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Thursday, June 5, 2014

Biogen Idec Investigates Tysabri in Secondary-Progressive Multiple Sclerosis Patients

Biogen Idec is currently sponsoring a clinical trial evaluating its therapy Tysabri (natalizumab) in patients with secondary-progressive multiple sclerosis. Although relapse-remitting multiple sclerosis is more common and well-researched, the National Multiple Sclerosis Society estimates approximately half of relapse-remitting patients will transition to secondary-progressive within 19 years of diagnosis.
Biogen IdecThe Phase 3b clinical trial is a multicenter, international study known as “A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis,” or simply “ASCEND in SPMS.” It is a two-part study, with part one placebo-controlled and part two open-label.
The primary objective of the placebo-controlled study is to evaluate slowed disability progression in patients treated with natalizumab. Patients will be evaluated with the Expanded Disability Status Scale, Timed 25-Foot Walk, and/or 9-Hole Peg Test. Secondary objectives will focus on clinical outcomes such as brain volume using MRI scans.
During the open-label extension study, patients will be monitored for adverse and serious adverse effects to solidify the safety profile of natalizumab. Secondary measures will continue to evaluate disability progression.
An estimated 856 patients are participating in the trial, and natalizumab will be administered once a month intravenously. Patients will receive treatment for a total of 96 weeks, and the study duration is 108 weeks. The trial is predicted to end in December 2014.


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International committee re-defines how multiple sclerosis is described and understood

posted by news on june 4, 2014 

Multiple sclerosis manifests itself in many different ways and different courses. A recent effort to fine-tune descriptions – or phenotypes -- of MS was undertaken by an international team of leaders in MS research and clinical care. The results of this effort by the International Advisory Committee on Clinical Trials in MS, including recommendations for more research, has just been published (Neurology 2014;83:1). The volunteer Committee is jointly supported by the National MS Society and the European Committee for Treatment and Research in MS (ECTRIMS).

"Having better definitions of different types of MS would greatly facilitate research studies, communications between people with MS and their healthcare providers, and treatment decisions," noted Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer of the National MS Society.

In 1996 the Committee had developed consensus around descriptions of the courses of MS to facilitate research in MS and so that researchers and clinicians around the world would have a common understanding of the types of MS discussed in publications and in the clinic. This consensus highlighted four courses of MS -- relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. While these descriptions of MS have become well-established, understanding of MS has advanced, prompting a re-evaluation of the course of MS and any biological signposts (such as blood markers or imaging) that might help refine these phenotypes.

After a thorough search of the medical literature and convening an international workshop funded by collaborators worldwide (National MS Society, ECTRIMS, Americas Committee for Treatment and Research in MS, MS International Federation, and MS Society of Canada), the Committee published recommendations that modify prior clinical course descriptions. The Committee recommended retaining major courses of MS – relapsing-remitting, secondary-progressive and primary progressive -- but recommended categorizing progressive relapsing as an active form of primary progressive MS.



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HAPPY BIRTHDAY to the MSAA



Happy Birthday to MSAA
Happy Birthday to MSAA Happy Birthday to the MSAA!  

MSAA has been helping to improve lives in the MS community for over 44 years!

 This June marks their 44th birthday. 

MSAA = MS Association of America







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MS Views and News / Stu's Views & MS News 
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Abstracts from the 2014 CMSC ACTRIMS Meeting are now available!

Abstracts from the 2014 CMSC ACTRIMS Meeting are now available!  

We would like to inform you that abstracts presented at the 2014 Cooperative Meeting of the CMSC and ACTRIMS, held from May 28 to 31, 2014, in Dallas, Texas, have been published in an electronic supplement to the International Journal of MS Care, which is available at the IJMSC website at http://ijmsc.org/toc/ijmc/16/S3.   





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REPAIR, REGENERATE & RENEW: Cutting-Edge Stem Cell Research

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REPAIR, REGENERATE & RENEW: Cutting-Edge Stem Cell Research at Tisch MS Research Center of New York

Our adult stem cell treatment received FDA approval for a Phase I Clinical Trial that has the potential to repair the damage caused by MS.
This exciting milestone took over ten years to reach and brings indescribable hope to MS patients and their loved ones all over the world. 

REPAIR

Our stem cell therapy is the star of the research program at the Tisch MS Research Center of New York (Tisch MSRCNY), a 501(c)(3), independent, non-profit research center dedicated to finding the cause of and cure for multiple sclerosis (MS). The Center focuses on patient-based research, bringing findings rapidly from the laboratory into clinical application to treat symptoms of MS and to halt or reverse damage caused by the disease. 


REGENERATE

In 2007, we started the process of obtaining FDA approval for a Phase I clinical trial. Finally, in August 2013, we received FDA approval to move ahead!
  • The objective of the Phase I trial is to test safety.
  • Data from the Phase I trial will lead to an improved strategy for Phase II
  • Positive outcomes of the trial may indicate the use of this therapy in other neurological diseases like ALS and Parkinson's Disease, cerebral palsy and spinal cord injuries.
Why Stem Cells? 
In pre-clincal, non-human experiments of our stem cell therapy, renewal, repair and regeneration of myelin occurred in the CNS after intrathecal (via spinal fluid, not intravenous) injection.

From our preclinical models, we know that stem cells injected into the spinal fluid can have significant benefit in terms of improved neurological symptoms.

