe_seizures.html

Modesto, Calif. dad turns to medical marijuana to save son

“Jason David from Modesto chronicles the ups and downs with his 6-year-old son Jayden, who was diagnosed with Dravet syndrome, on a Facebook page called Jason and Jayden’s Journey.” https://www.facebook.com/jasonandjaydensjourney

“Jayden was diagnosed with Dravet, a rare form of epilepsy, when he was a baby. Since then, he has had seizures preventing him from walking, playing and living life.

“At one point Jayden had seizures 24 hours a day lasting an hour and a half,” David said. “I went to my doctor and said, ‘I don’t think Jayden is going to last, he can’t sleep, can’t eat, he hasn’t used the restroom, he can’t do anything.'” 

David said his son has been taken away in an ambulance more than 40 times. He’s also taken 22 pills a day — 12 different kinds and none of them worked.

David said it got so bad that he wanted to kill himself and put a gun to his head.

But now, those thoughts are long gone.

As a last resort, David turned to medical marijuana. Specifically, a liquid form that contains a component known as CBD.

Jayden’s pediatrician prescribes it to Jayden and says the liquid form maintains medicinal qualities, while giving less of a high.

Jayden has been getting a few drops a day for the past two years and David said it’s been a remarkable difference.

Jayden is the most independent he’s ever been. He plays well, can walk and give his dad high fives, David said.

“(The) first day I gave him medical marijuana, thank God. (It was) the first day he went seizure free in his life,”he said.

David said he wants to share his story to help other parents in the same situation.

He says parents need to educate themselves and do what’s right for their own children.

The father and son have been featured in numerous articles and television shows. Jason and Jayden will be featured as a small piece in a special about medical marijuana with Dr. Sanjay Gupta that airs Sunday on CNN.

Jayden’s pediatrician said he is seeing more children with autism and seizures who are benefiting from medical marijuana.

The doctor admits not a lot of studies have been done on medicinal marijuana, which is why doctors across the board may have differing opinions.

However, doctors at the University of California-San Francisco are now studying the affects the CBD component in medical marijuana has on epileptic children.”

http://www.kcra.com/news/modesto-calif-dad-turns-to-medical-marijuana-to-save-son/-/11797728/21403126/-/item/0/-/12mmupr/-/index.html

Dad says marijuana saved his 6-year-old son’s life – msn

“”Miraculous” stories from people who say medical marijuana helped them when all else failed keep rolling in.”

Still of father and son who were saved by THC - via KCRA, http://aka.ms/dope-cure

“The latest? A 6-year-old boy from Modesto, Calif., named Jayden David. Just like a young girl in Colorado, he suffers from a rare form of epilepsy called Dravet Syndrome. The disorder gave Jayden seizures so severe and frequent, he couldn’t walk, play or do much of anything. He often had to be rushed to the hospital by ambulance. Doctors prescribed as many as 22 pills a day. Nothing worked. “At one point Jayden had seizures 24 hours a day lasting an hour and a half,” his father, Jason David, told local station KCRA. “I went to my doctor and said, ‘I don’t think Jayden is going to last. He can’t sleep, can’t eat. He hasn’t used the restroom. He cant do anything.'”

With no alternate options, the doctor prescribed a liquid form of cannabis called CBD, which gives less of a high. It was the first day of his entire life that Jayden went seizure-free. In the two years since, he’s taken CBD daily and now walks, plays and laughs happily. Jason credits medical marijuana with saving his son’s life — and says he’s speaking out now to help other parents with children in Jayden’s situation. “How can I not tell people, ‘Hey, save your children’s lives?'” he asks.”

http://now.msn.com/jayden-david-6-was-saved-by-medical-marijuana-dad-says

Marijuana Saves Child With Seizures; Others Must Wait

“Parents of a 5-yr-old Colorado girl who suffered from severe seizures say medical marijuana has saved their child’s life.  Footage of the child before and after she was given cannabis was shown Sunday in a documentary, “Weed,” aired on CNN hosted by Sanjay Gupta, a neurosurgeon.
 

Buoyed by previously published reports and You-Tube videos of the child’s remarkable recovery, several New Jersey parents have been pushing for the opportunity to give cannabis to their seriously ill children.   They want Gov. Christie to sign a bill that would pave the way. 

Paige and Matt Figi said in the CNN interview that their daughter, Charlotte, had 300 seizures a week before she was administered drops of cannabis under her tongue a year ago.  She had been in a catatonic state, unable to eat, talk, or walk.  Now, after regularly using cannabis, she has only one seizure every seven days, the parents said.  Footage shows her talking, walking, laughing, riding a bicycle and also a horse. 

Forty-one other children had similar results, according to the documentary. 

Gupta traveled around the world, interviewing other seriously ill patients who got astonishing  results by using cannabis.  In Israel, some studies show the drug has helped sufferers of Crohn’s Disease, Post-Traumatic Stress Disorder and cancer. 

There also are detractors – doctors who say not enough research has been done, as interviewed by Gupta.  The American Academy of Pediatricians also oppose giving it to children.  

Meghan and Brian Wilson, the parents of two-year-old Vivian, who live in Scotch Plains, in North Jersey, have spent the last few months lobbying to get changes in New Jersey’s three-year-old marijuana law to make it easier for children to use cannabis.  It’s legal in the state for children to use it – in fact Vivian was issued a marijuana card in February because she too suffers from a severe type of epilepsy.  But cannabis is not allowed to be sold in edible form and requires three doctors to sign off on it before a child can obtain it. 

A bill that was overwhelming passed by the legislature is sitting on Gov. Christie’s desk.  He has said he is reluctant, but will consider it.  He has until Friday, Aug. 16, to decide.

It’s not known whether Christie watched the CNN documentary.” 

http://www.philly.com/philly/news/new_jersey/Marijuana-Saves-Child-With-Seizures-Others-Must-Wait–.html

Medical marijuana stopped girl’s seizures when nothing else would – msn

Photo of Charlotte Figi - Realm of Caring via Facebook

 

“Charlotte Figi had her first seizure in 2006, when she was 3 months old. Her parents, Matt and Paige Figi, had every test conducted, yet no cause could be found. Years passed, and the seizures continued. Charlotte took medications, but she stopped developing cognitively. She was finally diagnosed with a severe form of epilepsy, Dravet Syndrome. Matt discovered the case of a boy with Dravet who’d been helped by low-level THC medical marijuana. By that point, Charlotte couldn’t walk, talk or eat, and she was having up to 300 grand mal seizures a week.

Desperate to find a solution, Matt and Paige applied for a medical marijuana card, making Charlotte, then 5, the youngest applicant in Colorado. They gave her a small amount of cannabis oil. The seizures stopped. Now Charlotte takes the oil twice daily with food, has only a few seizures a week, and is walking, talking and riding her bike. “My thought now is why were we the ones that had to go out and find this cure? This natural cure?” says Matt. “How come [a doctor] didn’t make me aware of this?””

http://now.msn.com/charlotte-figi-colorado-girl-has-seizures-treated-by-medical-marijuana

“Meet the first 6-year-old medical marijuana user” http://fox2now.com/2013/08/12/meet-the-first-6-year-old-medical-marijuana-user/