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Saturday, June 1, 2013

Excellent Results For another hopeful MS Drug "Plegridy" -

Biogen Idec announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY™ (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS).
“This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease”

This regulatory submission was based on the results from the first year of the two-year global Phase 3 ADVANCE study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.

"This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease," said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. "We believe that based on the efficacy and safety PLEGRIDY has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option."

In addition to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for PLEGRIDY to the European Medicines Agency (EMA) in the coming weeks.

Biogen Idec has been the leader in the development of MS therapies for three decades and its robust treatment portfolio and development pipeline provides options that may help manage the disease from its earliest signs through its later stages.

The company anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months.

Source Biogen Idec

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Genetically engineered immune cells appear to promote healing in mice infected with MS-like disease

June 1, 2013

Genetically engineered immune cells seem to promote healing in mice infected with a neurological disease similar to multiple sclerosis (MS), cleaning up lesions and allowing the mice to regain use of their legs and tails.

The new finding, by a team of University of Wisconsin School of Medicine and Public Health researchers, suggests that immune cells could be engineered to create a new type of treatment for people with MS.

Currently, there are few good medications for MS, an autoimmune inflammatory disease that affects some 400,000 people in the United States, and none that reverse progress of the disease.

Dr. Michael Carrithers, assistant professor of neurology, led a team that created a specially designed macrophage - an immune cell whose name means "big eater."Macrophages rush to the site of an injury or infection, to destroy bacteria and viruses and clear away damaged tissue. The research team added a human gene to the mouse immune cell, creating a macrophage that expressed a sodium channel called NaVI.5, which seems to enhance the cell's immune response.

But because macrophages can also be part of the autoimmune response that damages the protective covering (myelin) of the nerves in people with MS, scientists weren't sure whether the NaV1.5 macrophages would help or make the disease worse.

When the mice developed experimental autoimmune encephalomyelitis - the mouse version of MS -- they found that the NaV1.5 macrophages sought out the lesions caused by the disease and promoted recovery.

"This finding was unexpected because we weren't sure how much damage they would do, versus how much cleaning up they would do,'' Carrithers says. "Some people thought the mice would get more ill, but we found that it protected them and they either had no disease or a very mild case."

In follow-up experiments, regular mice that do not express the human gene were treated with the NaV1.5 macrophages after the onset of symptoms, which include weakness of the back and front limbs. The majority of these mice developed complete paralysis of their hindlimbs. Almost all of the mice that were treated with the Na1.5 macrophages regained the ability to walk. Mice treated with placebo solution or regular mouse macrophages that did not have NaV1.5 did not show any recovery or became more ill. In treated mice, the research team also found the NaV1.5 macrophages at the site of the lesions, and found smaller lesions and less damaged tissue in the treated mice.

Because the NaV1.5 variation is present in human immune cells, Carrithers says, "The questions are, 'Why are these repair mechanisms deficient in patients with MS and what can we do to enhance them?' '' He says the long-range goal is to develop the NaV1.5 enhanced macrophages as a treatment for people with MS.

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I gotta new way to walk (walk walk)* -- an MS Patient's story