 MS is characterized by brain inflammation, loss of myelin, damage to oligodendrocytes (the cells that make myelin), damage to neurons, and scar formation in the brain. As a result, nerve signals are not properly conducted, causing loss of neurological function. Stem cells are hypothesized to promote repair in MS by migrating to areas of demyelination, blocking damage-forming events, and enabling repair. 
Why Neural Stem Cells?

To learn more, click here





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theory: Deficiency in CD8 T cells in MS...

Wednesday, 4 June 2014

Deficiency in CD8 T cells in MS....a reason why EBV is a problem?

Can the Pender Hypothesis explain the mode of action of the emerging DMTs? #MSResearch #MSBlog

"The following paper from Professor Pender's group supports his theory that MS is due to a deficiency of CD8+ effector cells; these are the cells that kill virally infected cells and are responsible for tumour surveillance. His hypothesis is that a deficiency of these cells against EBV-infected B cells within the brain lets the EBV cells survive long-term and drive autoimmunity. If we can boost these cells to kill EBV infected cells then we can down regulate one arm of the autoimmune loop and switch off inflammation in the CNS."

"Against the Pender theory is the recent observation that MSers have a lower incidence of cancer than the  general population; if MSers had a long-standing deficiency of these CD8+ effector cells we would expect more tumours, not less. Another observation that goes against this theory would be the effectiveness of some of the newer DMTs that target the immune system; in particular natalizumab, fingolimod, alemtuzumab, anti-CD20 and daclizumab (anti-CD25) therapies. How do these treatments improve the deficiency of CD8+ effector cells in MSers? Natalizumab blocks their entry of CD8+ cells into the brain; we know this because of PML. CD8+ effector cells are needed to fight the JC-virus. Fingolimod, drastically reduces circulating numbers of lymphocytes; although has a greater effect on naive rather than memory cells. According the Pender theory would expect fingolimod to make MS worse. However, it may depend on  the balance between CD8+ and CD4+ cells entering the brain and spinal cord. Alemtuzumab depletes all cells and they reconstitute slowly over the next 12 months; T cells, which include the CD8+ population, take the longest to reconstitute and they never come back to normal. Anti-CD20 ablates peripheral B-cells and does not target CD8+ cells. In rheumatoid arthritis patients rituximab treatment does not alter CD4+, CD8+ or T-regulatory cells numbers. Some would argue that the response of MS to anti-CD20 would support the Pender hypothesis as it is working via EBV infected B-cells. This is a possibility, but we have no clear evidence that rituximab works on B cells within the central nervous system. Daclizumab increases natural killer cells (NK cells) and reduce T-regulatory and CD8+ cells; the effectiveness of daclizumab in MS would argue against the Pender hypothesis unless the NK cells are substituting for the CD8+ effector cells and killing the EBV-infected B cells within the central nervous system."

"As you can see immunology is very complex and can be very confusing; it is not helped by the difficult reproducing results across labs. What is evident that if you do come up with a causation hypothesis it needs to explain everything and I mean everything, the epidemiology, the clinical phenotypes, pathology and responses to treatment to mention a few. There can be no facts, little of big, left untouched. To quote Thomas Huxley 'the great tragedy of Science: the slaying of a beautiful hypothesis by an ugly fact.'"








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Tuesday, June 3, 2014

Video Recordings of our May 20th MS program in Miami


CLICK the IMAGE(s)



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Brian Steingo, MD
https://www.youtube.com/watch?v=vAw5cc9kN9U
Neurology


and 


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Christopher Gomez, MD, FACS
https://www.youtube.com/watch?v=0qAPoKjIEF0
Urology



to View Our 

MAY 20th, 2014 

Educational Program Video Recordings

from Miami, Florida




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Some MS Patients Resist Physical Activity Boost

June 2, 2014

Multiple sclerosis (MS) patients who would benefit the most from an increase in physical activity were, unfortunately, those for whom an intervention designed to boost it was least effective, a researcher said here.
In a secondary analysis of data from an earlier, overall successful trial of an Internet-based exercise intervention, factors associated with the strongest responses included mild versus moderate disability, body weight in the normal range versus obesity, and relapsing-remitting versus progressive MS, according to Robert Motl, PhD, of the University of Illinois in Urbana-Champaign.
There is "value in modifying and refining interventions" to improve their chances of success in difficult populations, he suggested at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
Separately, another analysis of the same trial data indicated that, in the overall study sample, the improvements seen in measures of physical activity were accompanied by reductions in time spent sitting.
Continue



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Monday, June 2, 2014

New AAN Guideline: Complementary and Alternative Medicine in Multiple Sclerosis

Report of the Guideline Development Subcommittee of the American Academy of Neurology

  1. Pushpa Narayanaswami, MBBS, DM, FAAN
  1. Correspondence to American Academy of Neurology: guidelines@aan.com
  1. doi: 10.1212/WNL.0000000000000250Neurologyvol. 82 no. 12 1083-1092
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ABSTRACT

Objective: To develop evidence-based recommendations for complementary and alternative medicine (CAM) in multiple sclerosis (MS).
Methods: We searched the literature (1970–March 2011; March 2011−September 2013 MEDLINE search), classified articles, and linked recommendations to evidence.
Results and recommendations: Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown

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