Study To Investigate Link Between Cannabis Compound And Slowing Of Multiple Sclerosis

[grammychronic]

Study To Investigate Link Between Cannabis Compound And Slowing Of Multiple Sclerosis

Main Category: Multiple Sclerosis (http://www.medicalnewstoday.com/sections/multiple_sclerosis/)
Also Included In: Immune System / Vaccines (http://www.medicalnewstoday.com/sections/immune_system/); Neurology / Neuroscience (http://www.medicalnewstoday.com/sections/neurology/); Clinical Trials / Drug Trials (http://www.medicalnewstoday.com/sections/clinical_trials/)
Article Date: 22 Jul 2008 - 4:00 PDT

The CUPID (Cannabinoid Use in Progressive Inflammatory brain Disease) study at the Peninsula Medical School in Plymouth has reached an important milestone with the news that the full cohort of 493 people with multiple sclerosis (MS) has been recruited to the study.

CUPID is a clinical trial which will evaluate whether tetrahydrocannabinol (THC), one of many compounds found in the in the cannabis plant (and the main active ingredient) is able to slow the progression of MS.

The Rest Here:
http://www.medicalnewstoday.com/articles/115748.php

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Drug Watch International
Research Section
Marijuana Chemical Reduces Multiple Sclerosis Pain


NEW YORK (Reuters Health) - Treatment with Marinol, a synthetic version of cannabinoid chemicals found in marijuana, can reduce the pain often experienced by people with multiple sclerosis (MS) new research suggests. The findings, which appear in the British Medical Journal, are based on a study of 24 MS patients with pain who were treated with Marinol or inactive "placebo" for 3-week periods.
Dr. Flemming W. Bach and colleagues, from Aarhus University Hospital in Denmark, found that Marinol was significantly better than placebo at lowering pain intensity and increasing pain relief.
In terms of quality of life, Marinol appeared to offer a benefit over placebo in reducing bodily pain and improving mental health. No change in functional ability was seen with Marinol or placebo.
Marinol was more likely than placebo to produce side effects, particularly during the first week of treatment, the authors note. The most common side effects included dizziness, headache, and tiredness.
"The pain reduction seen in this study is comparable to the effect of other drugs" used in the treatment of related pain conditions, the authors state. Marinol "should be available for patients whose central pain is not sufficiently treated with alternative drugs such as anticonvulsants, antidepressants, or opioids," they add.
SOURCE: British Medical Journal, July 16th online issue, 2004.

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Cannabis for Spasticity in Multiple Sclerosis
This study has been terminated.
Sponsored by: Center for Medicinal Cannabis Research
Information provided by: Center for Medicinal Cannabis Research ClinicalTrials.gov Identifier: NCT00260741
http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif Purpose The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.


Condition (http://clinicaltrials.gov/ct2/help/conditions_desc) Intervention (http://clinicaltrials.gov/ct2/help/interventions_desc) Phase (http://clinicaltrials.gov/ct2/help/phase_desc) Multiple Sclerosis
Drug: Smoked Cannabis
Phase I
Phase II


MedlinePlus (http://www.nlm.nih.gov/medlineplus/) related topics: Marijuana (http://clinicaltrials.gov/ct2/bye/aQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9mB1yeQUHkdNjuQo Pmdt.) Multiple Sclerosis (http://clinicaltrials.gov/ct2/bye/xQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9mi7aWQ13v61g0dh HSd-gewSxlihLv.)
Drug Information (http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp) available for: Cannabis (http://clinicaltrials.gov/ct2/bye/3QoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789VcGudNGpQ1R.) GW-1000 (http://clinicaltrials.gov/ct2/bye/tQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789PLwmRCtERt.)
U.S. FDA Resources (http://clinicaltrials.gov/ct2/info/fdalinks)
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study Official Title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:

Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.



Secondary Outcome Measures:

Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.



Estimated Enrollment: 60 Study Start Date: March 2003 Study Completion Date: January 2006 Detailed Description: The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.




http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif Eligibility

Ages Eligible for Study: 21 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
Inclusion Criteria:


Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
Primary or secondary disease course
Moderate or severe spasticity
Age 21 or older

Exclusion Criteria:


Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
History of or currently meets DSM-IV criteria for dependence on cannabis
Use of cannabis, marijuana, or THC in the last two weeks
Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
Exacerbation of MS within 30 days prior to screenin visit
Current use of cyclophosphamide, mitoxanthrone, or cladribine
Arthritis, bony and soft tissue disorders interfering with spasticity measures
Inability to provide informed consent
Recent cannabis use of more than twice per week one month prior to study entry




http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260741

Locations
United States, California UC Davis Medical Center Sacramento, California, United States, 95817 Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Mark Agius, M.D. University of California, Davis

http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif More Information
Center for Medicinal Cannabis Research (http://clinicaltrials.gov/ct2/bye/8QoPWw4lZXcgmB-nui7gF6Yxz6o8/NVcHuihHSnh6Zwp3g67PeBczuB7EJVcGudNGpQ1RJ8NHF67GSB cJ) http://clinicaltrials.gov/ct2/html/images/frame/exit.bmp

Study ID Numbers: C00-DA-112, 200311404-4 Study First Received: November 30, 2005 Last Updated: April 3, 2007 ClinicalTrials.gov Identifier: NCT00260741 (http://clinicaltrials.gov/ct2/show/NCT00260741) [history] (http://clinicaltrials.gov/archive/NCT00260741) Health Authority: United States: Food and Drug Administration
Keywords provided by Center for Medicinal Cannabis Research: cannabis
marijuana
Multiple Sclerosis
Spasticity


Study placed in the following topic categories: Muscle Spasticity
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Marijuana Abuse
Autoimmune Diseases of the Nervous System


Additional relevant MeSH terms: Pathologic Processes
Immune System Diseases
Nervous System Diseases


