Tag Archives: Cannabinoids

FDA approves marijuana based drug

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“The U.S. Food and Drug Administration has approved clinical trials of a cannabis-based drug and its effects on epilepsy. The treatment, Epidiolex, is 98 percent purified cannabidiol (CBD) made by GW Pharmaceuticals based out of the U.K.  

There are around 60 known chemicals contained in cannabis called cannabinoids. Tetrahydrocannabinol, also known as THC, is the main component responsible for the drug’s psychoactive nature. CBD, however, is the second most abundant cannabinoid in the cannabis and provides medicinal benefits without the “high.” Epidiolex will come in a viscous liquid form to be dispensed from syringes. A 25 milligram per meter or 100 milligram per meter will be the two strengths made available to those in the trials.

The FDA has approved of intermediate-sized clinical trials sponsored by two doctors. Dr. Orrin Devinsky, a professor in the Department of Neurology, Neuroscience and Psychiatry in the New York University School of Medicine and director of the NYU Comprehensive Epilepsy Center, and Dr. Roberta Cilio, a pediatric neurologist at the University of California, San Francisco, are set to follow 25 patients using Epidiolex as treatment for pediatric epilepsy.

On Oct. 4, at the NYU Langone Medical Center, Devinsky led a conference entitled, “Cannabidiols: Potential Use in Epilepsy & Other Neurological Disorders.” During the affair, Devinsky and Cilio led a presentation on planned trials on CBD in children with treatment resistant epilepsy. 

The D.C. – based Marijuana Policy Project’s Communications Director Mason Tvert responded to the news of the approved trials. “We’ve long known that marijuana has a variety of medical benefits,” Tvert said. Tvert added that the federal government clearly recognizes marijuana’s medicinal benefits and it’s a shame they hindered most research of it.

Maryland’s new marijuana law came into effect on Oct. 1, but its miniscule scope won’t have much effect. It deals with a small number of patients that would enroll in state-approved clinical studies. However, with no hospitals signed up to hold these studies, no visible changes are set to occur in the near future.

Now the country will wait and see if CBD can live up to the hype, and if the epileptic patients can find any relief from their disease.”

 By Bonnie Katz

http://www.thesentinel.com/mont/news/FDA-approves-marijuana-drug10-31-2013

“Cannabis-Based Epilepsy Drug Approved For Clinical Trials” http://www.medicaljane.com/2013/10/23/cannabis-based-epilepsy-drug-approved-for-clinical-trials/

Around The World, Researchers Begin Clinical Trials of Cannabis For Epilepsy

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Many patients in the U.S. have turned to tinctures and oil extracts to help control their seizures (Photo: Luis Sinco/Los Angeles Times) 
 

“While a large body of anecdotal and laboratory evidence points to cannabis as an effective treatment for epilepsy, research in humans is just beginning to catch up.

 GW Pharmaceuticals – the UK-based company behind the natural cannabis spray Sativex – announced the start of the first round of clinical trials of a new cannabis treatment for epilepsy.

In the press release, Dr. Stephen Wright, Director of Research and Development at GW, said the company has spent years testing cannabis in pre-clinical models – which include cell cultures and animals.

So far, the drug is only known as GWP42006.

“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.”

Dr. Ben Whalley, Senior Lecturer in Pharmacology at the Reading School of Pharmacy, added, “Our research collaboration with GW over the last several years has shown that GWP42006 not only exerts significant anticonvulsant effects in a wide range of preclinical models of seizure and epilepsy but is also better tolerated compared to existing anti-epileptic drugs.”

While the company has not disclosed the ingredients in the new drug, their latest animal study – which appears in the October issue of the British Journal of Pharmacology – showed positive results with two chemicals derived from cannabis: Cannabidiol (CBD) and cannabidivarin (CBDV).

Both were found to suppress seizures and increase survival across a range of different rat models of epilepsy.”

More: http://www.leafscience.com/2013/09/20/around-world-researchers-begin-clinical-trials-cannabis-epilepsy/

Both CBD and CBDV are produced naturally by cannabis. Unlike THC, these two compounds do not get patients high.

“Both CBD and CBDV are produced naturally by cannabis. Unlike THC, these two compounds do not get patients high.”

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

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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

Study: Cannabis Compounds Can Kill Cancer Cells – US News & World Report

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“Researcher says cannabinoids might treat cancer as well as billion-dollar drugs.”

