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Saturday, December 29, 2018

The Human Gut: The Next Frontier for MS Therapies

By: Jared Kaltwasser

The next important therapy for patients with multiple sclerosis (MS), might not be a drug — it might be a microbe.

That’s one possibility raised by new research into the human gut by researchers at the University of Iowa and the Mayo Clinic.

The scientists looked at a sampling of three gut microbes in a mouse model of MS. They found that 1 of the 3 – Prevotella histicola — was able to suppress immune disease.

Ashutosh Mangalam, PhD (pictured), assistant professor of pathology at the University of Iowa’s Carver College of Medicine, said the research is still very early but could prove important.

“Our study will provide the groundwork for future studies to test microbe-based therapies directly in the patients,” Mangalam said. “At this stage, we are actively working with our Mayo colleagues to explore the possibility of testing microbe-based therapies for patients with autoimmune diseases, especially multiple sclerosis, rheumatoid arthritis, and type 1 diabetes.”

Mangalam led a study published last year that found patients with MS have a distinct microbiota from healthy peers. Specifically, he found patients with MS had lower levels of “good” bacteria, such as that found in foods like soybeans and flaxseed.

  In the new study, Mangalam and colleagues found that when P. histicola was introduced into mouse models, it led to a decrease of pro-inflammatory Th1 and Th17 cells, while at the same time increasing disease-fighting T-cells, tolerogenic dendritic cells, and suppressive macrophages.

“Our study shows that a human commensal from the upper gastrointestinal tract possesses potent disease-protective characteristics and provides proof of principle that human commensal gut bacteria protect against neuroinflammation,” researchers wrote.

Mangalam cautioned against hasty conclusions. He noted that the safety and efficacy of these microbes still need to be tested in humans. But, if his hypothesis proves correct, microbe-based treatments could be available in the next 5 to 10 years.

The research also raises the possibility of one day predicting or preventing MS based on gut microbiota testing. In order for that to happen, Mangalam said scientists first need larger studies that can help establish a baseline for a “normal” gut microbiota.

He also said scientists need a better understanding of the different roles bacteria perform, or can perform, in individuals.

“We also have to remember that the gut microbiota analysis is the study of a community where different kinds of bacteria are needed to perform certain kinds of functions,” he said, comparing it to a city, where individuals  chefs, mechanics, tailors -- each have different specialties.

“Similarly, a healthy individual needs a diverse bacterial population, which will perform different kinds of functions, e.g. metabolizing plant-based metabolites such as fibers into short chain fatty acids (SCFA), and isoflavone/lignans into equol/enterolactone, etcetera,” Mangalam said. “What we need to understand better is which bacteria can do similar kinds of functions because different individuals might use different bacteria to perform same function such as production of SCFA from fibers.”

Mangalam said building out a better catalog of bacteria functions will help identify the potential for disease in patients.

The study, "Human Gut-Derived Commensal Bacteria Suppress CNS Inflammatory and Demyelinating Disease," was published online in Cell Reports this month.


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Study Links Food Allergies and Increased MS Disease Activity

December 21, 2018

Study Links Food Allergies and Increased MS Disease Activity

Multiple sclerosis (MS) patients who reported food allergies showed a 27 percent higher cumulative rate of flare-ups over the course of their disease, and more than twice the likelihood of having active inflammatory lesions, a new study shows.
The study, “Food Allergies are Associated with Increased Disease Activity in Multiple Sclerosis,” led by researchers at Partners MS CenterBrigham and Women’s Hospital at Harvard Medical School, was published in the Journal of Neurology, Neurosurgery & Psychiatry.
Several genetic and environmental factors have been associated with MS development.
Allergy to environmental triggers (like pollen, grass, or dust mites), certain medicines, or food (like nuts, shellfish, or wheat) have been suggested as potential risk factors for the disease. However, the data available so far have been inconclusive.
To determine whether there is an association between MS and allergy, researchers assessed 1,349 individuals with MS enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB) study. The average disease duration of the patients was 16 years.
Participants completed a self-administered questionnaire about environmental, medicinal, and food allergies.
Among participants, 427 had no known allergies; 922 had one or more allergies. Allergic patients were divided into three groups: those suffering from environmental allergies (586 patients), from food allergies (238), or from allergies associated with prescribed medication (574).
Researchers collected data on the total number of MS flare-ups/relapses each participant had experienced over the course of their disease, and data concerning their expanded disability status scale (EDSS), MS severity score (MSSS), and magnetic resonance imaging (MRI) scans. The MRI parameters analyzed were the presence and number of lesions detected. All these measures are indicative of the patient’s disease activity.
After statistically adjusting for other factors that could influence the outcome, results showed that patients reporting food allergies had a cumulative number of relapses that was 27 percent higher than patients with no known allergies.
In addition, patients in the food allergy group showed more than twice the likelihood of having lesions on MRI scans. In contrast, the environmental and medication allergy groups did not show significant differences when compared to those without allergies.