ClinicalTrials.gov processed this record on January 28, 2009



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Use of non-psychoactive cannabinoids in the treatment of neurodegenerative diseases 17 September 2008 http://www.msrc.co.uk/images/gallery/img_cannabis.jpg
Scientists at the Complutense University of Madrid (UCM) have studied the effects of a drug that reduces the progression of a disease similar to Multiple sclerosis in animals. This discovery represents another step in the standing fight against the disease.
The research, published in the prestigious Journal of Biological Chemistry, aimed to study in depth the already known effects of lessening the symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743) and stopping the advance of multiple sclerosis that cannabinoids have, while developing a drug that would not have the psychoactive effects of the marijuana plant (Cannabis sativa).
To achieve this, the scientists have focused their study on the role of the cannabinoids receptor CB2, present both in the immune system as well as in the defence-cells of the nervous system (microglial cells).
Multiple sclerosis is a neurodegenerative disease whose causes are not yet fully understood. It is known that the disease is produced by an autoimmune response where the defence-cells in the organism attack and destroy the nerve cells of the organism generating symptoms such as stiffness, twitching, progressive paralysis, etc.
The researchers managed by Professor Ismael Galve from the UCM, founded their conclusions on the role of the cannabinoids receptors in Experimental autoimmune encephalomyelitis, a disease that reproduces some of the proceses and symptoms of multiple sclerosis. In the study it has been tested that administering a drug that activates receptor CB2 (but not CB1, responsible for the psicoactive effects), the sysmptopms of the disease lessen and a reduction of 50% in nerve cell loss was perceived.
This research has introduced yet another novelty: The stimulation of the CB2 receptor not only reduces the excesive activation of brain cells in charge of the defence of the central nervous system, but it allso reduces the supply of new defence-cells that travelling throught the blood stream from bone marrow, would act as reinforcements for the defence-cells of the central nervous system.
According to Ismael Galve, the results are important because the drug is capable of acting in an already sick animal, reducing the symptoms and the brain cell loss. The obtained results, along with other predecessors confirm the role of endogenous cannabinoids in the origin of experimental autoimmune encephalomyelitis and its possible application to multiple esclerosis. Therefore the role of the CB2 receptor in the regulation and neuro-inmune response supports the research currently being carried out on the possible use of cannabinoid drugs in the treatment of neurodegenerative diseases.
The research has been carried out by the department of biochemistry and molecular biology of the Complutense University of Madrid, in collaboration with the Neuroscience research Institute of Lyon in France and the pharmaceutical company Pharmos.
Source: Innovations Report 2000-2008 by innovations-report (17/09/08)

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Marijuana use for chronic pain and nausea (vertigo) 19 August 2008 http://www.msrc.co.uk/images/gallery/img_cannabis.jpg
Smoked marijuana can bring relief to sufferers of neuropathic pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1740) comparable to that of other painkiller drugs, some studies show.
Medical marijuana use has a history stretching back thousands of years. In prebiblical times, the plant was used as medicinal tea in China, a stress antidote in India and a pain- reliever for earaches, childbirth and more throughout Asia, the Middle East and Africa.

In recent decades, medical researchers have investigated marijuana's effects on various kinds of pain -- from damaged nerves in people with HIV, diabetes and spinal cord injury; from cancer; and from multiple sclerosis. Marijuana has also been hypothesized to help with nausea induced by chemotherapy and antiretroviral therapy, and with severe loss of appetite as seen in people with the AIDS wasting syndrome.

The weed's actions are due to the active ingredients tetrahydrocannabinol (THC) and some 60 other cannabinoids, which mimic the action of chemicals -- known as endogenous cannabinoids -- that exist naturally in the brain. Those cannabinoids activate receptors in our nerves, triggering physiological responses.

A legal prescription form of THC (Marinol) exists, yet researchers say it's far from a perfect drug. Taken orally, its absorption is highly variable and unpredictable and often delayed, says Dr. Igor Grant, a UC San Diego psychiatrist who directs the university's Center for Medicinal Cannabis Research. "Smoking is a very efficient way to deliver THC," he says.

As a result of its federally illegal status, medicinal use of marijuana is restricted to carefully vetted clinical research studies or to patients in states such as California that have passed laws to allow for personal medical use. Research on the medicinal use of marijuana relies on government-issued marijuana cigarettes, which come in different strengths and are supplied by the National Institute on Drug Abuse.

The UC Center for Medicinal Cannabis Research in San Diego helps coordinate clinical studies to investigate the safety and effectiveness of marijuana. Here's what they've found.

Neuropathic pain

Recent research suggests that marijuana can assuage this chronic-pain syndrome in which burning sensations occur and simple touch can feel like hurt. It is unaffected by aspirin-like drugs and fairly resistant to stronger analgesics such as opiates.

In a 2007 study on neuropathic pain related to HIV infection, 50 patients smoked marijuana cigarettes three times a day or marijuana cigarettes from which active ingredients had been extracted. Subjects then rated their pain on a scale ranging from "no pain" to "worst pain imaginable." The results, published in the journal Neurology, showed a 34% reduction in ratings of pain in the marijuana group compared with 17% in the placebo group over five days of treatment.

Another study in 44 patients reported in June in the Journal of Pain found that marijuana alleviated neuropathic pain arising from a variety of conditions, including spinal-cord injury and diabetes. Participants smoked marijuana on a set schedule -- first two puffs, then three puffs an hour later, then four puffs an hour after that -- from a single cigarette containing either 0%, 3.5%, or 7% THC. Average pain ratings before smoking were 55 on a 100-point scale and decreased by 46% in both treatment groups and by 27% in the placebo group one hour after the last puff.

Analgesic drugs are often tested against experimentally induced pain. Such studies have been conducted for marijuana too. In one 2007 report in the journal Anesthesiology, 15 healthy volunteers received skin injections with capsaicin -- the chemical behind that fiery spice in chile peppers -- and then smoked different-strength marijuana cigarettes. The medium dose, with a 4% THC concentration, lessened the burning pain.

These three pain studies all concluded that smoked marijuana can bring relief to sufferers of neuropathic pain comparable to other analgesic drugs. It is not a cure, Grant says: "It's like other pain medicines, you have to keep taking it."

Study subjects did feel high, an effect that varied among individuals. Marijuana also affected thinking, shown as problems with tasks of memory and complicated reasoning after the strongest marijuana cigarettes were used. Potentially problematic, these effects were tolerated by subjects -- no one opted out of the study because they couldn't think straight.

Grant says it's important to have a choice of treatments because not everyone responds to or can tolerate the available drugs. Antidepressants are used for neuropathic pain but cause dry mouth, constipation and urinary problems, and must be avoided by people with conditions such as glaucoma. Others can't take aspirin-like drugs. "Having an alternative compound is always good," Grant says.

Multiple sclerosis

Patients with multiple sclerosis suffer muscle spasms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1658), pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=752) and tremor (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1728). Anecdotal reports suggest that marijuana may be helpful, but controlled studies are few. One, presented at an April meeting, had 51 multiple sclerosis patients smoke 0% or 4% THC marijuana cigarettes daily for three days. Intensity of spasms was reduced by 32% and pain ratings by 50% after smoking marijuana, compared with 2% and 22% reductions after placebo cigarettes. Five subjects withdrew, citing side effects: feeling too high, dizzy or fatigued.

Other studies in patients with multiple sclerosis used a cannabis extract that can be taken orally. In a 2007 European Journal of Neurology study, nearly half of 184 patients experienced at least 30% improvement in muscle spasms.

But a 2004 Neurology paper showed no reduction in objective measures of arm tremor with cannabis extract, although five subjects out of 13 reported feeling improvement. This might have resulted from mood-altering effects of the drug or from some aspect of tremor not measured.

Nausea

A 2008 review published in the European Journal of Cancer Care analyzed 30 clinical studies using cannabinoid drugs synthesized in the lab and concluded that they were better than standard antinausea drugs in alleviating the nausea and vomiting that accompanies chemotherapy. One such drug is Marinol, a THC preparation approved by the Food and Drug Administration for precisely this purpose.

Survey studies suggest that some people with HIV smoke marijuana to counteract nausea caused by antiretroviral therapy. Researchers at the UC Center for Medicinal Cannabis Research have tried to study the effect of smoked marijuana on nausea and vomiting in patients undergoing chemotherapy but have struggled to enroll enough subjects, Grant says.