A medical marijuana activist holds a sign during a rally Jan. 4, 2010, in Oakland, Calif. Research suggests marijuana may fight cancer itself, not just side-effects.“A British researcher has found that cannabinoids, a term for chemicals derived from marijuana, can kill leukemia cells, and he expects clinical trials for new medications to begin soon.

The findings, published in the October issue of Anticancer Research: International Journal of Cancer Research and Treatment, show that certain non-psychoactive cannabinoids “resulted in dramatic reductions in cell viability” and “caused a simultaneous arrest at all phases of the cell cycle,” according to an abstract posted online. 

The study tested six cannabinoids, together and independently, on leukemia cells. Study author Wai Liu, an oncologist at the University of London’s St. George’s medical school, told U.S. News the chemicals displayed “potent anti-cancer activity” and, significantly, “target and switch off” pathways that allow cancers to grow.”

More: http://www.usnews.com/news/articles/2013/10/24/study-cannabis-compounds-can-kill-cancer-cells

Endocannabinoid system and pain: an introduction.

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“The endocannabinoid (EC) system consists of two main receptors: cannabinoid type 1 receptor cannabinoid receptors are found in both the central nervous system (CNS) and periphery, whereas the cannabinoid type 2 receptor cannabinoid receptor is found principally in the immune system and to a lesser extent in the CNS.

 The EC family consists of two classes of well characterised ligands; the N-acyl ethanolamines, such as N-arachidonoyl ethanolamide or anandamide (AEA), and the monoacylglycerols, such as 2-arachidonoyl glycerol. The various synthetic and catabolic pathways for these enzymes have been (with the exception of AEA synthesis) elucidated.

 To date, much work has examined the role of EC in nociceptive processing and the potential of targeting the EC system to produce analgesia.

Cannabinoid receptors and ligands are found at almost every level of the pain pathway from peripheral sites, such as peripheral nerves and immune cells, to central integration sites such as the spinal cord, and higher brain regions such as the periaqueductal grey and the rostral ventrolateral medulla associated with descending control of pain. EC have been shown to induce analgesia in preclinical models of acute nociception and chronic pain states.

 The purpose of this review is to critically evaluate the evidence for the role of EC in the pain pathway and the therapeutic potential of EC to produce analgesia. We also review the present clinical work conducted with EC, and examine whether targeting the EC system might offer a novel target for analgesics, and also potentially disease-modifying interventions for pathophysiological pain states.”

http://www.ncbi.nlm.nih.gov/pubmed/24148358

Systematic review of the literature on clinical and experimental trials on the antitumor effects of cannabinoids in gliomas.

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“To evaluate, through a systematic review of the literature, the antitumoral effects of cannabinoids on gliomas…

  In all experimental studies included, cannabinoids exerted antitumoral activity in vitro and/or antitumoral evidence in vivo in several models of tumor cells and tumors.

The antitumor activity included: antiproliferative effects (cell cycle arrest), decreased viability and cell death by toxicity, apoptosis, necrosis, autophagy, as well as antiangiogenic and antimigratory effects.

 Antitumoral evidence included: reduction in tumor size, antiangiogenic, and antimetastatic effects.

 Additionally, most of the studies described that the canabinnoids exercised selective antitumoral action in several distinct tumor models. Thereby, normal cells used as controls were not affected.

The safety factor in the cannabinoids’ administration has also been demonstrated in vivo.

 The various cannabinoids tested in multiple tumor models showed antitumoral effects both in vitro and in vivo.

 These findings indicate that cannabinoids are promising compounds for the treatment of gliomas.”

http://www.ncbi.nlm.nih.gov/pubmed/24142199

The endocannabinoid system and multiple sclerosis.

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“Multiple sclerosis (MS) is a neurodegenerative disease that is characterised by repeated inflammatory/demyelinating events within the central nervous system (CNS). In addition to relapsing-remitting neurological insults, leading to loss of function, patients are often left with residual, troublesome symptoms such as spasticity and pain. These greatly diminish “quality of life” and have prompted some patients to self-medicate with and perceive benefit from cannabis.

Recent advances in cannabinoid biology are beginning to support these anecdotal observations, notably the demonstration that spasticity is tonically regulated by the endogenous cannabinoid system.

Recent clinical trials may indeed suggest that cannabis has some potential to relieve, pain, spasms and spasticity in MS. However, because the CB(1) cannabinoid receptor mediates both the positive and adverse effects of cannabis, therapy will invariably be associated with some unwanted, psychoactive effects.

