Positive Results Announced from Phase 3 Trial of Fingolimod Pills in Relapsing MS

Sept 30, 2009

Novartis International AG announced today that oral FTY720 (fingolimod) was able to significantly reduce relapse rates and slow disability progression over two years in a large-scale, phase 3 trial involving 1,272 people with relapsing-remitting MS. According to a company press release, safety data confirmed a positive benefit-risk profile for the lower of two doses tested, and the company plans to submit applications to drug regulatory agencies for marketing approval of the potential therapy at the end of 2009.

Background: FTY720 binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, that have been implicated in causing nervous system damage in MS. The drug appears to induce immune cells to remain in lymph nodes, where they can do little harm, preventing them from migrating into the brain and spinal cord.

Positive results from an earlier phase 2 study led to several large-scale phase 3 trials. Initial positive results from the TRANSFORMS study, comparing two different doses of fingolimod with Avonex® (interferon beta-1a, Biogen Idec) over only one year were presented at the American Academy of Neurology meeting in spring 2009. Adverse side effects seen more often in the fingolimod treatment groups in this trial included temporary reductions in heart rate at the start of therapy, small increases in blood pressure, and a few cases of macular edema (swelling of the back of the eye). Two deaths from herpes infections occurred in the group taking the higher dose of fingolimod, and seven cases of localized skin cancer occurred in the fingolimod groups.

Continue reading by clicking here

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EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

• 
  
• Press Release
• Source: EMD Serono, Inc. - On Wednesday September 30, 2009

ROCKLAND, Mass., Sept. 30 /PRNewswire/ -- EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies.

"As a leader in the area of neurodegenerative diseases, we continue to focus on making a positive difference in the lives of people living with MS, and their families," said Fereydoun Firouz, President and CEO of EMD Serono, Inc. "If approved, short-course therapy with Cladribine Tablets could transform the way people approach their treatment options, and meet an unmet need as an oral, disease modifying drug available for MS. We look forward to working with the FDA during the course of the regulatory process."

Continue reading this article on oral cladribine by clicking here

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Patient-Targeted Messaging for Emerging Multiple Sclerosis Agents Needs to Highlight Efficacy and Preservation of Quality of Life

PRNEWSWIRE

WALTHAM, Mass., Sept. 30 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that patient-targeted messaging for emerging multiple sclerosis oral agents will need to provide high-level information regarding the efficacy and preservation of quality of life and forego catchy and/or short taglines highlighting oral dosing. The knowledgeable multiple sclerosis patient population is likely to already be informed about oral dosing and will want information regarding efficacy and safety so that they can readily compare these new agents to the efficacy and safety of currently available agents.

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Novartis MS Pill Works, May Launch As Soon As '10

Sept 30, 2009

(RTTNews) - Novartis AG (NVS) said Wednesday that initial results from a late-stage study showed that treatment with oral FTY720 significantly reduced relapses and disability progression in patients with multiple sclerosis compared to placebo. The company noted that comprehensive analyses of the data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2010.

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MSRC Message Boards and Chat Room

Stuart recommends the MSRC website for chatting with your MS peers

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Are you one of the ever growing numbers of people taking advantage of the personal interaction with other MSers in the MSRC’s MS Message Boards and Chat Room?

If not, you are missing out on a wonderful way to make new friends. You can chat not only about MS topics, current news, music and humour but anything else you'd like to discuss.

Many people come to both the message boards and the chat room for advice on specific MS issues and then stay on after receiving the best advice and support they could have wished for.

If you would like to get more involved with other MSers in a friendly, safe environment, then please come and join us; we would be very pleased to see you in either the Message Boards, or the Chat Room, or ideally, both.

The message boards are open to all and are easy to use whatever your physical capabilities and computer skills. There are a range of boards, some dealing with MS issues, Personal MS Journeys etc. and others are more light-hearted. Over the Garden Fence is a very popular Forum where banter, discussions on current news topics etc. are discussed and if you are in need of a “lift” check out the Humour Board, where a smile is guaranteed. To visit the message boards please click here: http://msrcsharing.yuku.com/directory.