Bruce Mirken, director of communications for the Marijuana Policy Project -- a group that lobbies for the decriminalization of marijuana -- says he is all for research on the chemical components in marijuana with the goal of making more-purified and perhaps more-targeted drugs that do not deliver a "high," but does not see "criminalizing use of that plant by people who are ill when you are making its main psychoactive ingredient legal in the form of a very expensive pill."

Tom Riley, a spokesman for the White House Office of National Drug Control Policy, says marijuana advocates are seeking a free pass. "They want to be exempted from the regular [drug] approval process," he says.
Source: Los Angeles Times Copyright 2008 Los Angeles Times (19/08/08)

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National MS Society makes recommendations regarding therapeutic use of Cannabis 05 August 2008 http://www.msrc.co.uk/images/gallery/img_cannabis.jpg
Cannabis has the potential to treat symptoms of multiple sclerosis as well as limit the progression of the disease, according to an expert opinion paper published by the US National Multiple Sclerosis Society. However, the Society stopped short of recommending that MS patients use the drug medicinally.
“Although it is clear that cannabinoids have potential both for the management of MS symptoms such as pain and spasticity, as well as for neuroprotection, the Society cannot at this time recommend that medical marijuana be made widely available to people with MS for symptom management,” the Society concludes. “This situation might change, should better data become available that clearly demonstrate benefit.”
The Society recommends that future clinical trials focus on methods of cannabinoid administration that deliver the drug to the bloodstream rapidly, such as vapourization.

The Society also recommends clinical trials be performed to investigate and quantify cannabis’ potential to slow disease progression, citing “anecdotal reports from patients … that cannabis reduces the frequency of their MS attacks.”

Investigators at Plymouth’s Peninsula Medical School in Britain recently announced that they had recruited nearly 500 MS patients for a three-year clinical trial assessing whether the use of oral THC can significantly slow the onset of multiple sclerosis.

Clinical data reported in 2006 from an extended open-label study of 167 multiple sclerosis patients found that the use of whole plant cannabinoid extracts relieved symptoms of pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=752), spasticity (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1658), and bladder incontinence (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=751) for an extended period of treatment (mean duration of study participants was 434 days) without requiring subjects to increase their dose.

Results from a separate two-year open label extension trial in 2007 also reported that the administration of cannabis extracts was associated with long-term reductions in neuropathic pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1740) in select MS patients. On average, patients in the study required fewer daily doses of the drug and reported lower median pain scores the longer they took it.

Commenting on the MS Society report, NORML Deputy Director Paul Armentano said: “The MS Society’s recommendations are a positive step, but they don’t go far enough. Surveys indicate that as many as one out of two MS patients use cannabis therapeutically, yet this report does nothing to challenge these patients legal status as criminals.”
Source: PR.Cannazine.co.uk (05/08/08)

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Milestone for cannabinoid Multiple Sclerosis study 21 July 2008 The CUPID (Cannabinoid Use in Progressive Inflammatory brain Disease) study at the Peninsula Medical School has reached an important milestone with the news that the full cohort of 493 patients with multiple sclerosis (MS) has been recruited to the programme. CUPID is a clinical trial part-funded by the MS Society, which will evaluate whether tetrahydrocannabinol (THC) - the main active ingredient in the cannabis plant and one of many compounds found in the organism - is able to slow the progression of MS.
It is an important study for people with MS, because current treatments either target the immune system in the early stages of MS, or ease specific symptoms such as muscle spasms or bladder problems.
The CUPID trial follows an earlier study - Cannabinoids and Multiple Sclerosis (CAMS) - which established a link between THC and the slowing of MS. The CAMS trial saw participants take THC for a year - the CUPID trial will last for longer and aims to assess the affect of THC on progressive (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=742) MS.
It has taken two years to recruit the 493 patients, and they will take part in the trial for three years; in some cases three and a half years. After data cleaning and analysis the results should be available by spring/early summer 2012.
Dr Laura Bell, research communications officer for the MS Society, said: "People affected by MS are keen to know whether there's any truth in the suggestion that elements of the cannabis plant can help ease the symptoms and slow down progression of the condition.
"The MS Society is supportive of safe clinical trials investigating the medicinal properties of cannabis and it's great news that this trial is going ahead. We look forward to the results of this exciting study."
Professor John Zajicek from the Peninsula Medical School, who heads the team carrying out the CUPID study, said: "We are delighted to have achieved the correct number of patient participants for this trial. Patients have been recruited from 27 sites across the UK.
"If we are able to prove beyond reasonable doubt the link between THC and the slowing down of progressive MS, we will be able to develop an effective therapy for the many thousands of MS sufferers around the world."
Helen Yates, MSRC Chief Executive, said "MSRC is delighted that the full quota of participants has been reached for this trial. People affected by MS are keen to find out if the effects of THC extend beyond symptom (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743) management and into the area of slowing the progression of the disease.

We look forward to the results in 2012."
The CUPID trial is jointly funded by the MS Society, the Multiple Sclerosis Trust and the Medical Research Council.
Source: PR Newswire Europe Ltd. (21/07/08)

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Multiple sclerosis and cannabis - a cognitive and psychiatric study 15 July 2008 Background: A significant minority of patients with multiple sclerosis (MS) use cannabis, yet no study has examined the possible effects on mentation. Here, we report the emotional and cognitive correlates of street cannabis use in patients with MS. Methods: A sample of 140 consecutive patients with MS were interviewed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorders (SCID-IV) from which details of cannabis use were recorded. Cognition was assessed using the Neuropsychological Battery for MS supplemented with the Symbol Digit Modalities Test (SDMT), an index of information processing speed, working memory, and sustained attention.
Results: Ten subjects (7.7%) were defined as current cannabis users based on use within the last month. Compared to non-cannabis users (n = 130), they were younger (p = 0.001). Each of the 10 current cannabis users was matched on demographic and disease variables to four subjects with MS who did not use cannabis (total control sample n = 40). Group comparisons revealed that the proportion of patients meeting DSM-IV criteria for a psychiatric diagnosis was higher in cannabis users (p = 0.04). In addition, on the SDMT, cannabis users had a slower mean performance time (p = 0.006) and a different pattern of response compared to matched controls (group x time interaction; p = 0.001).
Conclusions: Inhaled cannabis is associated with impaired mentation in patients with multiple sclerosis, particularly with respect to cognition. Future studies are required to clarify the direction of this relationship.
Omar Ghaffar, MD, FRCP(C) and Anthony Feinstein, MPhil, PhD, FRCP(C)
From the Neuropsychiatry Program, Department of Psychiatry, Sunnybrook Health Sciences Centre and University of Toronto, Canada.
Source: Neurology © 2008 by AAN Enterprises, Inc. (15/07/08)

