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Friday, May 9, 2014

MS Treatment ‘Cleans’ Your Blood

MS Treatment 'Cleans' Your Blood
Plasmapheresis removes antibodies and helps manage flares for people with relapsing MS. Here’s how it works.

Plasma exchange, also known as plasmapheresis, is a way to "clean" your blood. It works sort of like kidney dialysis. During the treatment, plasma -- the liquid part of your blood -- gets replaced with plasma from a donor or with a plasma substitute.
People with some forms of multiple sclerosis use plasma exchange to manage sudden, severe attacks, sometimes called relapses or flare-ups. Their plasma could have certain proteins that are attacking their own body. When you take out the plasma, you get rid of those proteins, and symptoms may get better.

How It Works

You can get plasma exchange in the hospital or at an outpatient center. The process isn't painful, and you won't need anesthesia.
You'll lie in bed or sit in a reclining chair.
A nurse or a specialist will put a needle attached to a thin tube, called a catheter, into a vein in each arm. If your arm veins are too small, you may have to have a needle in your shoulder or groin instead. 
Your blood comes out through one of the tubes and goes into a machine that separates your plasma from your blood cells. Then your blood cells get mixed with fresh plasma, and the new blood mixture goes back into your body through the other tube.
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Medical Marijuana May Ease Some MS Symptoms Finding applies only to pot in pill or spray form, neurologists say

WebMD News from HealthDay

But, experts say small study is not conclusive,
By Dennis Thompson
HealthDay Reporter

MONDAY, April 28, 2014 (HealthDay News) -- Medical marijuana can help relieve some symptoms of multiple sclerosis, but whether it can benefit patients with other neurological disorders is still unclear, according to a new review by top neurologists.
Doctors with the American Academy of Neurology reviewed current research and found certain forms of marijuana -- but not smoked marijuana -- can help treat MS symptoms such as muscle stiffness, certain types of pain and muscle spasms, andoveractive bladder.
"There are receptors in the brain that respond to marijuana, and the locations of the receptors are in places where you would expect them to help with these symptoms," said Dr. Barbara Koppel, a professor of neurology at New York Medical College in New York City and a fellow of the American Academy of Neurology.
But marijuana can't help tremors caused by MS or involuntary muscle spasms caused by the use of levodopa to treat Parkinson's disease, the physicians concluded.

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Tcelna Study for the Treatment of Secondary Progressive Multiple Sclerosis (MS)



Dr Daniel Kantor speaks with Dr Edward Fox from the MS Clinic in Central Texas, about the Tcelna study for the treatment of Secondary Progressive MS. -
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Multiple sclerosis discovery may explain gender gap


Multiple sclerosis Scientists said the S1PR2 protein was linked to multiple sclerosis

Related Stories

A key difference in the brains of male and female MS patients may explain why more women than men get the disease, a study suggests.
Scientists at Washington University School of Medicine in the US found higher levels of protein S1PR2 in tests on the brains of female mice and dead women with MS than in male equivalents.
Four times more women than men are currently diagnosed with MS.
Experts said the finding was "really interesting".
MS affects the nerves in the brain and spinal cord, which causes problems with muscle movement, balance and vision. It is a major cause of disability, and affects about 100,000 people in the UK.
Blood-brain barrier
Abnormal immune cells attack nerve cells in the central nervous system in MS patients.
There is currently no cure, although there are treatments that can help in the early stages of the disease.
Researchers in Missouri looked at relapsing remitting MS, where people have distinct attacks of symptoms that then fade away either partially or completely. About 85% of people with MS are diagnosed with this type.
Continue reading from here


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Mind-Controlled Robotic Arm Wins FDA Nod

May 9, 2014
SILVER SPRING, Md. -- The FDA Friday approved marketing of the first powered prosthetic arm that the user can control with his or her thoughts.
Made by New Hampshire-based DEKA Integrated Solutions, the device detects and translates electromyographic activity in nearby muscles -- which the user can consciously control -- into signals that direct specific movements and actions in the prosthetic arm.
It's the same size and weight as a normal adult arm and is capable of 10 different powered movements, according to the FDA.
Approval was based primarily on a trial in 36 participants who were patients in the Veterans Affairs medical system.
"The study found that approximately 90% of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair," the FDA said.
Continue reading from here
THINK of all the reasons why this and how, this robotic technology, can be used...  
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Preliminary clinical trial (with Estriol) shows great promise for new multiple sclerosis treatment