June 1, 2013

Last week I took home my brand-new pair of Walk-On® foot braces- though I prefer the more fashionable phrasing, “assistive foot accessory” :)  It all started about 6 months ago when I signed up for physical therapy at Kessler Institute for Rehab here in NJ. It didn’t take long to feel improvements that reached well beyond the muscle-strengthening, balance-increasing, core-engaging milestones. Just taking this pro-active step made me feel better. Not to mention the positive influence of having someone (a.k.a Liz) cheering me on for even the slightest improvements. We should all have someone who plays that role in life, dontcha think?
In addition to this twice a week cheer-lead gig, I have been part of the Kessler’s Wellness Program for PWMS and I can’t begin to tell you how it’s changed my life. It’s funny how the ability to learn is so contingent on timing and circumstance. (Considering my MS SoftServe mission you’d think I’d know that by now!)
The Cheerleader and The Cheered!
The Cheerleader (Liz Woods)  and The Cheered (me)!
So it was at one of these sessions that a physical therapist (we’ll call him Joe, which is in fact his name!) talked to us about balance strategies. It was basic stuff that I hadn’t considered; like how to stabilize oneself by pressing the outsides of your feet to the ground. Smart right? Then he spoke about the assistive devices.  In addition to balance and dizziness issues, I have intermittent bi-lateral foot-drop. i.e. I pick up my foot, my toes drop and then I do. It happens unpredictably on both sides and gets worse as I fatigue. This reality makes for some serious apprehension with every step I take. And even with the added insurance of a walking stick- I continue to fall. And every fall is a fall too many. (Especially when it’s in front of my daughter- that just sucks!) As far as assistive devices, I thought I knew what was out there. I had heard of the commonly used  device – the one that sends an electrical signal down your leg prompting your foot to lift at just the right moment. I figured if things should get worse I know it’s out there. And after all, my foot-drop is intermittent and occurs both of my feet. What was I going to do? Wear a brace on both feet?
Yes… apparently I’m doing just that!  When I learned about the variety of braces- each offering different degrees of assistance and all different degrees of unassuming, I realized I need to revisit this. So I did at my next therapy session. Liz sized me up, made a recommendation and sent me off to the brace clinic- also at Kessler.
While I waited for my appointment, I continued to doubt myself. Is this something I really needI mean, I don’t have that bad a case of foot-drop… Well that feeling lasted for all of 10 minutes abruptly ending with my pre- and post- brace walk demo. As soon as I heard all the oohs and ahhs from the cluster of experts watching me from behind, I knew that this is going to be a huge improvement I my life. I hadn’t thought much about my apprehension in walking and how much energy I wasted on making sure I won’t fall.
My brand new assistive foot accessories!
My brand new assistive foot accessories!
When I took those babies home I look moved like a different person. I found an audience in my family ooh-ing and ahh-ing with every sashay & shantay.  And while I was concerned about getting caught up in the feeling of “OMG, I have to wear these things to walk well?” I am completely distracted by the whole “OMG I can walk so well with these things.”
And they are oh so subtle. One might not notice unless that one happens to be on the ground and spots the carbonate strip running down the back of my calves. And who does that!?! :)
After 25 years of living with this totally-unpredictable, completely-incurable, constantly-changing disease I thought I had a pretty good handle on managing it. But managing one’s MS is not unlike a cat chasing the red laser pointer dot that disappears just as the paw is closing in on it. Apparently I’m gaining on it!
*If you don’t have a person in the house who has watched Sesame Street in the last 1o years then you probably aren't singing this title like I am.  And because I find the tune oh- so-necessary to properly express my enthusiasm watch this.

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Vitamin D Benefit in MS: Molecular, Genetic Evidence

Pauline Anderson
May 31, 2013

Orlando, Florida — Researchers have uncovered molecular and genetic evidence that vitamin D benefits patients with multiple sclerosis (MS) who are receiving therapy.
The analysis showed that genes associated with increased vitamin D levels — 25-hydroxyvitamin D or 25(OH)D — and with interferon β-1b are also associated with a decrease in gadolinium-enhancing lesion (Gd+ lesion) counts.
While other studies have shown that vitamin D may reduce the risk for MS and may even be important in the progression of the disease, that research couldn't "tease out" the molecular or genetic mechanisms behind this effect, said study author Kassandra L. Munger, ScD, research associate, Harvard School of Public Health, Boston, Massachusetts.
The new analysis, reported here at the 5th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS), used data from theBEtaferon (BEtaseron) in Newly Emerging MS For Initial Treatment (BENEFIT) study that examined the safety and efficacy of early interferon β-1b treatment in 468 patients with clinically isolated syndrome.
Patients were randomly assigned to interferon β-1b (250 μg subcutaneously) every other day (early treatment) or to placebo (delayed treatment) and followed for 2 years for the development of MS.
Patients underwent MRI and had blood samples taken at baseline and at 2, 3, 12, and 24 months.
The main results of the BENEFIT study showed significant improvements in clinical and radiologic outcomes in patients who received early treatment compared with those who had delayed treatment with interferon β-1b after a follow-up of up to 8.7 years.
In this analysis, the researchers used samples from this population to assess levels of 25(OH)D and measured gene expression.
They observed a seasonal fluctuation in vitamin D levels that "mirrored" fluctuations in Gd+ lesion counts, although this could be "purely correlational," said Dr. Munger.
Looking at quintiles of vitamin D levels, the researchers noted that the highest vitamin levels were associated with lower lesion counts. "There is about a 57% reduced risk of new gadolinium lesions with every 50 nmol/liter increase in vitamin D," said Dr. Munger.
When the researchers included interferon β-1b, which is known to reduce lesions, into the model, the study found that both vitamin D levels (= .0001) and interferon (P < .0001) were statistically significantly protective against the development of new lesions.
"This suggests that vitamin D is contributing something," said Dr. Munger.
But she and her colleagues also wanted to see whether genes play a role. The gene expression analysis of whole blood samples showed there were 63 genes associated with vitamin D, 770 genes associated with interferon β-1b, and more than 5000 genes associated with the Gd+ lesions.
It also showed a fair amount of overlap between all 3 gene sets, suggesting shared pathways. Further, a functional classification showed that these overlapping genes tend to fall into categories associated with immune response, suggesting a defense response to bacteria.
Read More - HERE
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Decisions to change multiple sclerosis treatments soon after starting them appear to be driven more by MRI findings