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The endocannabinoid system is dysregulated in multiple sclerosis and in experimental autoimmune encephalomyelitis 27 September 2007 The ability of cannabinoids to modulate both inflammatory and degenerative neuronal damage prompted investigations on the potential benefits of such compounds in multiple sclerosis (MS) and in animal models of this disorder. Here we measured endocannabinoid levels, metabolism and binding, and physiological activities in 26 patients with MS (17 females, aged 19–43 years), 25 healthy controls and in mice with experimental autoimmune encephalomyelitis (EAE), a preclinical model of MS.
Our results show that MS and EAE are associated with significant alterations of the endocannabinoid system. We found that anandamide (AEA), but not 2-arachidonoylglycerol (2-AG), was increased in the CSF of relapsing MS patients. AEA concentrations were also higher in peripheral lymphocytes of these patients, an effect associated with increased synthesis and reduced degradation of this endocannabinoid. Increased synthesis, reduced degradation, and increased levels of AEA were also detected in the brains of EAE mice in the acute phase of the disease, possibly accounting for its anti-excitotoxic action in this disorder.
Accordingly, neurophysiological recordings from single neurons confirmed that excitatory transmission in EAE slices is inhibited by CB1 receptor activation, while inhibitory transmission is not.
Our study suggests that targeting the endocannabinoid system might be useful for the treatment of MS.
Source: Brain Copyright © 2007 Guarantors of Brain (27/09/07)

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Cannabis could hold the key to ending multiple sclerosis misery 03 April 2007 Researchers investigating the role of cannabinoids - chemical substances contained within cannabis – in the treatment of multiple sclerosis (MS), have found they could significantly enhance therapy, not only by reducing nerve damage and erratic nerve impulses, but perhaps even by hindering development of the condition. The findings, published online in Nature Medicine demonstrates for the first time how cannabis might actually slow down the progression of MS and could have major implications for the estimated 2.5 million patients worldwide.
Using a mouse model, a team of UK, European, Japanese and US scientists, led by David Baker, Professor of Neuroimmunology at Queen Mary, University of London, found that doses of the active component within cannabis, tetrahydrocannabinol (THC) could significantly inhibit the development and severity of MS.
Cannabis works because it stimulates molecules known as cannabinoid receptors within the body. The group had previously reported that THC could alleviate disease symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743), and also save nerves from the damaging effects of the disease - thus potentially, via the cannabinoid receptor CB1, slowing down the development of progressive disability. They had not previously examined the influence of cannabinoids on immune aspects of the disease.
Now their most recent study has successfully separated the roles of cannabinoid receptors CB1 and CB2 on neurons and T cells, and investigated their effect in controlling central nervous system autoimmunity. It showed that CB1 receptor expression by nerves in the brain, but not T cells, could suppress the development of an experimental MS-like disease, by stimulating the release of anti-inflammatory molecules, whilst in contrast direct stimulation of CB2 receptors by T cells was also able to control inflammation associated with the condition. This suggests that cannabis-like drugs may have the potential to block the autoimmune response which drives disease development.
Professor David Baker said: “Whilst targeting CB1 receptors for therapy runs the risk of causing the unwanted “high” to achieve these effects, we can get the same result by targeting CB2 receptors, which avoids these risks. Therefore, we can start to think about using new drugs that harness the potential medical benefits that cannabis has to offer but move away from the issues over the legality and recreational use of the plant product”.
Source: Queen Mary, University of London

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Cannabis effects on MS trialled 12 February 2007 Patients are being recruited for a trial to determine whether chemicals in cannabis can slow the impact of multiple sclerosis. Evidence suggests the drug may relieve symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743) but the three-year national trial is also to determine whether it slows the disease's progress.
It is estimated that 85,000 people in the UK have multiple sclerosis (MS).
Prof John Zajicek, of the Peninsula Medical School and Derriford Hospital in Plymouth, will lead the research.
One component of cannabis, called THC, is now being tested in a trial, funded by a £2m grant from the Medical Research Council, along with charities the MS Society and MS Trust.
"This trial will build on our previous study which, coupled with our work in the laboratory, suggested that THC could have a protective effect on nerves," said Prof Zajicek.
"Multiple Sclerosis is a very unpredictable disease. Currently there are few medicines which are effective in treating MS and none have been shown to have any effect in the progressive stages (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=742) of the disease."
MS is caused when the patient's own body damages the protective covering of the nerves - affecting signals from the brain.
Progressive MS is thought to be caused by damage to the nerves themselves.
'Far-reaching implications'
"If this study demonstrates that cannaboids do have a longer term effect on the progression of disability, there are potentially far-reaching implications, not only for the health of people with MS, but also for those with other neurodegenerative conditions."
Prof Zajicek is trying to recruit 500 patients with progressive MS through 30 centres across the UK.
The research follows on from a previous trial carried out by the same team, which focused on testing the benefit of cannabis derivatives over a 15-week and 12-month period.
Derivatives of cannabis are known as cannaboids.
The study is taking place in collaboration with Professor Alan Thompson at the National Hospital for Neurology and Neurosurgery (part of University College London Hospitals NHS Foundation Trust) and Institute of Neurology, University College London.
Potential patients interested in taking part in the study should call 0800 0153430, or e-mail: cupid@pms.ac.uk (cupid@pms.ac.uk)
Source: BBC Health Copywrite BBC 2006

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Cannabis truly helps multiple sclerosis patients 12 February 2007 Cannabis may loosen the stiff and spastic muscles of multiple sclerosis patients, and not just their minds, a follow-up study has found. The results contradict findings from the first phase of the study, where improvements seemed to be largely due to "good moods".
“There does seem to be evidence of some benefit from cannabis in the longer term that we didn’t anticipate in the short term study,” says John Zajicek, at Peninsula Medical School in Exeter, UK, and one of the research team.
In 2003, Zajicek and his colleagues published results (http://www.newscientist.com/news/news.jsp?id=ns99994356) on the largest study to date of cannabinoids and MS. The trial included 630 advanced-stage MS patients who took either cannabinoid compounds or a placebo for 15 weeks.
Compared with those on placebos, patients who received active compounds said they both felt less pain and less muscle spasticity – the spasms characteristic of this neurodegenerative disease.
Good guess
But physiotherapists using standard evaluations were unable to corroborate the patients' claims of improved mobility or muscle stiffness.
The results were further complicated because about two thirds of the patients who received cannabis compounds, such as D9-tetrahydrocannabinol (THC), guessed they had not received a placebo, due to the drugs effect on their mind.
The knowledge that they were receiving an active compound, along with the mood-altering effects of THC, may have explained why subjects reported improvements.
“If you’ve got a drug that elevates mood and makes people feel better, how can you be sure that it’s really affecting their underlying disease and their symptoms?” asks Zajicek.
Marked improvement
When the short-term study ended, however, the researchers gave all subjects the opportunity to continue their treatment for a full year. The team wanted to extend the study to gather information on the safety of long-term cannabinoid use.
More than 500 patients agreed to stay on their original treatment. One group took pills of D9-tetrahydrocannabinol (THC), the active ingredient in cannabis. The second group received natural cannabis extract, and the third group took a placebo.
At the end of the 12 month period, the patients were evaluated again using the same measures as in the first study. But this time, physiotherapists saw a marked improvement for subjects on active drugs. They had reduced muscle spasticity and an improved overall score for their level of disability.
Zajicek is cautious about the implications of the study as it was not specifically designed to test the efficacy of drugs over 12 months. But the results do support animal research that shows cannabinoids may slow nerve cell death and protect against damage.
The findings were presented at the British Association for the Advancement of Science Festival, in Exeter, UK
Source: NewScientist.com news service © Copyright Reed Business Information Ltd. (10/09/04)