Los Angeles, California - A study conducted by Dr. Rhonda Voskuhl, a UCLA neurologist, shows that combining estriol, a female hormone, with Copaxone, a medication currently used to treat multiple sclerosis, reduced the relapse rate of MS by nearly 50 percent with only one year of treatment.
Voskuhl presented the results of the preliminary Phase II clinical trial today at the annual meeting of the American Academy of Neurology in Philadelphia.
The randomized, double-blind, placebo-controlled trial involved 158 women with relapsing-remitting MS. At 16 sites across the U.S., one group of women was treated with Copaxone, a commonly prescribed, standard-of-care drug for MS, and an 8 milligram estriol pill each day; others received Copaxone and a daily placebo pill. After 12 months of treatment, the relapse rate for the Copaxone-plus-estriol group was 47 percent lower than that of the group that took Copaxone plus a placebo. 
The test also showed that women who were taking Copaxone plus estriol scored higher on cognitive tests after one year than did women who were taking Copaxone and the placebo. 
Voskuhl found that, after two years, patients taking Copaxone and the placebo began to show improvement, but those results took longer to appear and were not as strong as those of the group taking Copaxone plus estriol. 
MS is an autoimmune and neurodegenerative disease that affects 400,000 people in the U.S. Relapsing-remitting MS, the most common form, can result in such permanent disabilities as loss of vision, paralysis and cognitive problems.
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New TYSABRI® Analysis at AAN Annual Meeting Shows Improved Walking Speed in Significant Number of MS Patients

New TYSABRI® Analysis at AAN Annual Meeting
 Shows 
Improved Walking Speed in Significant Number
 of MS Patients


Biogen Idec (BIIB) today announced that a post hoc analysis of data from the AFFIRM study shows TYSABRI® (natalizumab) significantly increased the proportion of relapsing-remitting multiple sclerosis (RRMS) patients with confirmed improvement in walking speed (CIWS) relative to placebo at two years. Additional data from observational registry studies show that switching to TYSABRI after experiencing a multiple sclerosis (MS) relapse while taking interferon beta (IFNβ) or glatiramer acetate (GA) reduced the risk of future relapses and treatment discontinuation. These data were presented at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia, Pa. (April 26-May 3, 2014).
“We know that MS has a significant impact on ambulation – a key concern for many people living with this disease – which is why we analyzed data from AFFIRM to evaluate the potential impact of TYSABRI on walking speed,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “TYSABRI was associated with a 20 percent increase in walking speed, a clinically relevant improvement, in a significantly greater number of patients compared to placebo.”
Walking Speed Impacted with TYSABRI
AFFIRM was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients with RRMS that evaluated the effect of TYSABRI on the progression of physical disability and the rate of clinical relapses. A post-hoc analysis of AFFIRM assessed the impact of TYSABRI on the proportion of patients with CIWS compared to placebo. CIWS was defined as ≥20 percent increase in walking speed from baseline in the timed 25-foot walk (T25FW) confirmed 12 weeks later.
Results show that, over the course of two years, CIWS was significantly associated with improvement in patient-reported physical functioning. Treatment with TYSABRI increased the proportion of patients with CIWS at year two by 79 percent compared to placebo (TYSABRI, 12.3%; placebo 6.9%; p=0.0133). These effects were more significant and occurred earlier in patients with more advanced disability – with CIWS being increased by as much as five-fold compared to placebo at one year.
While many MS clinical trials measure disability progression, which includes a measure of ambulation by the Expanded Disability Status Scale (EDSS), these data from AFFIRM suggest that CIWS may be a more sensitive endpoint in capturing improved ambulation in RRMS patients.
These data were presented in a platform presentation on Tuesday, April 29 at 2:15 p.m. ET:
  • Natalizumab Treatment Improves Walking Speed in MS Patients: A Post Hoc Analysis of AFFIRM (S4.006)
Efficacy Effect Observed With Switch to TYSABRI
Two additional studies used propensity-matched registry data to evaluate the effects of transitioning to TYSABRI after an on-treatment relapse while taking INFβ or GA, compared to remaining on, or switching between, INFβ and GA. Results show that switching to TYSABRI decreased the risk of future relapses, disability progression and treatment discontinuation for MS patients.
Because there are no randomized clinical trials comparing treatment options for patients with ongoing disease activity, comparisons of propensity-matched data from large observational cohorts are useful to estimate the relative risks associated with treatment decisions in a clinical setting. In these studies, researchers matched patients across three large observational clinical trials: TYSABRI Observational Program (TOP), an ongoing observational, open-label, 10-year prospective study of relapsing-remitting MS (RRMS) patients; MSBase, an ongoing, longitudinal database open to all practicing neurologists worldwide; and MSCOMET, a longitudinal MSBase registry substudy assessing the efficacy of IFNβ and GA in 1,000 patients in 14 countries.
In the first study, researchers matched 759 MS patients who participated in the MSCOMET study to the same number of patients in the TOP. They assessed time to first relapse, treatment discontinuation and disability progression over one year in those who relapsed on IFNβ or GA in the 12 months prior to study entry and either transitioned to TYSABRI or stayed on their original first-line therapy. Data show that switching to TYSABRI versus remaining on IFNβ or GA after an on-treatment relapse decreased the risk of relapse by 57 percent and reduced the risk of treatment discontinuation by 52 percent. Researchers also analyzed a smaller subset of patients (n=227 patient pairs) to assess disability progression. They found the incidence of three-month confirmed disability progression was lower in patients who transitioned to TYSABRI than in those who persisted on IFNβ or GA; however, this difference was not statistically significant, likely due to the small sample size and small number of observed progression events.
In the second study, CLICK HERE to continue with this read


