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Saturday, April 29, 2017

Keeping informed with A-Z multiple sclerosis information


                                                                  
  

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Monday, April 24, 2017

British scientists have discovered a potential cause for Multiple Sclerosis


                                                                  
  
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Brain
Scientists found a protein called Rab32 in the brains of people with MS
British scientists have discovered a potential cause for multiple sclerosis, in a major breakthrough that could pave the way for new treatments for the disease.

Scientists have found a new cellular mechanism which may cause the autoimmune disorder. Multiple sclerosis affects around 2.5 million people around the world.

Typically, people are diagnosed in their 20s and 30s, and it is more common in women than men.

Although the cause has so far been a mystery, the disease causes the body's own immune system to attack myelin - the fatty "sheaths" which protect nerves in the brain and spinal cord.


This leads to brain damage, a reduction in blood supply and oxygen and the formation of lesions in the body.

Symptoms can be wide-ranging, and can include muscle spasms, mobility problems, pain, fatigue, and problems with speech.


Scientists have long suspected that mitochondria, the energy-creating "powerhouse" of the cell, plays a link in causing multiple sclerosis.


Using human brain tissue samples, researchers at the Universities of Exeter and Alberta found a protein called Rab32 is present in large quantities in the brains of people with MS - but is virtually absent in healthy brain cells.

Where Rab32 is present, the team discovered that a part of the cell which stores calcium gets too close to the mitochondria.

The resulting miscommunication with the calcium supply triggers the mitochondria to misbehave, ultimately causing toxicity for brain cells in people with MS.

Researchers do not yet know what causes an unwelcome influx of Rab32 but they believe the defect could originate at the base of the cell.


The finding will enable scientists to search for effective treatmentsthat target Rab32 and embark on determining whether there are other proteins which could play a role in triggering MS.


Professor Paul Eggleton, of the University of Exeter Medical School, said: "Multiple sclerosis can have a devastating impact on people's lives, affecting mobility, speech, mental ability and more.

"So far, all medicine can offer is treatment and therapy for the symptoms - as we do not yet know the precise causes, research has been limited.

"Our exciting new findings have uncovered a new avenue for researchers to explore. It is a critical step, and in time, we hope it might lead to effective new treatments for MS."

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Thursday, April 20, 2017

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Genentech to Present New Data at AAN Reinforcing Efficacy And Safety of Newly FDA Approved Ocrevus (Ocrelizumab) in Two Types of Multiple Sclerosis


                                                                  
  
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Data presentations will include platform sessions and posters across relapsing multiple sclerosis and primary progressive multiple sclerosis

The press release is below and can be found HERE.    
South San Francisco, CA -- April 18, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on OCREVUS™ (ocrelizumab) in people with relapsing forms of multiple sclerosis (RMS) and primary progressive MS (PPMS) will be presented during the 69th American Academy of Neurology (AAN) Annual Meeting from April 22-28 in Boston, Massachusetts.
Data presented across three platform sessions will describe the rapid benefit of OCREVUS in RMS patients in the first eight weeks of treatment and its effect on fatigue in PPMS patients. Efficacy and safety data from the open-label extension study will also be presented, as well as the effect of OCREVUS on active disease and progression in PPMS.
“OCREVUS is the only disease-modifying therapy approved by the FDA for people with primary progressive MS and offers people with relapsing MS a new treatment option with a favorable benefit-risk profile,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The data being presented at AAN will demonstrate how rapidly OCREVUS controls disease activity and reduces brain MRI lesions in people with early RMS, both of which are important goals of treatment.”
Leading investigators will present the following oral and poster presentations:
Abstract Title
Abstract Number (type), Presentation Date, Time
Rapid Onset of Ocrelizumab Suppression of Brain MRI Activity in Relapsing-Remitting Multiple Sclerosis
S12.008 (oral), Monday, April 24, 2:24 p.m. EDT
Multimodal Evoked Potentials in Primary Progressive MS: A Potential Biomarker for Prognosis and Course
P2.350 (poster), Monday, April 24, 5:00 p.m. EDT
Rapidity of Onset of Ocrelizumab Clinical Efficacy in Relapsing Multiple Sclerosis
S31.002 (oral), Wednesday, April 26, 1:12 p.m. EDT
Preliminary Results of the OPERA I and OPERA II Open-Label Extension Study
S31.004 (oral), Wednesday, April 26, 1:36 p.m. EDT
The Association Between Confirmed Disability Progression and Patient-reported Fatigue in PPMS Patients in the ORATORIO study
S33.006 (oral), Wednesday, April 26, 4:30 p.m. EDT
No Evidence of Disease Activity on Ocrelizumab Treatment in Patients With Early Relapsing Multiple Sclerosis: Pooled Analysis of the Phase III OPERA Studies
P4.391 (poster), Wednesday, April 26, 5:30 p.m. EDT
Evaluation of No Evidence of Progression or Active Disease (NEPAD) in Patients with Primary Progressive Multiple Sclerosis in the ORATORIO Trial
P4.384 (poster), Wednesday, April 26, 5:30 p.m. EDT
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis
P5.407 (poster), Thursday, April 27, 5:30 p.m. EDT
Effects of Ocrelizumab on Neurofilament Light Chain and Other Biomarkers of Neuroinflammation and Neurodegeneration in MS: OBOE Study Design
P6.337 (poster), Friday, April 28, 4:00 p.m. EDT
Efficacy of Ocrelizumab on Brain MRI Outcomes in Patients with Early Relapsing Multiple Sclerosis: Pooled Analysis of the OPERA Studies
P6.338 (poster), Friday, April 28, 4:00 p.m. EDT
Advanced Myelin-related MRI Measures in Relapsing Multiple Sclerosis Patients Treated with Ocrelizumab or Interferon Beta-1a Over 96 Weeks
P6.371 (poster), Friday, April 28, 4:00 p.m. EDT
Full session details and data presentation listings for the 2017 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences/2017-annual-meeting/ .
OCREVUS received approval from the U.S. Food and Drug Administration (FDA) on March 28, 2017 for the treatment of adult patients with relapsing or primary progressive forms of MS.
Follow Genentech on Twitter via @Genentech and keep up to date with AAN 2017 Annual Meeting news and updates by using the hashtag #AANAM.
About OCREVUS ™ (ocrelizumab)
OCREVUS is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.
OCREVUS is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
OCREVUS U.S. Indication
OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.
It is not known if OCREVUS is safe or effective in children.
Important Safety Information
Who should not receive OCREVUS?
Do not receive OCREVUS if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive OCREVUS if you are a patient that has had a life threatening allergic reaction to OCREVUS. Patients should tell their healthcare provider if they have had an allergic reaction to OCREVUS or any of its ingredients in the past.
What is the most important information about OCREVUS?