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Pretreating Ocrevus Patients with Multiple Antihistamines and Liquids Lowers Infusion Reactions by 60%, Study Reports

December 18, 2018
Pretreating multiple sclerosis patients with antihistamines more extensively and with hydration can significantly reduce — by 60% — the likelihood of infusion-associated reactions that are the most common side effect of Ocrevus (ocrelizumab) use, a pilot study reported.
Data also found that older and male MS patients are less likely to have such reactions to this therapy, while heavier patients are more likely.
The research, “Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol,” was published in the journal Multiple Sclerosis and Related Disorders.

Infusion-associated reactions (IARs) to Ocrevus — an approved MS therapy developed by Genentech, owned by Roche — were seen to decrease in rate and severity with subsequent administrations in primary progressive MS patients who took part in the ORATORIO Phase 3 trial (NCT01194570). But they remain a challenge for many on Ocrevus, and may cause patients to stop treatment at less experienced centers.
Read More


Spasticity Improved With Cannabinoid Oral Spray

Nancy A. Melville - December 24, 2018

Nabiximols, a cannabinoid-based oral spray (Sativex, GW Pharmaceuticals) approved outside the United States for various multiple sclerosis (MS) symptoms, shows benefit in improving spasticity and pain in motor neuron disease when administered as an add-on to standard therapy, new research suggests.  
"This study is, to our knowledge, the first randomized controlled trial of safety and efficacy of a pharmacological treatment for spasticity and the first trial of nabiximols in motor neuron disease," write the authors in their article published online December 13 in Lancet Neurology.
"Our results suggest that the study drug is well tolerated and provides first evidence of efficacy in terms of controlling spasticity in patients with motor neuron disease."
Current treatments commonly used for spasticity in motor neuron diseases such as amyotrophic lateral sclerosis (ALS), the most common and severe of these diseases, including baclofendantrolene, and benzodiazepines, lack evidence of efficacy in this context and are associated with undesirable side effects including increased muscle weakness or fatigue.
Nabiximols, an oral spray combining equal parts delta-9 tetrahydrocannabinol and cannabidiol (THC-CBD), has meanwhile gained favor in the treatment of spasticity in MS in countries outside of the United States where it is licensed, suggesting potential for efficacy in spasticity in other diseases.
For the current proof-of-concept study, first author Nilo Riva, MD, of the IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and colleagues enrolled 60 patients with at least 3 months of spasticity symptoms associated with known or suspected ALS or primary lateral sclerosis(PLS) who were already taking an anti-spasticity regimen for at least 30 days prior to enrollment.  
Patients were randomized to add-on treatment with nabiximols at an escalated dose to a predefined level titrated over 14 days or placebo for 6 weeks.
The study reached its primary endpoint with improvement in spasticity, assessed by change in the spasticity score of the Modified Ashworth Scale (MAS), which measures intensity of muscle tone, by a mean of 0.11 (SD, 0.48) in the nabiximols group (n = 59) compared with a deterioration of a mean of 0.16 (SD, 0.47) in the placebo group (n = 30; P = .01) over the course of the study.
Greater improvements were also observed in pain scores, reported on a scale of 0 to 10, with nabiximols (-0.97 vs -0.06) and in patient-reported global impression of change (P = .001).
Although there were no significant differences in other secondary endpoints, including sleep quality, spasms, spasticity, strength, upper and lower motor neuron tests, and scores on the Amyotrophic Lateral Sclerosis Functional Rating Scale — Revised, the scores suggested some benefit, Riva told Medscape Medical News.
"Although the effects on spasms, sleep disruption, and spasticity NRS scores were not significant, the direction of change was consistently in favor of the active treatment, and the pain NRS score improved significantly in nabiximols recipients," Riva said.
Medscape Medical News © 2018 WebMD, LLC 


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Friday, December 28, 2018

New stem cell research reveals what prevents remyelination

Dec 19, 2018

New research on remyelination could lead to a novel approach to developing treatments for multiple sclerosis. The findings suggest new targets for therapeutic intervention and how the disease environment in MS may prevent effective myelin repair and regeneration.

The findings by a University at Buffalo team reveal that activation of a specific transcription factor induces in adult stem cells a phenomenon called pathological quiescence, a situation in which the adult stem cells are rendered incapable of responding to injury by producing myelin-forming oligodendrocytes. The failure to remyelinate is the key feature of MS.

The study defines the role of the previously undescribed transcription factor known as PRRX1 in human oligodendrocyte progenitor cells, the cells that generate myelin-forming oligodendrocytes. The research demonstrated that PRRX1 expression results in the cell cycle arrest and quiescence of oligodendrocyte progenitors, which disabled the production of myelin.