If more 'immediate' talk is your thing then come join one of the regular, moderated Chat Room sessions which, at present, take place three times a week on a Tuesday Morning 10am – 12noon, Wednesday Evenings 8pm – 10pm and Thursday Afternoons 2pm – 4pm. You can access the Chat Room via the MSRC Homepage http://www.msrc.co.uk.

The MSRC Chat Room is open 24 hours a day but at other times the room is not moderated; however, you can arrange to meet your friends for a chat at anytime.

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MS Trial Alert: Study of Oral Teriflunomide (HMR1726) Recruiting People at High Risk for MS Worldwide

September 29, 2009

Summary: Investigators worldwide are recruiting people at high risk for multiple sclerosis (MS) for a study comparing two doses of oral HMR1726 (teriflunomide), an immune system-modulating agent, and inactive placebo. People at high risk for MS are those who experience a clinically isolated syndrome (CIS, a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and brain magnetic resonance imaging findings suggestive of MS. The study is sponsored by Sanofi-Aventis.

Rationale: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is an agent that may decrease immune system activity in MS. Other studies of teriflunomide in MS are ongoing.

Eligibility and Details: People eligible for participation include individuals 18-55 years of age who experience a clinically isolated syndrome (a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and magnetic resonance imaging findings suggestive of MS.

Participants will be randomly assigned to receive 7 mg teriflunomide, 14 mg or placebo once daily for 108 weeks (about 2 years). The main outcome measure of the study is to determine whether the study drug reduces the time to conversion to clinically definite MS significantly more than placebo. Other measures will be followed including functioning of patients and changes in brain MRI scanning.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit http://www.thetopicstudy.com/.

source: National MS Society

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Stem Cell and Gene Therapeutic Strategies for the Treatment of Multiple Sclerosis

Siatskas C, Bernard CC.

Multiple Sclerosis Research Group, Monash Immunology and Stem Cell Laboratories, Monash University, Clayton, Victoria, 3800, Australia. christopher.siatskas@med.monash.edu.au.

Multiple sclerosis is a disease of the central nervous system that predmoninantly affects young adults. The pathogenic mechanisms are complex, however numerous studies indicate that the disease is initiated by an autoimmune attack on protein targets present in the central nervous system.

Given that a dysfunctional immune system perpetuates the pathophysiological mechanisms that characterize this inflammatory disorder, several therapeutic approaches that target immune cells or their secreted mediators have been generated and are currently used clinically.

Although these strategies have been partially beneficial to a proportion of patients, current therapies are not particularly effective at preventing disease progression. As such there is a large and unmet need for the development of more effective treatments.

Owing to a number of promising results obtained in mouse models of multiple sclerosis, cell therapies implementing hematopoietic, mesenchymal and neural stem cells may provide practical vehicles for in situ immunomodulation, neuroprotection and regeneration.

In concert with these approaches, gene therapy strategies are being investigated to restore antigen-specific tolerance or to deliver anti-inflammatory molecules. Furthermore targeted delivery of glial or neurotropic factors, which counteract the activity of inhibitory molecules within the neurodegenerative component of the lesion, is also being pursued. It is conceivable that these experimental approaches alone, or in combination with emerging and current treatments, may establish a rational protocol for the treatment of multiple sclerosis and potentially other autoimmune disorders.

PMID: 19747118 [PubMed - as supplied by publisher]

For related articles, click here

Analyses of cerebrospinal fluid in the diagnosis and monitoring of multiple sclerosis

Awad A, Hemmer B, Hartung HP, Kieseier B, Bennett JL, Stuve O.

Department of Neurology, University of Texas Southwestern Medical Center at Dallas, TX, USA.