OCREVUS can cause serious side effects, including:
·       Infusion Reaction: OCREVUS can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, fast heart beat.
These infusion reactions can happen for up to 24 hours after the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.
·       Infection: OCREVUS increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of OCREVUS. If a patient has an active infection, their healthcare provider should delay treatment with OCREVUS until the infection is gone.
·       Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
·       Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving OCREVUS.
·       Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.
Before receiving OCREVUS, patients should tell their healthcare provider about all of their medical conditions, including if they:
·       have ever taken, take, or plan to take medicines that affect the immune system, or other treatments for MS.
·       have ever had hepatitis B or are a carrier of the hepatitis B virus.
·       have had a recent vaccination or are scheduled to receive any vaccinations. A patient should receive any required vaccines at least 6 weeks before they start treatment with OCREVUS. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with OCREVUS and until their healthcare provider tells them that their immune system is no longer weakened.
·       are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm an unborn baby. Patients should use birth control (contraception) during treatment with OCREVUS and for 6 months after the last infusion of OCREVUS.
·       are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes OCREVUS.
What are possible side effects of OCREVUS?
OCREVUS may cause serious side effects, including:
·       Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations about standard screening guidelines for breast cancer.
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of OCREVUS.
Patients should call their doctor for medical advice about side effects. 
Patients may report side effects to the FDA at (800) FDA-1088 or
Patients may also report side effects to Genentech at (888) 835-2555.
For additional safety information, please see the OCREVUS full Prescribing Information and Medication Guide. 
For more information, go to http://www.OCREVUS.com or call 1-844-627-3887.

About Genentech in neuroscience
Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.
About Genentech
Founded 41 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
All trademarks used or mentioned in this release are protected by law.
 ###




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No Evidence of Disease Activity Achieved in Multiple Sclerosis with Dimethyl Fumarate


                                                                  
  
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Post hoc data analysis of the DEFINE and CONFIRM trials showed that a higher percentage of patients with relapsing-remitting multiple sclerosis (RRMS) achieved no evidence of disease activity (NEDA) with delayed-release dimethyl fumarate (DMF) compared with placebo. The results were published in the European Journal of Neurology.1
NEDA is a relatively new composite outcome that is being used more often to measure therapeutic response in multiple sclerosis. NEDA is comprised of 3 factors: no clinical relapse, no disability progression measured by the Expanded Disability Status Scale (EDSS) for 12 weeks, and no evidence of disease activity on magnetic resonance imaging (MRI).





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Monday, April 17, 2017

3D Laboratory Cell Growth System Should Speed Up MS Remyelination Research


                                                                  
  
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A physical scaffold that allows lab-grown brain cells to grow in a three-dimensional manner is giving scientists a whole new way of studying the regeneration of myelin, nerve coatings whose damage is at the heart of multiple sclerosis.
The scaffold is allowing researchers to test large numbers of compounds for their capacity to trigger remyelination. This could lead to an acceleration of research into regenerative drugs for MS

3D Laboratory Cell Growth System Should Speed Up MS Remyelination Research


“The aligned Mimetix scaffold fibres from AMSBIO have been an invaluable tool, allowing us to answer fundamental questions regarding how oligodendrocytes form central nervous system (CNS) myelin sheaths,” Marie Bechler, a senior researcher in the Constant laboratory at the MRC Centre for Regenerative Medicine in Scotland, said in a press release.
The three-dimensional orientation of cells in the central nervous system determines how cells grow and behave. Earlier methods of growing brain cells in a lab dish have been unable to mirror everything that goes on in a living human.
MRC Centre researchers are using the three-dimensional fiber technology that AMSBIO developed to study oligodendrocyte cells and myelin regeneration. Oligodendrocytes are cells that wrap their appendages around nerve cells to form myelin.

