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Friday, October 20, 2017

Corrona and the National Multiple Sclerosis Society announce intent to collaborate on a multiple sclerosis registry to study the comparative effectiveness and safety of approved therapies


WALTHAM, Mass.Oct. 20, 2017 /PRNewswire/ -- Corrona, LLC and the National Multiple Sclerosis Society have announced their intent to collaborate on the launch of the Corrona Multiple Sclerosis (MS) Registry to study the comparative safety and effectiveness of approved MS therapies. The first patient has been enrolled, with initial recruitment goals to register approximately 5,000 people with MS. This national, observational registry will collect and analyze longitudinal outcomes associated with multiple sclerosis therapies.
The MS registry is Corrona's sixth patient registry, adding to existing North American registries in rheumatoid arthritis, psoriatic arthritis and spondyloarthritis, psoriasis, inflammatory bowel disease, and a rheumatoid arthritis registry in Japan. The registry collects data from patients with MS and their treating neurologists through questionnaires and includes both physician assessments and patient-reported outcomes.  Corrona's team of biostatisticians and epidemiologists will collaborate with the National MS Society, participating academic and private practice neurologists, as well as supporting pharmaceutical companies, to study the comparative safety and effectiveness of approved MS therapies.
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Wednesday, October 18, 2017

MS could be reversed with existing allergy drug

By Tim Newman - Published

Nerve firing

A drug used to treat allergies has been shown to increase nerve speed in MS patients.

In a recent phase II clinical trial, an over-the-counter allergy drug was shown to improve nervous system function in patients with multiple sclerosis.

Multiple sclerosis (MS) is an autoimmune disease affecting more than 2.3 million people around the world. The condition attacks myelin, or the waxy coat around nerves, and compromises the nerves' ability to transmit messages.
Over time, as the nerves' function is steadily reduced, a range of symptoms - including problems with vision, muscle weakness, difficulty walking, and issues with balance and coordination - develop.
Current treatment focuses on preventing the immune system from causing further damage, and as it stands, no drugs can repair the damaged myelin.
Discovering a medication capable of rebuilding the damaged myelin would be a huge step forward. And according to the latest study, this may be just around the corner.
New MS drug on the horizon?
In 2014, studies carried out by Prof. Jonah R. Chan at the University of California, San Francisco showed that clemastine fumarate may be a candidate for the treatment of MS.
Because of the potential importance of the findings, the drug quickly progressed to clinical trials. This week, the results from a phase II clinical trial on clemastine fumarate are published in The Lancet.
Clemastine fumarate was first approved by the Food and Drug Administration (FDA) in 1977. It is an antihistamine medication for allergies and has been available over the counter since 1993. Its potential to treat MS is therefore as surprising as it is welcome.

According to principal investigator Dr. Ari Green, "To the best of our knowledge, this is the first time a therapy has been able to reverse deficits caused by MS. It's not a cure, but it's a first step toward restoring brain function to the millions who are affected by this chronic, debilitating disease."

The team studied the effects of clemastine fumarate on 50 individuals with long-standing MS over a 5-month period. Because the visual system is often one of the first to be affected, the researchers measured so-called visual evoked potentials (VEPs). This is a well-established method of assessing how quickly nerves conduct messages.

VEPs were measured by showing participants flickering patterns on a screen. Electrodes placed over the visual areas of the brain detected how long it took signals to travel from the eye to the relevant area of the brain.

For 90 days, half of the participants were given clemastine fumarate, and the other half received a placebo. Next, the groups were switched: the placebo group was given the drug and vice versa. Neither the participants nor the researchers knew which individuals were receiving the active treatments.

