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Tuesday, December 30, 2014

MS Views and News seeks a Grant Writer/Admin Ass't

MS Views and News seeks a Grant Writer/Admin Ass't

Not for profit seeks a grant writer-general assistant, for growing Multiple Sclerosis patient advocacy organization.

MS Views and News provides education and information for the global Multiple Sclerosis community via the internet and live seminars.

Skills Needed: Strong writing ability, organization and the ability to work independently and with a team.

Please Contact:    



Monday, December 29, 2014

Cognitive Study in MS Highlighted Among Most Important of 2014

December 23, 2014
The Editorial Board of Neurology Today, a journal of the American Academy of Neurology, selected a study about cognition and MS among the most important studies published in 2014, suggesting the need for earlier rehabilitation for people with MS who experience cognitive problems. Read more from Neurology Today.
Read more about MS research progress made in 2014.

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Immunosuppressive Therapy and Stem Cell Study for Multiple Sclerosis

2014-12-29 17:45
immunosuppressive therapy multiple sclerosis
Investigators have just released the interim results of a five-year study of high-dose immunosuppressive therapy (HDIT) and hematopoietic stem cell therapy in 24 individuals with multiple sclerosis. After three years, most of the participants showed improvements in neurological function and sustained remission of active relapsing-remitting MS (RRMS).
The new JAMA Neurology article reports the findings of the Hematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS) study. Basically, the idea is that use of HDIT supported by autologous (use of a patient’s own cells) hematopoietic stem cell infusions (transplantation) will stop disease activity in individuals who have poor prognosis RRMS.
In this study, autologous hematopoietic cell transplantation involved removing CD34 stem cells and storing them while the individuals were treated with high-dose immunosuppressive therapy; that is, the chemotherapy drugs carmustine, cytarabine, etoposide, and melphalan. The stored hematopoietic stem cells, which are responsible for the formation of blood, were then transfused into the patient’s bloodstream
At the three-year evaluation point, the authors found that, without the use of any maintenance therapy:
  • Overall rate of event-free survival (i.e., survival without loss of neurologic function, new lesions seen on imaging, or clinical relapse) was 78.4 percent
  • Progression-free survival was 90.9 percent
  • Clinical relapse-free survival was 86.3 percent
  • Quality of life, functional scores, and neurological disability all also improved
The authors concluded that the combination of high-dose immunosuppressive therapy and hematopoietic stem cell transplantation “may represent a potential therapeutic option for patients with MS in whom conventional immunotherapy fails.” However, they also emphasized that “longer follow-up is needed to determine the durability of the response.”
This combination therapeutic approach is not without side effects. The most common adverse events were cytopenias (64%), infections (56%), gastrointestinal disorders (36%), metabolism disorders (32%), and nervous system issues (24%), such as headache.

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a CME program for : Assessing Patient Adherence in MS:

MS leaders e-mail logo header

Program provided by MS-Leaders

Dear MS-Leaders Registrant,

Can you correctly answer this question:

All of the following are INDIRECT measurements that can be used to evaluate adherence to disease-modifying therapy, EXCEPT for:

A. Detection of the drug in blood or urine
B. Patient self-reports
C. Prescription claims data
D. Electronic medication monitors

Participate in our Clinical Dialogue and eCase Challenge to learn the answer to this and other questions related to MS therapy.


Rutgers, The State University of New Jersey and Medical Logix, LLC, are currently offering this educational program certified for CME and CE credit, at no charge to participants:

Release Date: July 14, 2014
Expiration Date: July 14, 2015

This enduring material has been approved for
AMA PRA Category 1 Credits™ and ANCC contact hours.

Supported by educational grants from
Genzyme, a Sanofi Company and Teva Pharmaceuticals

Jointly Provided by The Center for Continuing and Outreach Education
at Rutgers Biomedical and Health Sciences and Medical Logix, LLC

For additional information and to view the activity, please CLICK HERE 

Please keep in mind that you will need to login with your email address and password to access this program. If you forgot your password, click on the "Forgot Password" link in the top right corner of the site.

We hope you enjoy this informative educational program!