In an animal model of leukodystrophy, the group of genetic disorders in which myelin fails to form or is destroyed in children, the researchers said that pathological quiescence induced by PRRX1 prevented cell colonization of white matter and effective myelin regeneration by transplanted human oligodendrocyte progenitors. They also found that blocking expression of this transcription factor prevented the negative effects of proinflammatory cytokines, such as interferon-γ, which regulates its expression.

Current MS research focuses largely on drugs that induce the differentiation of human oligodendrocyte progenitors. In contrast, the new research presents a novel concept for the development of new drugs based on blocking the pathological quiescence of progenitors.

Results of animal model studies sometimes do not translate to humans and may be years away from being a marketable treatment. However, the researchers said that finding that pathological quiescence is key to the inability to repair and regenerate myelin in MS provides a novel direction for the team's research.

The findings were published in Cell Reports.

Article source: MSF 
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Study uncovers potential risks of common MS treatment

In one of the most comprehensive studies to date, University of British Columbia researchers found an increased risk of events such as stroke, migraine, and depression, as well as abnormalities in the blood with taking beta interferon for multiple sclerosis. Researchers hope their study will lead to further research to develop biomarkers to help identify patients who are at the greatest risk of having an adverse event.

The study’s authors aimed to identify potential adverse events related to beta-interferon treatment for relapsing-remitting MS by analyzing health records of more than 2,000 British Columbians with MS between 1995 and 2008.

The researchers found a 1.8-fold increased risk of stroke, a 1.6-fold increased risk of migraine, and a 1.3-fold increased risk of both depression and abnormalities in the blood. The researchers stress that patients and physicians should not change their treatment plans. The study is based on population-level data and the risk to individual patients will vary greatly depending on individual factors.

In addition to the negative effects, researchers found a reduced risk of bronchitis and upper respiratory infections with taking beta interferon for more than two years. These infections can be common and problematic in people with MS.

According to MSFocus Senior Medical Advisor Dr. Ben Thrower, “Beta interferon therapies have been a mainstay of MS treatment since 1993. This class of drugs includes Betaseron, Extavia, Rebif, Avonex, and Plegridy. This study points out the need to continue safety monitoring with all medications, even those that have been around a while. The study noted an increased risk of depression and migraine headaches in people with MS treated with beta interferons. In my experience, these medications do not cause depression or migraines, but may worsen them in individuals already affected by those conditions. Regular medical follow-up and blood testing is recommended for those on beta interferon therapy. The point of this study is not to scare anyone away from this class of drugs, but to point out the need for routine follow-ups and monitoring.”

The study was published in the journal Neurology.
Article Source: MSF


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Cladribine (also known as Mavenclad™)

Experimental Medications: Administered Orally

Company: Merck
  • Oral medication taken for a maximum of 20 days over two years
  • Being studied in RRMS
Cladribine, which is marketed in several countries under the trade name Mavenclad, selectively targets the immune system’s B cells and T cells, leading to depletion of those cells. This is followed by a distinct pattern of “reconstitution,” as new B cells and T cells are produced. The medication has an interesting dosing regimen, with two annual courses given for a maximum of 20 days over two years. Its developers note that this approach avoids continuous suppression of the immune system.37
This medication received marketing authorization from the European Commission in August 2017. In December 2017, Canadian health authorities approved cladribine as a monotherapy for the treatment of adults with RRMS to reduce the frequency of clinical exacerbations and delay the progression of disability. Merck has said it plans to seek regulatory approval in other countries, including the United States.37
In announcing the Canadian approval, Merck noted that cladribine generally is recommended for patients who have had an inadequate response to, or are unable to tolerate, one or more other MS therapies. They added that in clinical trials, cladribine demonstrates efficacy across key measures of disease activity in patients with RRMS, including disability progression, annualized relapse rate, and MRI activity.37
In the 96-week, Phase III CLARITY trial, 1,326 patients with RRMS were randomized in a roughly 1:1:1 ratio to receive 3.5 mg of cladribine per kilogram (kg) of body weight, 5.25 mg/kg. Cladribine, or placebo, was given in two or four short courses for the first 48 weeks. This was followed by two short courses starting at Week 48 and Week 52, for a total of 8 to 20 days of treatment per year.38
Patients receiving cladribine at either dose had annualized relapse rates that were less than half the rate of individuals receiving placebo. Roughly 79 percent of the cladribine-treated patients did not have a relapse over the 96-week study period, as compared to 61 percent of people in the placebo group. Individuals receiving cladribine, at either dose, also had a lower risk of sustained progression of disability and a greater reduction in the number of brain lesions identified on MRI relative to the placebo group. However, patients receiving cladribine had a higher rate of adverse events. In particular, lymphopenia – abnormally low counts of white blood cells that play a role in fighting infection – was seen in 21.6 percent of those receiving the lower dose of cladribine, 31.5 percent of those on the higher dose of cladribine, and just 1.8 percent of people in the placebo group. Similarly, 20 patients receiving cladribine reported herpes zoster infection, while no one in the placebo group developed this infection.38
Other studies in the cladribine clinical development program include:
  • The CLARITY extension study: a two-year Phase III placebo-controlled study, following on from the CLARITY study to evaluate the safety and efficacy of cladribine over four years.
  • The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study to evaluate the efficacy and safety of cladribine as a monotherapy in patients at risk of developing MS because they have experienced a first clinical event suggestive of MS.
  • The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study to evaluate the safety and tolerability of adding cladribine to interferon-beta therapy in RMS patients who have experienced breakthrough disease while on interferon-beta.
  • PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) trial: an interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of cladribine. This will include more than 10,000 patient years of data with more than 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.37
At the Joint ECTRIMS-ACTRIMS Meeting in October 2017, Czech investigators reported that cladribine has an effect on relapses comparable to Gilenya® (fingolimod), and an impact on MS-related disability similar to Gilenya and interferon-beta. They added that cladribine may be associated with superior recovery from disability relative to Gilenya, interferon-beta, and Tysabri® (natalizumab).
They reached those conclusions by analyzing one-year relapse and disability outcomes for more than 5,200 patients in an MS registry. Using a method called propensity-score matching, they compared similar types of patients taking the various medications. While the size of the cladribine group was small – 37 patients versus 1,410 to 1,940 for the other three groups – statistical analyses supported the validity of the findings.39