The laboratory evaluation of cerebrospinal fluid (CSF) has been routinely employed as a diagnostic test in the diagnosis of neuroimmunological disorders such as multiple sclerosis (MS). Recently, CSF analyses in MS have garnered renewed interest as a tool for monitoring disease activity and prognosis. With the identification of patients that are very early in their disease course, namely patients with a radiologically isolated (RIS) or a clinically isolated syndrome (CIS), the true value of these evaluations has yet to be fully explored. Ultimately, the hope is that biomarkers within this compartment will be identified that will identify etiologic factors of MS and other inflammatory disorders of the central nervous system. In this review we discuss the history of CSF diagnostic tests and the most recent methodological advances. We also outline the potentially important diagnostic role and possible limitations of these tests.

PMID: 19782408 [PubMed - as supplied by publisher]

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P2Y12 Receptor Protein in Cortical Gray Matter Lesions in Multiple Sclerosis

Amadio S, Montilli C, Magliozzi R, Bernardi G, Reynolds R, Volonté C.

Santa Lucia Foundation, 00143 Rome, Italy.

Although Multiple Sclerosis (MS) is regarded as a white matter disease, the incidence of demyelination and axonal injury is prominent also in gray matter. In MS, extracellular adenosine triphosphate (ATP) is an important mediator of central nervous system pathology via its ability to cause oligodendrocyte excitotoxicity. We have analyzed the distribution pattern of all ionotropic P2X and metabotropic P2Y receptors for ATP in postmortem samples of the cerebral cortex from healthy human subjects as well as MS patients. We focus particularly on the P2Y(12) subtype that is highly enriched in oligodendrocytes. We correlate the expression of this receptor to the extent of gray matter demyelination and pathological alterations occurring during secondary progressive MS.

Using triple immunofluorescence and confocal analysis, we show that in sections of cerebral cortex from postmortem MS brains, the P2Y(12) protein is present in myelin and interlaminar astrocytes but absent from protoplasmic astrocytes residing in the deeper cortical layers, from microglia/macrophages, and from intact demyelinated axons. We report that a decreased P2Y(12) receptor immunoreactivity in proximity to the lesions is directly correlated with the extent of demyelination found in all types of gray matter cortical plaques (I-III) and subcortical white matter. Our study provides further insights into the pathogenetic features of MS and suggests that the loss of purinergic P2Y(12) receptors might be detrimental to tissue integrity.

PMID: 19783848 [PubMed - as supplied by publisher]

Source : pubmed
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Free Educational Symposium Looks to the Future of MS

A free educational symposium, “MS 2009: Vision for the Next Decade” will be offered from 8 a.m. to 1 p.m. Nov. 15^th at the Hilton New York in New York City.

The symposium is being presented by the International Multiple Sclerosis Management Practice and Multiple Sclerosis Research Center of New York (MSRCNY). Topics include current and future treatment for the newly diagnosed and for progressive MS, coping with MS, naturopathic medicine, physical therapy for MS, and research at MSRCNY. Also included is a review of patient profiles with a question and answer session.

This symposium is open to anyone interested in learning more about MS research and treatments.

To register go to www.imsmp.org/register.asp or call: (646) 557-3919.

For questions: symposium2009@imsmp.org. Seating is limited.

source: MSFYi e-newsletter from the MS Foundation
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Using Acetaminophen with Caution

Source: MS Foundation Newsletter (MSFYi)

September was National Pain Awareness Month, a time to focus both on pain and pain-relief. One of the most popular over-the-counter pain relievers, acetaminophen, has drawn the FDA’s attention recently due to the problem of liver injury related to the use of acetaminophen in both over-the-counter and prescription products. When used as directed on the label, acetaminophen is generally considered safe, but liver damage can occur if more than the recommended dose is taken.

As an ingredient in prescription medications, it may be abbreviated as “APAP.” And in other countries, acetaminophen can have a different name. In Great Britain, for example, it is called paracetamol.

To lower your risk of damage, the FDA recommends you do the following: Follow the dosing directions and never take more than directed because even a small amount more than directed can cause liver damage. Don’t take it for more days than directed. Don’t take more than one medicine that contains acetaminophen at a time.