By John Gever, Deputy Managing Editor, MedPage Today
Published: May 31, 2013
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner



ORLANDO -- Decisions to change multiple sclerosis treatments soon after starting them appear to be driven more by MRI findings of increasing disease activity than worsened clinical symptoms, a researcher said here.
In a retrospective analysis of 606 patients showing suboptimal responses to an initial disease-modifying therapy, the factor showing the strongest association with a change in treatment was increased disease activity seen in MRI scans (odds ratio 6.3 compared with a single relapse alone, 95% CI 3.1-12.9), reported Barbara Teter, PhD, MPH, of the State University of New York at Buffalo.
Oddly, though, the patients least likely to change treatments were those showing relapses plus either worsened disability or increased MRI lesions, according to Teter. She and her colleagues had no firm explanation for this finding, but their hypothesis is that such patients are psychologically resistant to seeking other treatments, she told MedPage Today.
Other factors associated with increased or decreased likelihood of changing treatments after a suboptimal initial response included multiple relapses, disability progression, patient age, and time elapsed from diagnosis to initiation of disease-modifying treatment.
Teter and colleagues reviewed data from 1,448 patients in a New York state registry of MS patients from 1996 to 2009, comprising 14 MS clinics and neurology practices. Records were complete for 606 patients who had started treatment with either interferon-beta (Rebif, Avonex, Betaseron) or glatiramer acetate (Copaxone) and subsequently suffered an MS "event."
An event was defined as a clinical relapse, disability worsening as measured on the Expanded Disability Status Score (EDSS) system, increases in MRI lesion volumes or counts, or any combination of these noted at a single clinic visit. Patients who changed treatments after a second MS event separated in time from the first were not included in the analysis.
Patient demographics and clinical characteristics were reflective of the general MS population starting on disease-modifying drugs during the study period. About 75% were women, they were in their early 30s on average at symptom onset, and they started their first disease-modifying treatment a mean of about 8 years later. Mean EDSS score at initiation of disease-modifying therapy was 2.3 (SD 1.6).
Of the 606 patients in the analysis, 214 changed to another disease-modifying treatment within 6 months of an event, whereas the other 392 remained on their initial therapy. Switchers changed treatments a mean of 3.4 years (SD 2.7) after starting the first therapy.
The most common event in the overall sample was EDSS worsening alone, seen in 25% of patients, followed by relapse alone (22%), MRI worsening alone (16%), and relapse combined with EDSS worsening (16%). Other combinations were seen in less than 10% of patients.
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Goat Serum Extract Stops Progressive MS

By John Gever, Deputy Managing Editor, MedPage Today
Published: May 31, 2013
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania
 
ORLANDO -- A controversial product derived from goat blood appeared to benefit patients with secondary progressive multiple sclerosis in an open-label study, researchers said here.
Among 140 British patients receiving up to 3 years of treatment with the proprietary extract, called AIMSPRO, in clinical practice, 100 showed improvement in at least two separate areas of MS-related symptomatology, according to Christopher E.G. Moore, MSc, MBBS, of Queen Alexandra Hospital in Portsmouth, England.
Although Moore and colleagues did not calculate Expanded Disability Status Score (EDSS) values for patients in the study, the clinician-estimated improvements in two or more symptom areas ought to translate to decreases of at least 0.5 points in EDSS scores, they argued.
The study results were presented at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
AIMSPRO includes a cocktail of immunoglobulins targeting human proteins, including proinflammatory human leukocyte antigens, according to the product's developer, Daval International Ltd. of Eastbourne, England. It also upregulates anti-inflammatory cytokine, the firm said. The drug is administered by subcutaneous injection in doses of 4.5 mg at individually determined intervals, most often twice weekly.
It was originally developed as a potential anti-HIV therapy, but Daval later shifted emphasis to other conditions including MS as well as systemic sclerosis and amyotrophic lateral sclerosis. Although AIMSPRO has never been approved anywhere for marketing, the firm is allowed to sell the drug in Great Britain under the country's compassionate-use regulations.