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Consortium of Multiple Sclerosis Centers (CMSC) Updates Proposed 2017 Guidelines for Standardized Brain and Spinal Cord MRI Protocols

Updated Guidelines Offer Recommendations for Use of Gadolinium Based Contrast Agents
CMSC Logo
​The Consortium of Multiple Sclerosis Centers (CMSC), in collaboration with the CMSC Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-up of Multiple Sclerosis (MS) updated the standardized MRI protocol useful when evaluating people suspected of having MS and for following individuals undergoing treatment for MS.  These guidelines evolved from a meeting of the task force comprised of an international group of neurologists, radiologists and imaging scientists with expertise in MS.  The group met in Newark, NJ, January 11-12, 2017 to revise and update the guidelines and indications for standardized brain and spinal cord MRI for MS including attention to the use of gadolinium, based on new data, survey results and expert opinion. These proposed recommendations are currently under review in preparation for a manuscript.  
Clinical guidelines from the CMSC for the diagnosis and follow-up of MS had previously recommended the routine use of gadolinium based contrast agents (GBCA) in brain magnetic resonance imaging (MRI) for the diagnosis and follow-up of patients with MS. Soon after the publication of these recommendations in 2015, the CMSC became aware of the concerns regarding gadolinium deposition in the brain and the recommendations of the FDA to limit GBCA use to appropriate clinical circumstances.
The proposed 2017 revised guidelines that are posted on the CMSC website, now state, “While there is no know central nervous system toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS.” This is an important change compared to the earlier recommendation. Other key changes to the MRI protocols since the 2009 include emphasis on 3D sequences for brain MRI, Progressive Multifocal Leukoencephalopathy (PML) specific monitoring protocol, and optional orbit MRI protocol for severe optic neuritis.




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Tuesday, October 17, 2017

One More Small Piece of the Puzzle on the Role of Gut Micro-organisms in MS

October 16, 2017  ----  by Ana Belo van Wijk, PhD

Researchers found a significant increase in some types of gut bacteria and lower levels of an anti-inflammatory factor in untreated multiple sclerosis twins.
The study offered working evidence that components of gut microbiota contribute to autoimmune diseases like MS.
One More Small Piece of the Puzzle on the Role of Gut Micro-organisms in MS

Researchers published their article in the journal Proceedings of the National Academy of Sciences.It was titled “Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice.”

Our gut contains millions of good bacteria, fungi, bacteria-like archaea, and viruses that we can’t live without. Although there are 300 to 1,000 species of bacteria in our gut, most of our intestines is populated with 30 or 40 species.

Recent increases in knowledge and technical advancements have made it possible for scientists to measure the equilibrium between different species in the gut, and analyze their influence on our health.

One discovery was a link between the balance of bacteria in the intestines and autoimmune diseases like MS.

A team of researchers decided to see if differences in gut microbiota play a role in MS progression and perhaps its onset.

They analyzed the feces of 34 identical twins, one of each who had MS and one of each who didn’t. They used twins to try to reduce genetic and environmental differences’ influence on the onset of the disease.

All of those with MS were Caucasian and had grown up with their healthy twin to adulthood.

Researchers analyzed the type and abundance of microorganisms in the feces of both the MS-affected and healthy twins.

They found no differences in species or amount of bacteria between siblings. What they did find was a significant increase in some types of bacteria, such as Akkermansia, in untreated twins with MS.

The team transplanted fecal samples from MS-affected and healthy twins into a mice model of MS called experimental autoimmune encephalomyelitis. These animals have an inflammatory myelin-destroying disease of the central nervous system that is comparable to human MS. Myelin is a protective coating around neurons whose loss is associated with MS.

MS twin-derived gut microbiota caused a significantly higher amount of mice to develop a relapsing–remitting autoimmunity similar to MS than healthy twin-derived microbiota.

When researchers measured the microbial profiles of the mice’s feces, they found significant differences in amounts of bacteria. The most important difference was in Sutterella, an organism that helps protect against inflammation. Sutturella levels were significantly reduced in the feces of mice transplanted with MS twin-derived microbiota compared with feces from healthy twins.

The team also measured the mice’s immune cells and the proteins they release.

They discovered that immune cells in mice with MS-twin feces transplants produced less of the anti-inflammatory factor IL-10 than immune cells from mice colonized with healthy-twin samples. IL-10, or interleukin 10, is an important immune protein.