Talk to you doctor before taking acetaminophen if you drink three or more drinks of alcohol every day, or have liver disease. Also, if you take the blood thinner warfarin you should talk with your doctor first, because taking warfarin and acetaminophen together may raise your risk of bleeding.

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Genetic Clues May Help Predict MS Outcomes

Source: MSFYi newsletter

Among the unknown factors about MS is why the disease differs in severity, symptoms and progression from person to person. Results of a recent study conducted by the Mayo Clinic indicate that at least some predictions of disease course may lie in a small number of strong genetic determinants.

Researchers discovered that two genes in mice were associated with good central nervous system repair, giving them hope for developing more effective therapies for people with MS and for anticipating how the body will respond to the disease.

The study used two different strains of mice with a chronic, progressive, MS-like disease. One strain progressed to paralysis and death. The other underwent the initial damage phase of the disease and then spontaneously repaired the damage to the central nervous system, retaining most neurological function. Using genetic mapping techniques for mice, researchers mapped two strong genetic determinants of good disease outcome.

“It’s possible that the identification of these genes may provide the first important clues as to why some patients with MS do well, while others do not,” says Allan Bieber, Ph.D, the Mayo Clinic neuroscientist who authored the study. “The genetic data indicates that good central nervous system repair results from stimulations of one genetic pathway and inhibition of another genetic pathway. While we’re still in the early stages of research, it could eventually lead to the development of useful therapies that stimulate or inhibit these genetic pathways in patients with MS.”

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Why I'm thankful for multiple sclerosis

Written by: Lorrie Jorgensen

From Monday's Globe and Mail - Monday, Sep. 28, 2009

I wish someone would hurt me. Not kill-me kind of hurt, but enough to damage me visibly. They could run me down with their car or batter my legs with a baseball bat. That would work.

I don't normally think this way but on my tired days when I'm really wiped I tend to get dramatic and over the top with self-pity. I have multiple sclerosis and one of my biggest challenges is battling continuously to overcome the debilitating fatigue that accompanies the disease. Like a junkie, I have worked my way through the available medications, but nothing has worked for long.

The medical community does not know what causes MS but there are theories. There is an increased prevalence of the disease in northern European countries, leading to discussions about environment, lack of sunshine and vitamin D. There is also talk about predispositions, viruses and genetics. Being female almost tripled my odds of getting the disease. There is no cure.

Click here to continue to read Lorrie's Story

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Writer (with MS) to donate half of her net proceeds to the MS Society of Canada for MS research

About the Writer, Barbara Dickson:

Diagnosed with multiple sclerosis in 1992, Barbara refused to succumb to illness without a fearless fight. Forced to retire from her career as an IT software analyst, she quickly re-discovered her love of writing.

Now a multi-published inspirational author and public speaker, Barbara strives to instill hope in her audiences, especially when life has other plans. Barbara’s determined to touch the world, one heart at a time.

Half of all net proceeds from the sale of Mountains for Maddi will be donated to MS research, and is supported by the MS Society of Canada.

Readers can reach Barbara via her website at: www.barbaradickson.ca

or by e-mail at: contact@barbaradickson.ca

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About: Mountains for Maddi:

Maddi Madigan, while on vacation, careens into Dr. Gregory Connor on a snowy ski slope. Entangled with Greg and buried in snow, her heart skitters, almost as far as her ski poles.

She soaks up the magnificent Rocky Mountain atmosphere over the next few days while avoiding an entanglement of another kind—romance. She bears the scars from a broken engagement, and is convinced men and a diagnosis of multiple sclerosis don’t mix; at least that’s what her head tells her.

Too bad her heart has other plans. Greg, utterly smitten, pursues Maddi the same way he works—hard. When she lingers just beyond his romantic grasp, he rallies with dogged determination.

Can Maddi make it through the week without her heart ending up in a puddle of slush at Greg’s feet? How hard should she try?