The MS-Leaders Team

The Center for Continuing and Outreach Education at
Rutgers Biomedical and Health Sciences
 30 Bergen Street ADMC7, Newark, NJ 07101-1709

Please do not respond to this email directly. Any questions or concerns,

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Saturday, December 27, 2014

British Columbia Agrees To fund AUBAGIO RRMS Therapy

December 26, 2014

GenzymeBritish Columbia’s PharmaCare drug program has announced that it will fund AUBAGIO, a therapy developed by Genzyme for the treatment of multiple sclerosis. AUBAGIO (teriflunomide) 14 mg has been officially added to PharmaCare’s provincial formulary as a first-line oral agent for patients suffering from relapsing remitting multiple sclerosis (RRMS).
As an immunomodulator with anti-inflammatory properties, AUBAGIO is specially indicated for RRMS and has been proven effective in the reduction and frequency of clinical exacerbations due to MS, as well as in delaying the progression of physical disability. The monotherapy was approved in Canada in November of last year, and even though its mechanism has not been completely understood, Aubagio is able to decrease the amount of activated lymphocytes in the central nervous system (CNS).
“We are pleased to have an additional therapy available to us in the treatment of MS. Having access to this new oral therapy will allow us to tailor our treatment to our patients’ needs. We are grateful to the provincial drug program in BC for approving access to this therapy in 1st line,” said Virginia Devonshire, who is a Clinical Assistant Professor Neurology at the UBC.
Genzyme’s development of AUBAGIO included a clinical program that involved more than 5,000 trial participants in 36 different countries. Moreover, the company has also studied the progression of patients who were treated in extension trials for up to 10 years, and the researchers demonstrated that the therapeutic’s benefits have extended throughout the duration of the treatment

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MS Clinical Focus: The Wahls Protocol

Terry Wahls, MD, talks about her popular regimen for progressive MS.

For Video- click here:

With no clearly proven treatments available for progressive forms of multiple sclerosis (MS), the door has been opened for what are usually called alternative or complementary therapies. One that has gained many adherents in the MS community is the Wahls Protocol, a regimen of diet, exercise (including electrical neuromuscular stimulation), and meditation techniques.

MedPage Today asked for comments from its eponymous developer, Terry Wahls, MD, clinical professor of medicine at the University of Iowa Carver College of Medicine in Iowa City. Wahls is an MS patient and devised the protocol initially for herself. On her website, she claims to have climbed out of a wheelchair and improved enough to complete an 18-mile bike ride within 1 year.

In the accompanying video, Wahls describes the regimen and the ongoing clinical studies with which she is involved.

MedPage Today also contacted neurologists at academic medical centers to ask for brief comments on the Wahls Protocol. Not surprisingly, their assessments were more cautious:

"I am a firm believer in the power of good nutrition, exercise, intense rehabilitation, and a great attitude, but they have to go hand in hand with the medical treatment -- as clearly stated by Dr. Wahls, she underwent chemotherapy, which likely played a role in slowing the progression of her disease." --Flavia Nelson, MD, University of Texas Health Science Center in Houston

"Wellness promotion approaches including a healthful diet, exercise, and stress reduction are widely recommended by MS experts to their patients. That said, neither Dr. Wahls' program, nor any other wellness regimen, regardless of how thoughtfully conceived and well intentioned, has been proven rigorously to alter the MS disease process in randomized, controlled trials such as those required by the FDA for the approval of new therapies. Naturally, we all want people with MS to feel better and do better, but we ought to be cautious about possibly promoting false hope." -- Andrew Goodman, MD, University of Rochester in New York.

