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Friday, January 20, 2012

The FDA has approved the first test for assessing the risk of progressive multifocal leukoencephalopathy (PML) in patients on natalizumab (Tysabri)


By Kristina Fiore, Staff Writer, MedPage Today
Published: January 20, 2012




The Stratify JCV Antibody ELISA test screens for the presence of antibodies to the JC virus, a risk factor for PML in patients with multiple sclerosis or Crohn's disease who are taking the monoclonal antibody, the agency said in a statement.

Natalizumab was pulled from the U.S. market in 2005 after the first of some 200 cases of PML came to light, but it was allowed back on the marketin 2006 after the development of a risk evaluation and mitigation strategy (REMS).

Risk of PML should be calculated not only by the antibody test results, but should also be based on the length of time the patient has been on natalizumab (more than two years increases the risk) and if the patient is taking other immunosuppresants, the FDA said.



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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Turning Basic Research into Better Patient Treatments



The Myelin Repair Foundation is

Eliminating the Valley of Death

Watch our video to see how the black hole of scientific research called the Valley of Death is preventing treatments from getting into the hands of patients, and why the Myelin Repair Foundation is working around the clock to fix this.


This Video was made possible by Scott Johnson, President and Founder of the Myelin Repair Foundation and MS patient advocate





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 Click to: REGISTER For our MS weekly e-Newsletter
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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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HEADLINE NEWS: Novartis drug investigated after 11 deaths



Jan 20, 2012

LONDON (AP) - A multiple sclerosis drug made by industry giant Novartis is under investigation after at least 11 patients taking the medicine died.

The drug, Gilenya, was licensed last year in the European Union to treat patients with a severe type of multiple sclerosis.
The deaths raise concerns Gilenya could trigger heart problems after patients take their first dose, according to a statement issued Friday by the European Medicines Agency. The agency, which is now investigating the drug, said it isn’t clear if it caused the deaths.
One of the deaths was in the U.S., where a patient died within 24 hours of taking the first dose.

READ MORE



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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Forks over Knives - Could degenerative disease be controlled by what we eat



The Multiple Sclerosis Foundation is hosting a FREE screening of Forks over Knives in Fort Lauderdale which examines the profound claim that most, if not all, of the degenerative diseases that afflict us can be controlled, or even reversed, by rejecting animal-based and processed foods.  If you are in the Fort Lauderdale area we invite you to join us at our viewing and after party; if you are not in South Florida we encourage you to consider hosting your own screening in your community. 

Please contact Nathalie Sloane at nsloane@msfocus.org 
or (800) 225-6495 for more information.





Information provided for the MS Foundation by Stu's Views & MS News


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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Having Troubles Concentrating?


Having Troubles Concentrating?
While MS often introduces memory
and thinking trouble, other distractions
can steal your concentration. Top offenders.



Also See:  • MS Symptoms Explained
  • The Sleep You Need to Manage MS
  • More About MS-Related Fatigue



Information provided by webMD



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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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"The Treatment and Management of MS Exacerbations"



A live online webinar on

Thursday, February 2, 2012
7 pm - 8 pm Eastern Standard Time



Register for this webinar
Managing the unpredictability of MS is always challenging, especially for individuals with relapsing-remitting MS. When new symptoms appear or existing symptoms become worse (known as exacerbations or flare-ups), successful management often involves accurately defining the relapse and understanding the variety of treatment options to best address the issue.

Join MS expert Dr. Ben Thrower as he offers valuable insights into understanding the signs and symptoms of an MS exacerbation, provides guidance on when to alert your neurologist, and discusses treatment options including steroids and other effective medications.

Register for this webinar by visiting the following link:support.msassociation.org/exacerbations




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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Therapy May Reverse Multiple Sclerosis Effects due to Myelin Damage



January 18, 2012 1:37 PM EST
Researchers have found a new therapeutic method that may restore damaged myelin sheaths lost during Multiple Sclerosis in a proof-of-principle study published in the journal Cell Stem Cell.
The animal study found that exposing old animals to circulatory systems of young animals may regenerate myelin sheaths surrounding the nerves lost during Multiple Sclerosis.
The study was carried about by researchers from Joslin Diabetes Center, Harvard University, and the University of Cambridge.
"Aging impairs regenerative potential in the central nervous system," says author Amy J. Wagers, PhD.
Wagers is an associate professor of stem cell and regenerative biology at Harvard University and Joslin. She co-led the study with Professor Robin Franklin, director of the MS Society's Cambridge Centre for Myelin Repair at the University of Cambridge
Researchers using a surgical technique introduced experimental demyelinating injury in the spinal cord of an old mouse, creating small areas of myelin loss, and then exposing that area to cells found in the blood of young mouse.  Immune cells from the young mouse helped old mouse stem cells to restore effective remyelination of the spinal cord.
"This means that, in theory, regenerative therapies will work throughout the duration of the disease," said Franklin.
This could be particularly useful, in treating MS, according to the researcher.
"This impairment can be reversed, however, suggesting that the eventual development of cell-based or drug-based interventions that mimic the rejuvenation signals found in our study could be used therapeutically", said Franklin.


..Comments for each blog posting are always appreciated. 
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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Initiation of Phase II Clinical Trial of Trimesta™ for Cognitive Dysfunction in Multiple Sclerosis



ANN ARBOR, Mich.Jan. 19, 2012 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the initiation of the Phase II clinical trial of Trimesta™ (oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis (MS). This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., Director, UCLA Multiple Sclerosis Program, Department of Neurology. There is currently no approved therapy for the treatment of cognitive dysfunction in MS.
"We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability," said Dr. Voskuhl, Principal Investigator. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."
This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta™ therapy (p = 0.04).[i] The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.[ii]
The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta™ (oral estriol) or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta™ for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at http://www.clinicaltrials.gov/ct2/show/NCT01466114.
In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta™ is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS. With over $8 million in grant funding awarded to date, this separate ongoing Trimesta™ clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.


..Comments for each blog posting are always appreciated. 
     Please use the link found below, to leave comments.. .. All comments are moderated to reduce SPAM and bad language
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"MS Views and News"  is a 501©(3) Not-For-Profit organization
 as recognized by the Internal Revenue Service

All contributions are tax deductible to the fullest extent allowed by law
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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