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Understanding how the innate and adaptive  immune systems communicate through different players may help deepen our understanding of what causes MS and what perpetuates the disease. Lymphocytes play a central role, with B and T cell subsets each contributing to the disease in their own way.1

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Australia MS News: Expensive MS drug (Mavenclad) to be on PBS next year

A drug used to treat people with multiple sclerosis has been added to the Pharmaceutical Benefits Scheme.
 · Dec 23, 2018

When Australian Paralympian Carol Cooke is on #Mavenclad, she almost forgets that she has multiple sclerosis.
The cyclist and rower says that going on the medication has made "all the difference in the world" and changed her life.
Now, thousands of Australians who, like Cooke, are affected by the most common form of the disease could save about $54,000 a year thanks to the drug's listing on the Pharmaceutical Benefits Scheme.
With the PBS listing, sufferers of relapsing remitting MS will pay just $40.30 a script or $6.50 if they are concessional patients.
"This is Christmas a few days early for those who live with MS ... it's a gift from the Australian people, but it's a gift that is absolutely deserved," Prime Minister Scott Morrison told reporters on Sunday.

The plight of MS patients is close to Mr Morrison's heart as his brother-in-law Gary Warren has a different form of the autoimmune disease.
While there's no cure for MS, the federal government says the drug listing means patients will face fewer relapses, less disease activity in the brain and less progression of disability.
Carol Langsford, the chair of the Trish Multiple Sclerosis Research Foundation, said she believed her daughter Trish could still be alive if the drug was available in time.
Her daughter, a keen athlete, was 30 when she died in 2002 after spending four-and-a-half years in a nursing home.

Thursday, December 27, 2018

GB Sciences, LSU Partner on Cannabinoid Research and Development Project for MS, Other Diseases

Dec 12, 2018

GB Sciences, LSU Partner on Cannabinoid Research and Development Project for MS, Other Diseases

As debate continues about the effects of medical marijuana on multiple sclerosis (MS) and other diseases, cannabis company GB Sciences and Louisiana State University (LSU) have agreed on a cannabinoid research and development project.
This collaboration between a public and a private enterprise is a first in the therapeutic cannabis industry, according to a press release from GB Sciences. Louisiana permits the cultivation, extraction, processing, production, and sale of medicinal cannabis.
Specifically, the five-year Master Research and Development Agreement for the production of therapeutic cannabis targeting severe medical conditions and diseases is with LSU’s Agricultural Center. It results from a mutual wish to participate in joint projects related to the production of medicinal cannabis in the state.
Following a public bidding process, the center chose GB Sciences subsidiary GB Sciences Louisiana to cultivate and produce therapeutic cannabis for Louisiana patients with specific disorders, namely MS, cancer, human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS), cachexia (a condition that causes extreme weight loss and muscle wasting), seizure disorders, epilepsy, spasticityCrohn’s disease (an inflammatory bowel disease), muscular dystrophyglaucomaParkinson’s disease, muscle spasms, intractable pain, post-traumatic stress disorder, and some forms of autism.
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