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Brain's own cannabis compound protects against inflammation 12 February 2007 Some clinical studies have indicated that marijuana or its active cannabinoid ingredient alleviates symptoms of the inflammatory disease multiple sclerosis (MS). Also, researchers have found that the brain's natural "endocannabinoids" are released after brain injury and are believed to alleviate neuronal damage. However, scientists have not understood how such substances act within the brain's own immune system. Now, experiments by Oliver Ullrich and colleagues have pinpointed how one of the brain's endocannabinoids protects neurons from inflammation after such damage. They say their studies could lead to new drugs to treat the inflammation and brain degeneration from MS or other such disorders.
In an article in the January 5, 2006, issue of Neuron, the researchers reported experiments showing how the endocannabinoid anandamide (AEA) protects brain cells from inflammation. Such a role in the brain's immune system is distinct from cannabinoids' effects on neuronal signaling that produce the behavioral effects of marijuana.
When Ullrich and colleagues analyzed brain tissue from people with MS, they found elevated levels of AEA, compared to healthy tissue. And in studies with mouse brain slices, they found that inducing damage with a brain-cell-exciting chemical, called NMDA, caused an invasion of the brain's immune cells, called microglia, and an increase in AEA levels.
Importantly, they found that adding AEA to such damaged brain tissue abolished inflammatory damage to the brain cells, but did not reduce the primary "excitotoxic" damage from the chemical. They found similar effects of AEA when they damaged the brain tissue by depriving it of oxygen and glucose.
The researchers also found that when they used a drug to block the receptors on microglial cells by which AEA effects the cells, inflammatory damage was increased.
The researchers also explored the mechanism by which AEA prevents inflammatory damage. They found that, when AEA plugs into its receptors on activated microglial cells, it basically activates a specific molecular signaling pathway that suppresses the production of inflammation-causing nitric oxide, which would otherwise cause brain injury.
The researchers concluded that the release of AEA in injured brain tissue might act as a "gatekeeper" and an important "negative-feedback loop within the CNS [central nervous system] immune system needed to reduce the extent of the inflammatory response and to limit neurodegenerative immune reactions after primary brain damage.
"Moreover, endocannabinoid signaling strongly suppresses attack of microglial cells on nondamaged neurons," they wrote, "suggesting also a physiological function of the endocannabinoid system in maintaining a protective and healthy CNS microenvironment."
They also concluded that "the endocannabinoid system represents a local messenger system between the nervous and immune system and is obviously involved in the control of immune activation and neuroprotection. Therefore, elucidating the pathology of the endocannabinoid system during neuroinflammation and neurodegeneration might open new avenues of therapeutic interventions in the future."
The researchers included Eva Eljaschewitsch, Christian Mawrin, Peter M. Schmidt, Regine Schneider-Stock and Oliver Ullrich of the Otto-von-Guericke-University Magdeburg in Magdeburg, Germany; Anke Witting of the University of Washington in Seattle, WA; Thomas Lee, Heide Hoertnagl and Robert Nitsch of the Charité University Hospital Berlin in Berlin, Germany; Susanne Wolf of the Max-Delbrueck-Center of Molecular Medicine in Berlin, Germany; Cedric S. Raine of the Albert Einstein College of Medicine in New York, NY. This work was supported by the Research Network N2 of the State Saxony-Anhalt of Germany (O.U.) and a grant from the Deutsche Forschungsgemeinschaft to R.N., O.U., and R.S.S. and National Institutes of Health grants (NS 08952 and NS 11920) to C.S.R.
Source: Eljaschewitsch et al.: "The Endogenous Cannabinoid Anandamide (AEA) Protects Neurons during CNS Inflammation by Induction of MKP-1 in Microglial Cells." Publishing in Neuron 49, 67–79, DOI 10.1016/j.neuron.2005.11.027 (05/01/06)

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Cannabis has medical benefits but needs further investigation, says report 12 February 2007 Medicines based on cannabis and its derivatives have the potential to treat a range of symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743) but need to be developed with the same care and regulation as other new drugs, says a report from the Royal College of Physicians.
The report calls for more research into cannabis based medicines for a variety of clinical situations, including appetite loss, chronic pain, and multiple sclerosis. It acknowledges also that cannabis-like substances may have a role in managing obesity, heart disease, and osteoporosis and in helping people quit smoking. Clinical trials in these areas are warranted, it concludes.
Some of the strongest evidence for the therapeutic potential of cannabis and its derivatives comes from research into multiple sclerosis. The report describes “convincing evidence” from animal models that cannabis can reduce spasticity and tremor and slow down the course of the disease. However, few randomised controlled trials have been carried out in humans, and longer studies are needed to provide clear evidence of the benefits in people, particularly on the progression of symptoms.
The report, which examined the evidence relating to the medicinal uses of cannabis and its active ingredients, such as tetrahydrocannabinol, says that smoking cannabis should be avoided, as this carries similar risks to the lungs as smoking tobacco. Alternative methods of administration should be studied, including capsules and mouth sprays.
Although concerns have been voiced about the development of dependence among people who use cannabis in trials, this has not been found to be a problem, says the report. Similarly, people who have been allowed to adjust the dose of tetrahydrocannabinol according to their symptoms have not found potential side effects—such as dizziness, reduced attention, and gastrointestinal symptoms—to be troublesome.
Another major concern that has become evident from the recreational use of cannabis is the risk of psychoses, especially among young people. Young age and previous psychotic episodes should be relative contraindications to the use of cannabis-based medicines, the report concludes. It recognises, however, that the people most likely to receive such medicines will be older.
Martin Wilkins, chairman of the working party and professor of clinical pharmacology at Imperial College London, said: “Cannabis-based medicines are an active area of research and may offer new treatments for the symptoms of multiple sclerosis, pain, cardiovascular disease, and osteoporosis. It is appropriate that these medicines are examined and developed through carefully controlled clinical trials, in line with the regulations governing the approval of new drugs.” Cannabis and Cannabis-based Medicines: Potential Benefits and Risks for Health is at www.rcplondon.ac.uk/pubs/books/cannabis (http://www.rcplondon.ac.uk/pubs/books/cannabis)
Source: BMJ.com © 2005 BMJ Publishing Group Ltd (17/12/05)