In an experimental model of MS, and in MS tissue, there are local perturbations of the endocannabinoid system in lesional areas. Stimulation of endocannabinoid activity in these areas either through increase of synthesis or inhibition of endocannabinoid degradation offers the positive therapeutic potential of the cannabinoid system whilst limiting adverse events by locally targeting the lesion.

 In addition, CB(1) and CB(2) cannabinoid receptor stimulation may also have anti-inflammatory and neuroprotective potential as the endocannabinoid system controls the level of neurodegeneration that occurs as a result of the inflammatory insults.

Therefore cannabinoids may not only offer symptom control but may also slow the neurodegenerative disease progression that ultimately leads to the accumulation of disability.”

http://www.ncbi.nlm.nih.gov/pubmed/18781983

Cannabinoids ameliorate disease progression in a model of multiple sclerosis in mice, acting preferentially through CB1 receptor-mediated anti-inflammatory effects

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“Cannabinoids have been proposed as promising therapeutic agents in MS given their capability to alleviate specific MS symptoms (e.g., spasticity, pain).

Although MS has been considered mainly an inflammatory disorder, recent evidence, however, revealed the importance of neurodegenerative events, opening the possibility that cannabinoid agonists, given their cytoprotective properties, may also serve to reduce oligodendrocyte death and axonal damage in MS.

Thus, the treatment with WIN55,512-2, a potent CB1 and CB2 agonist, was reported to be effective to ameliorate tremor and spasticity in mice with chronic relapsing experimental autoimmune encephalomyelitis, a murine model of MS, but also to delay disease progression in this and other murine models of MS….”

http://www.sciencedirect.com/science/article/pii/S0028390812000500

Control of Spasticity in a Multiple Sclerosis Model is mediated by CB1, not CB2, Cannabinoid Receptors

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Figure 1

“There is increasing evidence to suggest that cannabis can ameliorate muscle-spasticity in multiple sclerosis, as was objectively shown in experimental autoimmune encephalomyelitis models. The purpose of this study was to investigate further the involvement of CB1 and CB2 cannabinoid receptors in the control of experimental spasticity…

Conclusions and Implications:

The CB1 receptor controls spasticity and cross-reactivity to this receptor appears to account for the therapeutic action of some CB2 agonists.

 As cannabinoid-induced psychoactivity is also mediated by the CB1 receptor, it will be difficult to truly dissociate the therapeutic effects from the well-known, adverse effects of cannabinoids when using cannabis as a medicine.

The lack of knowledge on the true diversity of the cannabinoid system coupled with the lack of total specificity of current cannabinoid reagents makes interpretation of in vivo results difficult, if using a purely pharmacological approach.

Gene knockout technology provides an important tool in target validation and indicates that the CB1 receptor is the main cannabinoid target for an anti-spastic effect.”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2189718/

Chemicals in marijuana ‘protect nervous system’ against MS

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Cannabis

“Chemical compounds found in marijuana can help treat multiple sclerosis-like diseases in mice by preventing inflammation in the brain and spinal cord, according to a study reported in the Journal of Neuroimmune Pharmacology.

“Inflammation is part of the body’s natural immune response, but in cases like MS, it gets out of hand,” says Dr. Ewa Kozela of Tel Aviv University, Israel.

“Our study looks at how compounds isolated from marijuana can be used to regulate inflammation to protect the nervous system and its functions.”

Dr. Kozela and colleagues set out to see if the known anti-inflammatory properties of two substances found in marijuana – the cannabinoids known as tetrahydrocannabinol (THC) and cannabidiol (CBD) – could also be applied to the treatment of inflammation associated with MS.

With either THC or CBD, the researchers treated immune cells that specifically target and harm the brain and spinal cord. In response to both chemicals, the immune cells, isolated from paralyzed mice, produced fewer inflammatory molecules, particularly interleukin 17 (IL-17).

Interleukin 17 “is strongly associated with MS and very harmful to nerve cells and their insulating covers,” the researchers say. They conclude:

“The presence of CBD or THC restrains the immune cells from triggering the production of inflammatory molecules, and limits the molecules’ ability to reach and damage the brain and spinal cord.” 

More: http://www.medicalnewstoday.com/articles/267161.php 

 

“Cannabinoids Decrease the Th17 Inflammatory Autoimmune Phenotype” http://link.springer.com/article/10.1007/s11481-013-9493-1