Could Greg truly offer hope for a Happily Ever After?

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Learn how to get your copy of this romantic novel by clicking the link found above to reach Barbara

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"Episodes" The story of an MSer

I have known Charles for a few years and thought you may want to know of his book called:

Episodes: The story of an MSer and of MSB's Podcast

by Charles-A. Rovira

To get your copy, click here

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AARP News: Stay Healthy & Happy Longer!

If 50 or better: Join AARP and Blue Zones on the path to longevity.

Also, get the chance to win free walking poles.

Plus, discover how strengthening your social circle and spirituality may help you live better and longer…

Click here to continue »

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Have something to share with others? If so, please use the post comment link found below. Your name and email address would be appreciated but is not necessary unless you want a response from others. Thank You
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MS patient's climb to success inspires Women on the Move

By Joanne Davidson
The Denver Post

POSTED: 09/25/2009 01:00:00 AM MDT

Women on the Move chairwomanFrancie Morgan, left, with Colorado chapter president Carrie Nolan and speaker Wendy Booker. (Photo by Joanne Davidson, The Denver Post )

The lyrics to a popular oldieAin't no mountain high enough — certainly applies to Wendy Booker, who didn't let multiple sclerosis stand in the way of completing her Seven Summits tour.

Booker is the first person living with MS to climb the highest peaks on each continent, and she was in Denver last week to share her success with the 550 who attended Women on the Move, a luncheon benefiting the Colorado chapter of the National Multiple Sclerosis Society.

Continue to read, by clicking here

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Paralyzed Rats Walk Again

After repeated requests from several with regards to this article, I am now posting a link for you to read more on:

A three-pronged approach to treating spinal cord injuries allowed paralyzed rats to walk without receiving signals from the brain, scientists report.

Click this link to read: http://news.yahoo.com/s/hsn/20090920/hl_hsn/paralyzedratswalkagain

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Incidence of multiple scleroris in Scotland is twice the rate of MS in the UK

Information provided by Terence in Spain:

You may already be aware that the incidence of multiple scleroris in Scotland is twice the rate of MS in the UK. Northern Ireland comes a close second.

.--Country--	--PwMS--	per 100k
Scotland	10,500	190.0
N.Ireland	3,349	168.2
England & Wales	100,000	110.0

As "The Independent" a UK newspaper put it in 1999:

"People living in Scotland who also have a Scottish name are more
than twice as likely to develop multiple sclerosis .... than the English."

My e-friend in the USA, Erin Teso, and myself are trying to raise awareness of this fact, not the least because Scottish emigrants may be responsible for spreading the disease to the USA and Australia. Read my webpages at:

http://www.aspects.net/~janus/ScottishDisease.htm
http://www.aspects.net/~janus/FamousMS.htm

Please help spread the word. Great indeed is the power of the Internet!

--- Terence Wilson Cortijo El Almendro, Motril 18600, Granada, España. 

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Have something to share with others? If so, please use the post comment link found below. Your name and email address would be appreciated but is not necessary unless you want a response from others. Thank You
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The Unofficial Tysabri Survey can be found at...

Today is : September 24, 2009

The un-official Tysabri Survey that began just over a week ago and continues to seek responses, can be found at this link: http://wwwmsviewsandrelatednews.blogspot.com/2009/09/unofficial-survey-for-tysabri-users.html

THANK YOU

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MS Views and News has grown to reach people from all over the world

Our Mission:

MS Views and News is dedicated to the global collection and distribution of current information concerning Multiple Sclerosis. In collaboration with other organizations, MS Views and News uses state-of-the-art communication channels to provide information for those affected by, or interested in MS.

Dear Friends

It is with great satisfaction that MS Views and News has grown to reach people from all over the world. This unique organization provides information from numerous resources and organizations to link and educate the MS community.

As you are probably aware of, in order to continue to provide these services we can't do it alone. This is where you can help now and in the future.

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With Sincere Gratitude,

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