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Marijuana derivatives may provide MS treatment 12 February 2007 Marijuana derivatives or "cannabinoids" taken for one year for the treatment of multiple sclerosis (MS) may reduce muscle spasms and other aspects of disability, results of a UK study suggest.
Dr. J. P. Zajicek, from Peninsula Medical School in Plymouth and colleagues previously reported that cannabinoids taken for 14 weeks appeared to improve mobility and patients' perception of their MS symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743). In an extension study, 80 percent of subjects agreed to continue on the medication for up to 52 weeks. The results are reported in the Journal of Neurology, Neurosurgery and Psychiatry.
The analysis included more than 500 patients who were randomly assigned to receive various cannabinoids or an inactive "placebo."
Treatment with delta-9-THC, a synthetic cannabinoid, seemed to relieve muscle spasms. In addition, patients treated with this drug and other cannabinoids reported improvements in sleep and pain.
Zajicek's group concludes that "there is now an urgent need to construct a long-term study in progressive (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=742)MS to establish whether delta-9-THC has a role in long-term disease."
Dr. J. Killestein and Dr. B. M. J. Uitdehaag, writing in a related editorial, agree with Zajicek's team about the need for more long-term trials.
The editorialists, from VU Medical Center in Amsterdam, the Netherlands, add that "these trials should also focus on different cannabinoid products."
SOURCE: Journal of Neurology, Neurosurgery and Psychiatry, (01/12/05)

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Cannabinoids Inhibit Degeneration 12 February 2007 Scientists in London have found that cannabinoids have a neuroprotective effect in the animal model of MS, EAE.
Dr Price and colleagues at the Institute of Neurology found that mice which were deficient in the cannabinoid receptor CB1 tolerate inflammatory and excito toxic insults poorly and develop substantial neurodegeneration following immune attack in EAE.
They suggest that, in addition to symptom management, cannabis may also slow the neurodegenerative processes that ultimately lead to chronic disability in Multiple Sclerosis .
Pryce G, Ahmed Z, Hankey DJ, Jackson Si, Croxford JL, Pocock JM, Ledent C, Petzold A, Thompson AJ, Giovannoni G, Cuzner ML, Baker D. Department of Neuroinflammation, Institute of Neurology, University College London, London, UK
Source: Brain (22/07/03)

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MS Cannabis trial at Ipswich General Hospital 12 February 2007 A consultant at Ipswich Hospital is involved in groundbreaking new trials to see if cannabis really does relieve thesymptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743)of Multiple Sclerosis .
Trials are being conducted nationally by the Medical Research Council into the use of cannabis as a prescribed drug.
Multiple Sclerosis patients have been campaigning for several years for the trials and some have even been taken to court for using the drug which they claim relieves the debilitating symptoms they have.
But MS patient, Stephen Williams, of St Peters Road, Stowmarket, treated the news with some caution. He was diagnosed 16 years ago and said during that time his hopes had been raised too often only to be dashed when the treatment proved too expensive. The 52-year-old said, "The frustrating thing is being told that there is a major breakthrough but it has to go through five years of trials. So you sit and wait patiently and then you find you can't have it after all because it is too expensive."
Mr Williams has been closely following tests of cannabis and spoke out in the Evening Star in September for the cannabis law to be reformed so he could use it to relieve the pain wracking his body.
He said, "I have been checking the website of a pharmaceutical company (which is running trials) and they said that in most incidences they have had good results. Although there are still a lot of people that it does not help, it is helping more than they thought. When I was first diagnosed in 1986 the doctors told me not to worry and that there would be a cure by the end of the century that has been and gone. I am wary of it but now it is in Ipswich I will ask my GP if I can get involved."
Bob Wake from Stradbroke, near Eye, was diagnosed with MS 14 years ago. At that time he said he never believed medical research would advance this far.
He said, "I never thought I would see this. We always hoped that it would and various things have come up during that time. When I was diagnosed I did not think there would be anything for me and cannabis may not be the one but at least we can try."
Mr Wake, 67, is involved in the East Anglian Branch of the Multiple Sclerosis Society and often gives talks to both MS patients and non-patients.
He said, "From what I know, cannabis does not seem to be doing much harm. If you have MS you are willing to have a go at absolutely anything you don't know when you wake up each morning which part of you is never going to work again. When I have been to meetings and talked to people, they have said that as long as there would not be any terrible side effects they would try anything even if there was only a one in a thousand chance it would work. No two patients are the same and MS affects random sections of the brain. One person could be helped in a different way to another."
Dr Stephen Wroe is a consultant neurologist at Ipswich Hospital and he has been involved in the trials. He was unavailable to comment today but it is believed that around 23 patients are actually taking part. If the trials are successful the treatment could be in place as early as 2004.
For further information, refer to the Media Awareness Project article (http://www.mapinc.org/norml/v02/n1232/a09.htm?134). (04/07/02)

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Cannabis trial launched in patients with MS 12 February 2007 The world’s biggest clinical trial of the cannabis plant got under way this week at Derriford Hospital, Plymouth; the trial is looking at the control of pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=752) and tremors in Multiple Sclerosis . Twenty patients were given their first doses of capsules containing cannabis oil, tetra hydro cannabinol, or placebo. After three months, if all goes to plan, the trial will be slowly extended across the country, eventually taking in 660 participants in 40 centres.
The cannabis in Multiple Sclerosis (CAMS) study is sponsored by the Medical Research Council and approved by the government, which has arranged for the drug to be imported from Switzerland. A parallel study will examine the effect of the drug on lower urinary tract symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=751).
Patients will undergo up to five weeks of titration, followed by two months at a steady dose."We’re looking for a dose that can help relieve symptoms with minimal side effects," said research registrar Dr Patrick Fox. "We find that few patients want to be stoned or high when they have to take the drug all the time."
Patients who benefit from the treatment can opt to continue for a further nine months. They may legally take their medication home because each has been granted a licence by the Home Office to possess schedule 1 drugs. Participants have been advised not to drive during the study period.
Cannabis has been a schedule 1 drug since 1971, when the World Health Organization pronounced it medically useless. Two years ago a House of Lords select committee argued that more research was necessary in view of widespread anecdotal reports of the drug’s efficacy in controlling pain and tremor, particularly in Multiple Sclerosis .
The government has announced its willingness to amend drug laws if the benefits of cannabis can be shown. This would mean giving cannabis a legal status similar to morphine.
The CAMS study is the fourth cannabis trial to begin in Britain in recent months. Three smaller phase II trials have been under way since the autumn—in Guernsey, Oxford, and Norfolk. The drug used in these trials is a sublingual spray, taken from plants grown by G W Pharmaceuticals in Kent. The researchers expect to extend these trials to 2000 patients over the next two years.
Professor William Notcutt, who heads the trial at the James Paget Hospital, Gorleston, Norfolk, has enrolled not only people with Multiple Sclerosis but also patients with various chronic pain syndromes, such as neuralgia and lower back pain. "We’re looking at overall quality of life as well as pain relief," he said. "If a patient says they feel better since starting the drug, I’m not going to panic that some of that might be drug induced euphoria and cut their dose on moral grounds."
For further information, refer to the 'BMJ general medical journal' article (http://bmj.com/cgi/content/full/322/7280/192/c). (27/01/01)