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MS Severity Drives Patients to Vein Surgery

Provided by: Cherie C. Binns RN BS MSCN


This article was released from the CMSC Conference in Orlando today.  On Wednesday afternoon, I attended a preliminary talk on CCSVI that looked briefly at all of the major studies on CCSVI since Zamboni brought the condition to world-wide attention in 2009.  In most of the studies done to date, the control subjects (those without MS) showed this condition more often than people with MS.  The biggest finding in most of the studies was that the Liberation Procedure rarely worked for longer than 2 weeks before the vein closed again.   Several participants in the studies had the procedure repeated as many as 3-4 times with none showing long term or permanent improvement.  Older patients with greater degrees of progression of disability were requesting this procedure more than any other group of people with MS.  Studies are continuing and stent design is being studied to see if a more effective stent might be developed.

Click http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/39493 for the full story


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‘Marijuana halts brain damage’

Information provided by a Friend of Stu's Views & MS News/ MS Views and News:
Shub Sabharwal

PTI | Jun 1, 2013,


WASHINGTON: Extremely low doses of THC —the psychoactive component of marijuana — protects the brain from long-term cognitive damage in case of injury from hypoxia (lack of oxygen ), seizures, or toxic drugs, a study has claimed.

Medical cannabis is often used by sufferers of chronic ailments, including cancer and post-traumatic stress disorder, to combat pain, insomnia , lack of appetite, and other symptoms.

Now, professor Yosef Sarne of Tel Aviv Universityfound the drug has neuroprotective qualities as well.

Previous studies focused on injecting high doses of THC within a very short time frame — approximately 30 minutes — before or after injury.

Sarne's current research, published in the journals Behavioural Brain Research and Experimental Brain Research, demonstrates that even extremely low doses of THC — around 1,000 to 10,000 times less than that in a conventional marijuana cigarette — administered over a wide window of 1 to 7 days before or 1 to 3 days after injury can jump start biochemical processes which protect brain cells and preserve cognitive function over time.

This treatment, especially in light of the long time frame for administration and the low dosage, could be applicable to many casesof brain injury and be safer over time, Sarne said.

While performing experiments on the biology of cannabis , researchers found that low doses of the drug had a big impact on cell signalling , preventing cell death and promoting growth factors. The use of THC can prevent long-term cognitive damage that results from brain injury, the researchers concluded after studies.

Article Source: The Times of India

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Are You Ready for an MS Relapse?



Are you relapse-ready? Find out now at rethinkMSrelapses.com.
rethinkMSrelapses.com is a website designed to help you become relapse-ready.


At rethinkMSrelapses.com, you can:
  • Learn how to identify an MS relapse
  • Explore treatment options
  • Plan ahead for a relapse

Go Inside an MS Relapse to learn the science behind the symptoms

Track your symptoms using My Relapse Report

Create your Relapse Action Plan to help you prepare for a relapse

P.S. Don’t forget to sign up for an educational event in your area and share rethinkMSrelapses.com with your family, friends, and MS community!


Questcor® is a registered trademark of Questcor Pharmaceuticals, Inc.
©2013 Questcor Pharmaceuticals, Inc. PM-923-00 05/13







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Friday, May 31, 2013

Anti-anxiety Drug Reduces Severity of MS Model in Mice

Working with models of MS in mice, UC Davis scientists have detected a novel molecular target for the design of drugs that they say could be safer and more effective than current FDA-approved medications against MS.

The findings of the research study, published online in the journal EMBO Molecular Medicine, could have therapeutic applications for MS as well as all disorders associated with loss of white matter, which is the brain tissue that carries information between nerve cells in the brain and the spinal cord.

The target, a protein referred to as mitochondrial translocator protein (TSPO), had been previously identified but not linked to MS. The mitrochronical TSPO is located on the outer surface of mitochondria, cellular structures that supply energy to the cells. Damage to the fatty coating, or myelin, slows the transmission of the nerve signals that enable body movement as well as sensory and cognitive functioning.

The scientists identified mitochondrial TSPO as a potential therapeutic target when mice that had symptoms of MS improved after being treated with the anti-anxiety drug etifoxine, which interacts with mitochondrial TSPO. When etifoxine, a drug clinically available in Europe, was administered to the MS mice before they had clinical signs of disease, the severity of the disease was reduced when compared to the untreated lab animals. When treated at the peak of disease severity, the animals' MS symptoms improved.

"Etifoxine has a novel protective effect against the loss of the sheath that insulates the nerve fibers that transmit the signals from brain cells," said Wenbin Deng, principal investigator of the study and associate professor of biochemistry and molecular medicine at UC Davis.