Continue reading

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Thursday, December 25, 2014

Link between contrast agent and brain abnormalities on MRI

Dec 23, 2014
We would like to thank Jackie from California for this article

For the first time, researchers have confirmed an association between a common magnetic resonance imaging (MRI) contrast agent and abnormalities on brain MRI, according to a new study published online in the journal Radiology.The new study raises the possibility that a toxic component of the contrast agent may remain in the body long after administration.
Brain MRI exams are often performed with a gadolinium-based contrast medium (Gd-CM). Gadolinium's paramagnetic properties make it useful for MRI, but the toxicity of the gadolinium ion means it must be chemically bonded with non-metal ions so that it can be carried through the kidneys and out of the body before the ion is released in tissue. Gd-CM is considered safe in patients with normal kidney function.
However, in recent years, clinicians in Japan noticed that patients with a history of multiple administrations of Gd-CM showed areas of high intensity, or hyperintensity, on MRI in two brain regions: the dentate nucleus (DN) and globus pallidus (GP). The precise clinical ramifications of hyperintensity are not known, but hyperintensity in the DN has been associated with multiple sclerosis, while hyperintensity of the GP is linked with hepatic dysfunction and several diseases.
To learn more, the researchers compared unenhanced T1-weighted MR images (T1WI) of 19 patients who had undergone six or more contrast-enhanced brain scans with 16 patients who had received six or fewer unenhanced scans. The hyperintensity of both the DN and the GP correlated with the number of Gd-CM administrations.
"Hyperintensity in the DN and GP on unenhanced MRI may be a consequence of the number of previous Gd-CM administrations," said lead author Tomonori Kanda, M.D., Ph.D., from Teikyo University School of Medicine in Tokyo and the Hyogo Cancer Center in Akashi, Japan. "Because gadolinium has a high signal intensity in the body, our data may suggest that the toxic gadolinium component remains in the body even in patients with normal renal function."
Dr. Kanda noted that because patients with multiple sclerosis tend to undergo numerous contrast-enhanced brain MRI scans, the hyperintensity of the DN seen in these patients may have more to do with the large cumulative gadolinium dose than the disease itself.
The mechanisms by which Gd-CM administration causes hyperintensity of the DN and GP remain unclear, Dr. Kanda said. Previous studies on animals and humans have shown that the ion can be retained in bone and tissue for several days or longer after administration.
"The hyperintensity of DN and GP on unenhanced T1WI may be due to gadolinium deposition in the brain independent of renal function, and the deposition may remain in the brain for a long time," Dr. Kanda suggested.

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Shining a light on MS rates in USA

The Pacific Northwest is a great place to live. However, we have one of the highest rates of multiple sclerosis.
A couple factors contribute to our region’s high rate of MS. One, our population is predominantly of northern European descent, the ethnic group at the highest risk of MS. And second, growing evidence suggests our low levels of vitamin D – the “sunshine vitamin” – may play a role in development of MS. (Prevalence of MS in sunny southern states is much lower than northern states.)

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New Study Shows A Link Between The Hep B Vaccine And Multiple Sclerosis, Again

Study shows the link between the Hepatitis B vaccine and Multiple Sclerosis, again.
The link between the Hepatitis B vaccine and an increase risk of multiple sclerosis has been something of concern for a number of years since a increase in vaccinations in France led to a dramatic rise in cases of multiple sclerosis, also called MS. Now a new study being reported by Overcoming Multiple Sclerosis shows the link between the vaccine and the rise in MS cases — and explains what the mechanism may be behind this link, as well as other possible vaccine injuries and further supports older studies that found the same link from back in 2004 by a Harvard team.
Read more 

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The Latest on the Anti-Lingo studies for Remyelination in MS

December 25, 2014

Recently people have been asking me to tell them what is happening with Anti-Lingo and so, below, you can read the most recent information that I could find on this subject.

BIIB033, a monoclonal antibody targeting the LINGO-1 remyelination signaling block, passes phase 1 safety tests

A high-profile experimental treatment to repair the damaged myelin around nerves in people with multiple sclerosis (MS) has passed its first clinical testing milestone. The drug, a monoclonal antibody called BIIB033 (Biogen Idec), is safe and tolerable in people, according to the combined results of two phase 1 clinical trials that tested high doses in healthy people and in people with MS.

“We have now reached a potential turning point in MS therapeutics,” according to an editorial published online August 27 with the phase 1 study results in the journalNeurology, Neuroimmunology & Neuroinflammation (Brugarolas et al., 2014Tran et al., 2014).

“The anti-LINGO-1 trial is likely the first of many that will test drugs that have been shown to enhance remyelination in [mouse] models,” wrote Pedro Brugarolas, Ph.D., and Brian Popko, Ph.D., of the University of Chicago, Illinois, in the editorial. “Soon we should know whether this approach will provide benefit to patients with MS, which would be the first evidence that enhancing myelin repair may alter the course of this disease.”

The antibody Li81 (BIIB033, Biogen) in hot pink binds to the signaling molecule LINGO-1 (yellow) in an unexpected four-way structure  to induce myelination, shown here in two potential configurations.  Image courtesy of Sha Mi and the <em>Journal of Pharmacology and Experimental Therapeutics</em> (Pepinsky <em>et al</em>., 2014).
The antibody Li81 (BIIB033, Biogen) in hot pink binds to the signaling molecule LINGO-1 (yellow) in an unexpected four-way structure to induce myelination, shown here in two potential configurations. Image courtesy of Sha Mi and the Journal of Pharmacology and Experimental Therapeutics (Pepinsky et al., 2014).

With no proven treatments for the progressive forms of MS that cause severe disability, attention has become riveted on ways to repair and restore the myelin that surrounds and protects axons from neurodegeneration (Franklin et al., 2014).