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Cannabis derivative drugs may be made available to MS patients 12 February 2007 The government is clearing the way for the introduction of cannabis derivatives as NHS medicines to treat Multiple Sclerosis and relieve pain after operations if trials of two drugs prove successful. The Department of Health is to ask the National Institute For Clinical Excellence (NICE) to begin assessing next year whether the treatments are effective and worth the money they might cost the NHS. Ministers will today announce consultations on the scheme.
The painkillers might be available on prescription in 2004 or 2005 if the process of trials, licensing and NHS approval is completed on time.
One drug, cannabis-based medicinal extract, is an under-the-tongue spray being tested by GW Pharmaceuticals; the other is a tablet called Dronabinol, manufactured by Solvay Healthcare. Neither is expected to give the 'high' enjoyed by cannabis smokers.
There have been anecdotal claims for years that smoking, infusing or eating cannabis can alleviate symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743)of MS including spasm (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1658), incontinence (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=751) and pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=752).
The new drugs may also help treat nausea, leading to speculation that cannabis derivatives could provide treatments for a wider range of medical conditions.
The health analyses are being undertaken at the same time as a wider debate within government and police forces over the criminal uses of dope.
The home secretary, David Blunkett, is downgrading cannabis from a Class B to a Class C drug. While it still carries a possible two-year jail penalty for possession, a softly softly approach to its use has been controversially piloted in Lambeth, south London.
There are thought to be about 85,000 people in Britain with MS, a disabling disease of the nervous system.
David Harrison, spokesman for the Multiple Sclerosis Society, said yesterday: "If we are in a situation where we are going to have drugs approved which look as if they have a significant effect on helping alleviate symptoms, and it has been shown they can be safely used, we would want people to have access to them as soon as possible."
But he issued a note of caution about the anecdotal evidence. "We know a lot of people who say 'cannabis is wonderful; nothing else does this job for me'. You hear less about those who try it and get horrible reactions.
"We have always said people who are using it for medicinal purposes should be treated sympathetically."
The drugs which are being tested will need to be licensed by the government's medicines control agency. But there has been criticism that NICE, which must then decide whether the NHS should support the use of the drugs, holds up the process for making drugs available after that stage.
Running its assessment in parallel to the licensing procedure for the cannabis drugs should lead to such "NICE-blight" being avoided.
The NICE assessments will begin in April 2003 after some drugs trial results are available. Consultation on what should be in next year's programme starts today. Treatments for dementia, hepatitis C and leg ulcers are among others proposed by the health department. Nice decisions only directly affect the NHS in England and Wales but it is unlikely Scottish or Northern Ireland health authorities would refuse to back the cannabis drugs if they were supported elsewhere.
For further information, refer to the Guardian article (http://www.guardian.co.uk/medicine/story/0,11381,652117,00.html). (18/02/02)

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Sativex approved for Multiple Sclerosis in Canada
http://www.msrc.co.uk/images/gallery/img_sativex.jpg
GW Pharmaceuticals has become the first drug company to gain approval to launch a cannabis-based medicine for multiple sclerosis sufferers.
The approval in Canada comes after six years of work for the company, which grows cannabis at a secret farm in southern England and turns it into an under-the-tongue spray, Sativex (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1814). And it marks a breakthrough for MS sufferers, who have long argued that cannabis relieves its symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743), including pain and spasticity.
The Canadian authorities will allow GW, through its marketing partner, the German drug giant Bayer, to sell Sativex as a prescription painkiller, provided the company does additional clinical trials of the medicine over the next five years. GW must confirm the results of the studies to date, which have been promising, Health Canada said. The drug has so far been turned down by regulators in the UK, who say GW has not proven to their satisfaction that Sativex is effective.
Bayer will pay GW a £2m milestone as a result of Health Canada's approval.
Launch batches of Sativex are already in the country, and the drug will be available within weeks. Analysts disagree on the likely sales potential in Canada, which has 50,000 MS sufferers, half of whom suffer from the neuropathic pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1740) Sativex has been approved to treat. Smoked cannabis is also available in Canada for medicinal use, and proposals for its decriminalisation are being debated.
Karl Keegan, an analyst at Canaccord, said: 'I think initially there will be a lot of hype over Sativex, but I suspect that people will want to smoke cannabis rather than use a mouth spray.'
How Sativex is seen
Canada: Health Canada has become the first regulator to approve a prescription medicine based on cannabis. Because so few MS sufferers say their pain can be treated effectively with existing medicines, it accelerated the approval process.
UK: GW has faced several setbacks in its dealings with the UK, despite the Home Office's backing for its plans to develop a cannabis-based MS treatment. The independent medicines regulator argued there was not enough data to support its launch as a painkiller. GW is appealing the ruling at a hearing.
Europe: European regulators will take their cue from the UK, so analysts believe that Sativex's full commercial potential can only be unlocked when GW has satisfied the regulator in its home country.
US: Originally thought opposed to cannabis-based medicines because it would represent weakness in its war on drugs. Now, though, GW believes regulators might be won round and will open talks this summer on how it might be allowed to trial Sativex in the US.
Source: NowPublic © NowPublic Technologies Inc. (14/10/08)

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Sativex spray considered for Multiple Sclerosis in New Zealand
http://www.msrc.co.uk/images/gallery/img_cannabis.jpgCannabis products could soon be used legally for medical purposes in New Zealand, after an application by a leading drug company to market a liquid version for pain relief.
Medsafe is considering whether to allow the marketing and sale of cannabis spray, Sativex (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1814), after an application from its British maker.
It comes as the Government faces increasing pressure from some patients and scientists to legalise cannabis use to alleviate chronic pain for accident victims and some sufferers of multiple sclerosis and cancer.
Cannabis is a class C drug and cannabis preparations are class B drugs, but the Medicines Act allows the drug to be used with ministerial approval.
The Health Ministry said approval to use Sativex had been granted for three patients, and a further application was pending.
The spray, which is administered under the tongue, was developed by British firm GW Pharmaceuticals for multiple sclerosis patients and has been legal in Canada since 2005.
Rose Wall, the ministry's quality and safety manager, said the Medsafe application to market Sativex as a medicine was still being considered.
In a briefing paper to former health minister Pete Hodgson, issued by the ministry last year, officials said there was "sufficient evidence of safety and efficacy of cannabis in some medical conditions" to support consideration of compassionate, controlled use.
A group of medicinal cannabis users presented a petition with 3000 signatures to the health select committee in July, urging law reform for medical purposes.
Billy McKee, who appeared before the committee and is the director of GreenCross, a patients' medicinal cannabis support group, said patients who used cannabis medicinally faced many risks in buying it on the black market.
He smoked cannabis to control chronic nerve pain dating from car crash injuries sustained 15 years ago and would welcome Sativex if he could "easily access and afford it".
But he believed users could face costs of $150 to $300 weekly as it was not subsidised by Pharmac.
Mr McKee said users faced obstacles growing the drug, including arrest. His home had been burgled 20 times by thieves trying to remove plants.
Multiple Sclerosis Society national director Graham Billings said the agency supported the use of Sativex in New Zealand. "But until it's been made legal we can't really comment."
Otago University Pharmacology professor Paul Smith said the drug, which contained two cannabis strands - THC and cannabidiol - would not work for all chronic pain sufferers but initial results in multiple sclerosis patients showed about 30 per cent success, including reducing symptoms in some patients.
He believed the evidence was compelling and the drug should be allowed as, unlike cannabis plant and oil, it did not have to be smoked.
"The fact that it happens to be cannabis, from a pharmacologist point of view, is irrelevant."
GW Pharmaceuticals could not be contacted yesterday. In its application to Medsafe it says that in therapeutic doses, Sativex may produce side-effects "interpreted as a euphoria or cannabis-like high".
Source: stuff.co.uk © Fairfax New Zealand Limited 2007 (05/10/08)