When researchers transplanted the feces of healthy twins into the mice, then gave them an antibody that blocks the function of IL-10, they also became sick. This indicated that IL-10 may temper autoimmunity in the central nervous system.

The team then measured the twins’ immune blood components. They found that the healthy twin had higher quantities of IL-10 than the MS-affected one.

“These findings provide evidence that MS-derived microbiota contain factors that precipitate an MS-like autoimmune disease” in a mouse model, the researchers wrote.

continued


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Ocrelizumab Offers Greater Value Than Interferon

J Med Econ; 2017 Oct; Frasco, Shih, Incerti, et al
October 17, 2017

Ocrelizumab provides greater value to relapsing forms of multiple sclerosis (RRMS) patients compared with subcutaneous interferon beta-1a (IFNβSC), according to a recent investigation. Initiating ocrelizumab at lower Expanded Disability Status Scale (EDSS) levels leads to a greater cumulative value due to slower disability progression, which extends years with higher quality-of-life.



A Markov model was developed to compare disability progression as measured by EDSS and relapse outcomes over a 30-year horizon for ocrelizumab vs IFNβSC. Direct, indirect, and informal costs (2016 US dollars) and utilities for EDSS health states were obtained from the literature. Investigators found:

Ocrelizumab was associated with an incremental gain of 0.84 quality-adjusted life years (QALYs) and cost savings of $287,713 relative to IFNβSC, resulting in an incremental net monetary benefit (INMB) of $413,611 per person over 30 years.

The INMB increased by $151,763 for those initiating ocrelizumab at EDSS level 1 vs level 4.
Influential parameters were QALY value, treatment costs, and disability progression; however, all sensitivity analyses indicated that the INMB for ocrelizumab relative to IFNβSC was ≥$300,000 per person.

Citation:
Frasco MA, Shih T, Incerti D, Espinosa OD, Vania DK, Thomas N. Incremental net monetary benefit of ocrelizumab relative to subcutaneous interferon β-1a. J Med Econ. 2017;20(10):1074-1082. doi:10.1080/13696998.2017.1357564.

source

                                                       https://www.ocrevus.com
                                         


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TRANS-CRANIAL Direct Stimulation (tDCS): Promising Remedy for MS Fatigue Reduction

Mult Scler; ePub 2017 Sep 22; Charvet, et al
October 17, 2017

Transcranial direct current stimulation (tDCS) is a promising option for fatigue reduction in multiple sclerosis (MS), according to 2 recent studies. Dorsolateral prefrontal cortex left anodal tDCS was administered using a remotely supervised (RS)-tDCS protocol, paired with 20 minutes of cognitive training. Study 1 delivered 10 open-label tDCS treatments (1.5 mA; n=15) compared to a cognitive training only condition (n=20). Study 2 was a randomized trial of active (2.0 mA, n=15) or sham (n=12) delivered for 20 sessions. Fatigue was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)—Fatigue Short Form. Researchers found:

In Study 1, there was modest fatigue reduction in the active group (−2.5 ± 7.4 vs −0.2 ± 5.3).

However, in Study 2 there was statistically significant reduction for the active group (−5.6 ± 8.9 vs 0.9 ± 1.9).

Citation:
Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. [Published online ahead of print September 22, 2017]. Mult Scler. doi:10.1177/1352458517732842.

source


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Evidence-Based Cognitive Rehab for Persons with MS

October 17, 2017 - ePub

Arch Phys Med Rehab; ePub 2017 Sep 25; Goverover, et al


Substantial progress has been made in regard to the identification of effective treatments for cognitive impairments in persons with multiple sclerosis (MS), according to a recent updated literature review from 2007 through 2016. Searches of literature were conducted using combinations of the following terms: attention, awareness, cognition, cognitive, communication, executive, executive function, language, learning, memory, perception, problem solving, reasoning, rehabilitation, remediation, training, processing speed, and working memory. 129 articles were identified and underwent initial screening; 59 articles were selected for inclusion after initial screening; 19 studies were excluded after further detailed review; and 40 studies were fully reviewed and evaluated. Investigators found:

The review yielded 6 class I studies, 10 class II studies, and 24 class III studies.
1 intervention in the area of verbal learning and memory received support for a practice standard, 2 computer programs received support as practice guidelines (in the area of attention and multi-cognitive domains), and several studies provided support for 5 practice options in the domains of attention and learning and memory.