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New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

May 5, 2014

New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.

The data indicated that peginterferon beta-1a dosed once every two weeks demonstrated favourable results on relapse rates, magnetic resonance imaging (MRI) findings and disease progression. Over two years, the safety profile of peginterferon beta-1a was consistent with other multiple sclerosis (MS) interferon therapies.

“The two-year data from ADVANCE further establish the efficacy and safety profile of peginterferon beta-1a demonstrated in the first year of the pivotal trial,” said Terry O’Regan, Vice President and Managing Director at Biogen Idec. “If approved, we believe that peginterferon beta-1a dosed once every two weeks will provide MS patients with one of the most significant developments in the interferon class in over a decade.”

ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety profile of peginterferon beta-1a administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received peginterferon beta-1a for the duration of the study.

New Analysis of ADVANCE Data Showed Peginterferon Beta-1a Benefits Maintained Over Two Years
A new analysis of data from the second year of ADVANCE presented at AAN demonstrated:
  • The efficacy of peginterferon beta-1a dosed once every two weeks was maintained throughout year two. Relative to year one, the annualised relapse rate (ARR) was further reduced and the number of new or newly-enlarging T2 lesions was numerically lower in year two
  • The safety and tolerability profile of peginterferon beta-1a was consistent between years one and two
These data were presented in a platform presentation on Tuesday, April 29 at 2:00 p.m. EDT:
  • Analysis of 2-year Clinical Efficacy and Safety of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis: Data from the Pivotal Phase 3 ADVANCE Study (S4.005)
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Thursday, May 8, 2014

Teva Announces COPAXONE® Recognized as “Brand of the Year” by Pharmaceutical Executive Magazine

Teva Announces COPAXONE® Recognized as “Brand of the Year” by Pharmaceutical Executive Magazine