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Firefighter with Relapsing MS on Ocrevus: ‘I Have Really Good Days and I Have Bad Days’


                                                                  
  
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Texas firefighter Wayne Donovan is among the estimated 250,000 to 350,000 Americans with multiple sclerosis (MS). He enrolled in a clinical trial testing Ocrevus (ocrelizumab), which the  U.S. Food and Drug Administration recently approved as the first therapy for both relapsing and primary progressive forms of MS.
Donovan was diagnosed in 2011 at the age of 39, after he started feeling numbness in his hand and foot and saw a orthopedist, thinking he might have pinched a nerve. The orthopedist, however, recognized that it could be something more serious and referred him to neurologist Dr. Edward Fox at Central Texas Neurology Consultants in suburban Austin.
Fox diagnosed Donovan with relapsing MS — an unpredictable form of the disease.
Texas firefighter and MS patient Wayne Donovan. (Photo credit: Ocrevus)
“By the time I saw Dr. Fox, about three-quarters of my body was either numb or tingling, or had pins and needles,” Donovan said in a news release. “As a firefighter, I have to be strong and present in tough situation. I didn’t know what this meant for me and my family.”
The ultimate cause of MS is damage to myelin, nerve fibers and neurons in the brain and spinal cord, which together make up the central nervous system, causing inflammation and other debilitating symptoms. Relapsing MS is characterized by episodes of new or worsening signs or relapses, followed by periods of recovery.
Ocrevus targets immune B-cells that express a protein called CD20 on their surface, giving the drug an immunosuppressive function. The medication, developed by Genentech — a unit of the Roche Group — aims to reduce the immune system’s attacks on myelinated neurons, the main trigger of the disease.
Fox knew about a clinical trial that was investigating Ocrevus and suggested that Donovan enroll. After considering the pros and cons, Donovan enrolled and started receiving Ocrevus soon after. In the trial, the drug was administered every six months as an intravenous infusion.

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Wednesday, April 12, 2017

A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis


                                                                  
  


J Am Coll Nutr. 2017 Apr 10:1-19. doi: 10.1080/07315724.2016.1255160. [Epub ahead of print]

Author information



Abstract

OBJECTIVE:

The objective of this study was to examine whether participation in a 12-month multimodal intervention would improve mood and cognitive function in adults with progressive multiple sclerosis (MS).

METHODS:

In this one-arm, open-label feasibility trial, participants were prescribed a home-based multimodal intervention, including (1) a modified Paleolithic diet; (2) an exercise program (stretching and strengthening of the trunk and lower limb muscles); (3) neuromuscular electrical stimulation (EStim) of trunk and lower limb muscles; and (4) stress management (meditation and self-massage). Individuals completed measures of mood (Beck Anxiety and Depression Inventories) and cognitive (Cognitive Stability Index, Cognitive Screening Test, Delis-Kaplan Executive Function System) and executive function (Wechsler Adult Intelligence Scale) at baseline and 3, 6, 9, and 12 months after the start of the intervention. Dosage of the multimodal intervention was assessed at 3, 6, 9, and 12 months.

RESULTS:

The more individuals participated in the intervention activities, the greater improvements they had from baseline to 12 months on self-report measures of anxiety (Beck Anxiety Inventory [BAI]; ps = 0.001 to 0.02), depression (Beck Depression Inventory [BDI]; ps = <0.0001 to 0.09), cognitive function (Cognitive Stability Index [CSI/T], Delis-Kaplan Executive Function System [DKEFS]; ps = 0.001 to 0.06), and executive function (Wechsler Adult Intelligence Scale [WAIS]; ps = <0.0001 to 0.09). Mood and cognitive improvements were more closely related to a higher intake of the modified Paleolithic diet than to exercise and stress management dosage. Anxiety and depression changes were evident after just a few months, whereas changes in cognitive function were generally not observed until later in the intervention period. Mood and cognitive function changes from baseline to 12 months were significantly associated with fatigue improvements (ps = <0.0001 to 0.03).

CONCLUSIONS:

A modified Paleolithic diet, exercise, EStim, and stress management intervention like this one has the potential to improve the mood and cognitive symptoms that can lead to considerable suffering in people with MS, potentially improving quality of life and function for people with progressive MS.

KEYWORDS:

Multiple sclerosis; Wahl's Protocol; anxiety; cognitive function; depression; diet; electrical stimulation; exercise; mood; non-pharmacologic
PMID:  28394724


Terry Wahls, MD, MBA, IFMCP
Clinical Professor of Medicine
Department of Medicine
Carver College of Medicine
University of Iowa
200 Hawkins Drive
Iowa City, Iowa 52240
Secretary
319-356-4421