Citation:
Goverover Y, Chiaravalloti ND, O’Brien A, DeLuca J. Evidenced based cognitive rehabilitation for persons with multiple sclerosis: An updated review of the literature from 2007-2016. [Published online ahead of print September 25, 2017]. Arch Phys Med Rehab. doi:10.1016/j.apmr.2017.07.021.

source




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Surgeries Offer Relief for Neuralgia Pain in MS

Oct 17, 2017 - Holland

Stereotactic radio surgery (SRS) and radiofrequency rhizotomy (RFR) provide effective pain relief for trigeminal neuralgia (TN) in the setting of multiple sclerosis (MS), according to a recent study. While initial surgical cost of RFR and SRS were different, subsequent and total cost of the 2 modalities were not significantly different. Researchers evaluated patients with TN and MS (n=17) who were treated since 1997. Patients either underwent SRS (n=7) or RFR (n=10) as their index procedure and were evaluated as a group based on this first procedure. The median age of patients at first operation in each group was 58.5 ± 10.9 and 63.5 ± 7.5 for SRS and RFR, respectively. They found:

Overall, 71% of patients had an excellent or good initial pain outcome.
Over time, 60% of RFR and 29% of SRS patients required additional procedures to obtain satisfactory pain relief.

The patients who underwent RFR as their index procedure required a significantly higher number of procedures to achieve adequate pain relief (RFR=2.7 vs SRS=2.0).
Citation:

Holland MT, Teferi N, Noeller J, et al. Stereotactic radio surgery and radio frequency rhizotomy for trigeminal neuralgia in multiple sclerosis: A single institution experience. [Published online ahead of print September 7, 2017]. Clin Neurol Neurosurg. doi:10.1016/j.clineuro.2017.09.004.

Source



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Monday, October 16, 2017

MS risk in children spotted with MRI brain scans

Date:
October 14, 2017
Source:
Yale University
Summary:
By the time multiple sclerosis (MS) is diagnosed in children, it may be difficult to prevent the disabilities and relapses that come with the disease. In a new study, researchers examined MRI brain scans to identify children at high risk of developing MS before symptoms appear, which may lead to earlier diagnosis and treatment.

By the time multiple sclerosis (MS) is diagnosed in children, it may be difficult to prevent the disabilities and relapses that come with the disease. In a new Yale School of Medicine study, researchers examined MRI brain scans to identify children at high risk of developing MS before symptoms appear, which may lead to earlier diagnosis and treatment.

Published in the November issue of the journal Neurology: Neuroimmunology & Neuroinflammation, the study of 38 children at 16 sites in six countries showed that the MRIs can reveal changes in the brain associated with MS before the clinical symptoms of the disease appear in children.

The children in the study all underwent MRI scans for other reasons, most commonly headache, but the MRIs unexpectedly revealed signs of MS. Having MRI findings of MS without any symptoms of the disease has been termed radiologically isolated syndrome (RIS) and previously had only been seen in adults.

"For the first time we have proposed a definition of RIS in children," said lead author Naila Makhani, M.D., assistant professor of pediatrics and neurology at Yale School of Medicine. "Children with RIS may represent a high-risk group of children that needs to be followed more closely for the later development of clinical multiple sclerosis."

Approximately 42% of children in the study with MRI findings of MS developed the first clinical symptoms of the disease about two years after the abnormal MRI, which shows a faster development of the disease than has been reported in adults. Children who had a specific marker in spinal fluid or who had MRI changes in the spinal cord, were at greatest risk of developing the clinical symptoms of MS.