JERUSALEM--(BUSINESS WIRE)--Thu, May 8, 2014,
Teva Pharmaceutical Industries Ltd., (TEVA) today announced that COPAXONE® (glatiramer acetate injection), the #1 global therapy for relapsing multiple sclerosis, has been named the 2014 “Brand of The Year” by Pharmaceutical Executive Magazine, a leading print and online publication for the biopharmaceutical industry.
“Teva and the COPAXONE® team are honored to be acknowledged by Pharmaceutical Executive, a respected voice in our industry,” said Mike Derkacz, Vice President, and General Manager of Teva CNS. “The award is a tribute to the hard work of Teva employees and scientists throughout the years; the growth of COPAXONE® and the loyalty of prescribers and patients alike; and speaks to the product’s benefits, tolerability and safety."
The “Brand of The Year” award was received on behalf of Teva by John Hassler, Vice President of Marketing for Teva CNS at an award ceremony hosted by Pharmaceutical Executive in New York. “For more than 20 years, Teva has consistently focused on making this brand an appropriate choice for many patients with relapsing forms of multiple sclerosis with rigorous clinical studies, product enhancements and patient support services like Shared Solutions®. Our most recent and significant product development is the new FDA approved, three-times-a-week dose of COPAXONE® 40mg. This honor is a testament to that work,” he said.
COPAXONE® was first approved for marketing by the U.S. FDA as a treatment for relapsing-remitting multiple sclerosis in 1996. Daily COPAXONE® 20 mg/mL is approved in more than 50 countries worldwide, including the United States, all European countries, Israel, Canada, Mexico, Australia and Russia.
On January 28, 2014, Teva announced that the U.S. Food and Drug Administration approved the Company’s supplemental new drug application (sNDA) for three-times-a-week COPAXONE® 40 mg/mL, a new dose of COPAXONE®. This new formulation allows for a less-frequent subcutaneous dosing regimen as compared to the COPAXONE® 20 mg/mL daily dose option.
About COPAXONE®

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Exercise can help you manage your multiple sclerosis symptoms

8 MS-Friendly Exercise Tips


By Beth W. Orenstein
Medically reviewed by Farrokh Sohrabi, MD

Exercise can help you manage your multiple sclerosis symptoms. Here's how to make sure your MS exercise routine is tailored to your needs.

Exercise is essential when you have multiple sclerosis (MS) — for your overall health and to help you manage MS symptoms. Exercise may even slow the progression of the disease, according to the findings of a study published in 2012 in the journal Therapeutic Advances in Neurological Disorders. However, you'll need to tailor your routine to your individual capabilities and limitations, which can change as MS progresses. Still, there are many exercises you can do with MS. You'll benefit by increased flexibility, decreased pain, and elevated mood. Start with these strategies to exercise smart with MS.

See more, click here

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Wednesday, May 7, 2014

Researchers use Gene Therapy to Build Immune Tolerance

Researchers use Gene Therapy to Build Immune Tolerance

University of Florida researchers have received a $40,000 grant from the National Multiple Sclerosis Society to test a gene therapy technique in mice that aims to help the body not treat itself like a foreign invader — a process referred to as immune tolerance — in the earliest stages of multiple sclerosis.

“In previous years, we have learned a lot about how to manipulate tolerance using gene therapy,” said Brad E. Hoffman, Ph.D., an assistant professor of pediatrics in the UF College of Medicine. “Tolerance is your body’s way of not responding to substances that would otherwise induce an immune response so you don’t have an immune response to everything. In multiple sclerosis, the body loses that ability to distinguish between self and not-self so it starts to attack its own nervous system cells.”

Typically, gene therapy is used to correct a faulty gene in the body. In this case, researchers will deliver a gene responsible for a brain protein into the liver, via the harmless virus AAV, in hopes that it will spark production of regulatory T cells. These T cells, which suppress the immune system, are crucial because they could effectively shut down the immune attack in the brain, Hoffman said. The researchers are injecting the gene specifically into the liver because the organ filters out unwanted immune responses.

“Everything filters through the liver for detoxification,” Hoffman said. “Because of this, the liver has an innate capacity to induce immune tolerance. We have learned in other gene therapy studies that it is possible for the liver to make cells tolerant to the gene you are putting in.”

Other research teams across the country are trying to spark immune tolerance to combat MS, too. However those studies involve developing treatments personalized for specific patients. The UF researchers’ work is novel because they hope to develop a technique that could be used on a wide number of patients.

“Everyone has different types of T regulatory cells and receptors,” Hoffman said. “By injecting a gene responsible for a brain protein, we are allowing an individual’s body to make the specific T regulatory cells it needs.

“If it works, this is potentially more clinically feasible, cost-effective and translatable for a large scale.”

Although gene therapy has yet to be used to correct autoimmune disorders such as MS, the foundations for the study are rooted in research that Hoffman’s team has performed while studying gene therapy for hemophilia. During these studies, the team was able to induce immune tolerance in mice, and Hoffman hopes the techniques will one day be able to help people with multiple sclerosis, too.

“Will we be able to cure MS? That would be ideal, but our strategy is more likely to result in suppressing the immune response to the nervous system,” he said. “If you suppress the immune response, you will suppress the neurodegenerative effects and hopefully maintain a higher quality of life.”




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