"Our discovery of etifoxine's effects on an MS animal model suggests that mitochondrial TSPO represents a potential therapeutic target for MS drug development," said Deng.

"Drugs designed to more precisely bind to mitochondrial TSPO may help repair the myelin sheath of MS patients and thereby even help restore the transmission of signals in the central nervous system that enable normal motor, sensory and cognitive functions," he said.


Current FDA-approved therapies do not repair the damage of immune attacks on the myelin sheath.

Source: MSFYi News
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Wednesday, May 29, 2013

Progress in MS to Highlight Joint Meeting

Stuart and his team from MS Views and News, are displaying at this years' meetings:


ORLANDO -- Studies to be presented at a joint meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) here later this week will demonstrate yet again why MS is one of the most dynamic fields of medicine.
"The availability of medications with different mechanisms of action and risk-benefit profiles, understanding basic disease pathology, dealing with personal challenges due to chronic disease, and the consequences of the rising healthcare costs are rapidly evolving issues in MS," according to CMSC President Susan Bennett, PT, DPT, EdD, and ACTRIMS President Paul O'Connor, MD, MSc.
With 35 oral research presentations and nearly 150 posters scheduled at the meeting -- in addition to dozens of workshops, courses, and symposia -- the meeting "will provide attendees with information about the immunology, genetics, biomarkers, epidemiology, and pathophysiology of the disease," added June Halper, MSCN, APN-C, CMSC's executive director.



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Novartis launches new campaign to raise awareness of multiple sclerosis

Basel
Wednesday, May 29, 2013, 14:00 Hrs  [IST]
Novartis is joining the global multiple sclerosis (MS) community in celebration of World MS Day by launching a new campaign and participating in initiatives that encourage information and experience exchange around MS. Novartis is committed to supporting the MS community through these initiatives, in addition to delivering and researching innovative treatments to help address the high unmet medical needs of people with MS at every stage of the disease.

World MS Day was created by the Multiple Sclerosis International Foundation (MSIF) in 2009 to raise global awareness of MS and its impact on approximately 2.5 million people with MS around the world. This year's World MS Day campaign focuses on young people; MS is normally diagnosed between the ages of 20 and 40, but can also occur earlier in life. This diagnosis can be devastating at a time when young people may be starting careers and making plans for the future.


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New Memoir by Singer/Songwriter Kristie Salerno Kent Follows Her Journey as a Multiple Sclerosis Patient Advocate

“Dreams,” sponsored by Acorda Therapeutics, shares a story of overcoming denial, fighting multiple sclerosis and achieving lifelong dreams.
ARDSLEY, N.Y.--(BUSINESS WIRE)--May. 29, 2013-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced publication of the breakthrough memoir “DreamsMy Journey with Multiple Sclerosis,” available through a free download at www.DreamsTheEBook.com. “Dreams” is the story of Kristie Salerno Kent, who faced the challenges of multiple sclerosis (MS) and went on to become a national advocate for people living with MS and their partners, as well as building a successful career as a singer-songwriter. This is the intimate story of how one woman triumphed over fear and denial through her passion for music and her decision to never give up hope.
MS is a chronic, debilitating disease of the central nervous system. Severity of the disease may vary from person to person, and include symptoms such as numbness, tingling, vision problems or difficulty walking.
“MS affects our emotional and physical health in different and often unexpected ways. For many of us, the first reaction is denial, and we can take extraordinary measures to hide our symptoms. I didn’t talk about what was happening, even to my husband, because it was just too hard to explain,” said Ms. Salerno Kent, who is also a paid spokesperson for Acorda Therapeutics. “My journey from denial to hope was possible because of my passion for music, it inspired me and gave me the courage to retake control of my life. I hope that now my story and my music can help others to pursue their passions and use that strength to face MS head on and get the care they need and deserve. I like to say that the word ‘dreams’ may end in ‘ms,’ but MS doesn’t have to end our dreams.”
In “Dreams,” Ms. Salerno Kent explains how she wanted to become a performer because of the opportunity it offered to connect with people in the audience and other performers, but strange symptoms, including difficulty walking, made her too afraid to perform. She eventually gave up her dreams ofBroadway and moved to Atlanta, where she married her high school sweetheart, Michael. While planning her wedding she received the devastating news: she had MS.
Years later Ms. Salerno Kent was presented with an unexpected opportunity to perform. She decided to take a chance, and the experience showed her that she could still perform even though she was living with MS. She went on to write and produce her first album, “Believe,” and to direct an award winning documentary about MS called “The Show Must Go On, ” and now performs for audiences across the U.S. She is also the proud mom of a son and a daughter.
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