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Thursday, October 12, 2017

Medical Marijuana, Inc. Targets New $11 Billion Market Opportunity as World Anti-Doping Agency Removes CBD From Banned Substances List

9:00 am ET October 10, 2017 (PR Newswire) Print
Medical Marijuana, Inc. (MJNA), the first publicly traded cannabis company in the United States, today announced that it will move forward with market expansion efforts in athletics with recent announcement by the World Anti-Doping Agency (WADA), the foundation initiated by the International Olympic Committee to coordinate and monitor drug use in sports, that cannabidiol (CBD) will be removed from its list of banned substances in 2018.
Medical Marijuana, Inc.'s Real Scientific Hemp Oil-X(TM) (RSHO-X)(TM) CBD hemp oil, which is the only product on the market to be recognized by international governments to be completely free of tetrahydrocannabinol (THC), the well-known psychoactive compound in marijuana, is an ideal option for athletes looking to safely incorporate cannabinoids into their regimen. Derived from industrial hemp and imported from Europe through the world's first CBD pipeline, RSHO-X was the first cannabis product approved by the Mexican Federal government for import from the US and is currently being prescribed for various indications such as epilepsy, diabetic neuropathy and pain associated with cancer treatment.
"This decision by the WADA is on par with what the rest of the medical world and countries around the world are realizing about the therapeutic benefits of CBD and athletes specifically need solutions in the areas of nutrition, relaxation, focus, recovery and repair," said Medical Marijuana, Inc. CEO Dr. Stuart Titus. "For athletes, our first-of-its kind THC-free RSHO-X eliminates the concern of a violation for athletes or anyone else liable to drug tests."
In 2015, Wada tested over 300,000 athletes worldwide with around 4% showing signs of cannabinoids in their system, which under previous regulations included CBD and would automatically disqualify any athlete testing positive. This new regulation will allow these athletes to use products made by the Company without fear of failing these types of tests. The sports nutrition market continues to grow with Euromonitor International estimating spending in the category to be around $11 billion in 2015 and projecting it to grow to $14 billion by 2019. The Company plans to further efforts to capture additional market share with their cannabinoid products since the recent announcement by WADA.
About Medical Marijuana, Inc. Our mission is to be the premier cannabis and hemp industry innovators, leveraging our team of professionals to source, evaluate and purchase value-added companies and products, while allowing them to keep their integrity and entrepreneurial spirit. We strive to create awareness within our industry, develop environmentally-friendly, economically sustainable businesses, while increasing shareholder value. For details on Medical Marijuana, Inc.'s portfolio and investment companies, visit www.medicalmarijuanainc.com.
To see Medical Marijuana, Inc.'s video statement, click here. Shareholders are also encouraged to visit the Medical Marijuana, Inc. Shop for discounted products.
About HempMeds(R) HempMeds(R) offers mainstream marketing, sales, customer service, and logistics for the cannabis industry. HempMeds(R) is a corporate portfolio company of Medical Marijuana, Inc. (OTC Pink: MJNA) and the Company's exclusive master distributor and contracted marketing company. In addition to handling sales and distribution, HempMeds(R) is the communication hub for the Medical Marijuana Inc. portfolio of companies.
FORWARD-LOOKING DISCLAIMER AND DISCLOSURES This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties. The statements in this press release have not been evaluated by the FDA and are not intended to diagnose, treat or cure any disease. The Company does not sell or distribute any products that are in violation of the United States Controlled Substances Act. The Company does sell and distribute hemp-based products.
CONTACT: Public Relations Contact: Andrew Hard Chief Executive Officer CMW Media P: 888-829- 0070 andrew.hard@cmwmedia.com www.cmwmedia.com
View original content:http://www.prnewswire.com/news-releases/medical-marijuana-inc-targets-new-11-billion-market-opportunity-as-world-anti-doping-agency-removes-cbd-from-banned-substances-list-300533720.html
SOURCE Medical Marijuana, Inc.



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