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Sativex drug trial disappoints
GW Phamaceuticals said its pioneering cannabis-based medicine failed to show significant improvement in a final stage trial to treat neuropathic pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1740) in multiple sclerosis (MS) patients.
GW said Sativex had a very high patient response rate in the trial but that the results narrowly failed to reach statistical significance due to an unexpectedly large placebo response.
"While valid, this indicates that the effect of Sativex is marginal, and we retain our doubts as to whether the product will ever prove a commercial success," KBC Peel Hunt analyst Paul Cuddon wrote in a research note.
Nomura analyst Gary Waanders described the result as disappointing.
GW's managing director Justin Gover said there was a "desperate need" for new pain treatments and Sativex had a "real role" to play.
"The commercial proposition is not in question," Gover told Reuters. "It is a hazard of pain research that placebo effects occur in clinical trials and Sativex has seen this with this study."
GW, which grows thousands of marijuana plants at a secret location in the English countryside, said it would have to carry out another study in neuropathic pain.
"What this means is we are not able to speed things up," a GW spokesman added.
The study was one of three final Phase III trials for Sativex taking place this year.
GW said its study into spasticity (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1658) in MS patients, requested by the UK Regulator, was on track to report later this year. It also has a trial into cancer pain running in the United States also due in 2008.
"Our confidence in the outcome of our ongoing spasticity, cancer and pain studies is not affected by these results. Neither is our approach to gaining regulatory approval," Stephen Wright, GW's director of research and development, told an analysts' call.
Sativex, which is sprayed under the tongue, became the first cannabis-derived medicine to win regulatory approval when it was approved in Canada in 2005 as a treatment for neuropathic, or nerve, pain in MS patients.
But the drug has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.
Source: Yahoo! News © 2007 Yahoo (08/04/08)

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Doctors treat Multiple Sclerosis patients with cannabis
GPs refuse to wait for new spray to be licensed.

Scottish doctors have started prescribing cannabis on the NHS before it is officially licensed in a bid to relieve the pain (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=752) of multiple sclerosis sufferers.

Medics, apparently frustrated by years of trials of medicinal cannabis, have decided to wait no longer and are legally obtaining the drug Sativex (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1814) direct from the manufacturer.

Doctors are allowed to prescribe unlicensed drugs in the UK if they think it is in the best interest of their patient, but they are liable for any unforeseen consequences.

Sativex, which costs the NHS around £1,825 a year per patient, contains two purified forms of cannabis and is considered highly effective at controlling the pain and spasms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1658) associated with MS. It contains an extra ingredient which prevents the patient getting a 'high'.

Many cancer and MS sufferers resort to cannabis in its illegal form as pain relief and several have been prosecuted, including the late Biz Ivol, from Orkney, who made cannabis chocolates and posted them to fellow sufferers.

Trials of Sativex have been ongoing for at least four years and it will be later this year before the makers submit an application for UK licensing.

But prescription figures from the Information and Statistics Division of the Scottish Government's health department indicate that around a dozen patients are already being supplied with the drug by their doctors.

The true number of Scots receiving the drug is probably higher because those figures do not include prescriptions requested by hospital consultants.

Although cannabis is an illegal drug, the company which makes Sativex, GW Pharmaceuticals, based in Wiltshire, is allowed to do so under a special licence from the Home Office. This licence also allows doctors to prescribe it and patients to take it without breaking the law.

The treatment, which is taken as a spray under the tongue, contains cannabis as the main active ingredient and is treated to ensure patients do not experience a high. Cannabis blocks receptors in the brain that cause a patient to feel pain or experience muscle spasms, two symptoms (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=743) of MS.

Sativex has already been approved as a prescription medicine in Canada.

A spokesman for GW Pharmaceuticals said: "We are working very hard to finish clinical trials, which are necessary to get a full licence. The good news for patients is that the mechanism does exist that allows them to have access to this medicine. The final decision on whether to prescribe it to a patient is a matter for individual health boards."

One patient who has benefited from the drug is MS sufferer Joyce Fisher, from Dollar, Clackmannanshire. The 45-year-old former library assistant has had the condition for 15 years and is now confined to a wheelchair. Her GP agreed to prescribe Sativex after Fisher heard about the drug last year, and she took it for three months. However, she says her local health board, NHS Forth Valley, will no longer fund her treatment.

"Sativex eased the pain within the first two days and it also relieved the muscle spasms. It relaxed my body and allowed me to stand up and exercise."

Patients have long campaigned for the legalisation of cannabis for medicinal purposes. Scotland's best-known campaigner was MS sufferer Biz Ivol, from Orkney, who died in 2004 after falling ill with a chest infection and refusing any further medication.

Ivol was admonished at Kirkwall Sheriff Court in 1997 after she admitted growing 27 cannabis plants to relieve her pain. She produced cannabis chocolate bars, "cannachoc", for fellow sufferers.

Last night Linda Hendry, spokeswoman for the Legalise Cannabis Campaign Scotland and a former acquaintance of Ivol, said Sativex could have saved Ivol's life.

Treatments

Marijuana has some use in treating a variety of ailments.

It has been used to 'numb' the central nervous system – helping to reduce any associated muscle spasms with Alzheimer's disease, and as a treatment for sufferers of obsessive compulsive disorder and Tourette's.

Cannabinoids found within marijuana can relieve pain and stimulate appetite, which can aid cancer and HIV patients.

Source: news.scotsman.com ©2008 Johnston Press Digital Publishing (04/02/08)

[Sequoiacrone]

http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1814&CFID=34960&CFTOKEN=79207617

See the above link for more information about treating MS with Sativex....the last few previous studies in this thread came from MS Research Center, which I believe is sponsored by GW Pharmaceuticals, the mfg of Sativex.

Sativex is now in Phase III Clinical Trials in the US.


Sativex
(http://www.msrc.co.uk/#) Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose oro-mucosal spray; each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials. The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.
For more details on GW Pharmaceuticals, the makers of Sativex® and to contact them with any queries you may have in Canada please visit their website - GW Pharmaceuticals (http://www.gwpharm.co.uk/sativex.asp)
For any queries with regards Sativex®in the UK please contact Bayer Healthcare, GW’s marketing partner for the UK.
Direct Tel during working hours (9am-12:30pm, 1:30-5pm) 01635 563116 Direct Fax 01635 563657 Switchboard 01635 563000 E-mail medical.science@bayer.co.uk (medical.science@bayer.co.uk)Urgent Enquiries (between 12:30 - 13:30)
07876 577704 Out of hours enquiries 01635 563000