An estimated 2 million people have MS worldwide, including about 450,000 in the United States. Most people are diagnosed with relapsing-remitting MS, marked by disabling episodes of immune activity, often followed by increasing disability. The 11 U.S.-approved treatments for MS reduce immune damage to the myelin and axons in seven different ways, but there is little evidence they reduce disease progress and long-term disability.

The phase 1 clinical studies of BIIB033 tested an experimental drug that restores myelin in mice. Generally, for remyelination to occur, oligodendrocyte precursor cells (OPCs) must survive, multiply, migrate to the lesion, and transform into mature oligodendrocytes that encircle axons with compact myelin sheaths. In MS, OPCs seem to be abundant in lesions but unable to differentiate. Animal and cell studies show that BIIB033 works at this final stage. It shuts down a signaling molecule, LINGO-1, that normally blocks OPCs from differentiating into myelin-making cells (Mi et al., 2004Pepinski et al., 2014).

In one study that ended in October 2011, 72 healthy people were randomized, with three-quarters receiving a single injection of the drug and the others a placebo. In the other study that finished in April 2012, 47 people with relapsing-remitting MS or secondary progressive MS were randomized, with twice as many receiving the drug as placebo, most of whom receive two injections about two weeks apart. In both groups, participants received escalating doses up to 100 mg/kg.

The researchers had expected a large dose would be necessary for a sufficient amount of the drug to reach the CNS, author Diego Cadavid, M.D., told MSDF in an interview. “It’s a large molecule,” said Cadavid, the medical director for the anti-LINGO-1 development program at Biogen Idec in Cambridge, Massachusetts. “The blood-brain barrier limits the movement of large molecules.”

“Surprisingly, in this study, the concentration of BIIB033 in the [cerebrospinal fluid] did not appear to correlate with the dose administered,” Brugarolas and Popko wrote in the editorial.

phase 2 study currently underway may help clarify the necessary dose. 
Named SYNERGY and launched 1 year ago, it tests four BIIB033 doses ranging from 3 mg/kg to 100 mg/kg, given as an infusion every 4 weeks. The phase 2 study includes once-weekly injections of interferon β-1a (Avonex, Biogen) for people in both the experimental and placebo arms.

In another finding from the phase 1 studies, the authors found a low rate of antibody production, which indicates an immune response that makes the drug ineffective. But they also found antibodies in a placebo-treated person. “A better assay may be needed,” the editorial writers observed.

Other side effects were mild to moderate, unrelated to the drug, and similar in people who received the placebo. Side effects included headaches, upper respiratory infections, and urinary tract infections. No serious side effects or deaths were reported. The drug did not detectably worsen the disease in people with MS.

The next big question for BIIB033 is: Does it work in people? The SYNERGY trial and those for other potential remyelination drugs face an unusual hurdle. “A big problem in the field, a Catch-22, is that we don’t have a good trial design for detecting remyelination,” said neuroradiologist and neurologist Daniel Reich, M.D., Ph.D., chief of the translational neuroradiology unit at the U.S. National Institute of Neurological Disorders and Stroke, in an interview with MSDF. “And we don’t have [a known] remyelinating drug with which to test remyelinating study design. Every trial will be testing both the drug and the trial design. You’ve got to hit them both to get a positive result. That’s tough.”

The phase 1 studies also tested candidate MRI techniques to measure remyelination that have also been deployed to capture secondary outcomes in the phase 2 trial, Cadavid pointed out to MSDF. One helpful data set that emerged was the results of two to three MRIs taken on healthy individuals over 1 month as a reference, he said.

Reich is skeptical about the ability of the nonconventional MRI techniques, magnetization transfer and diffusion tensor imaging, to measure remyelination directly. On the other hand, he thinks that conventional MRI measures will be helpful in clinical trials to show normalized signals consistent with remyelination.

Cadavid’s group will present a poster at the upcoming joint ACTRIMS-ECTRIMSmeeting in Boston that will show other potential CSF biomarkers of remyelination. “It’s important to mention that the target, LINGO-1, is only expressed in the CNS,” he told MSDF. Peripheral biomarkers, such as blood and urine, are irrelevant, he said.

LINGO-1 is abundantly produced by neurons, as well as expressed by oligodendrocytes, and the signaling molecule increases in inflammatory lesions, Cadavid said. “We are testing whether blocking LINGO-1 leads to remyelination in MS.”

Article SOURCE found here

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'Futuristic' treatments come to fruition with cell and gene therapies

One-time treatments that could functionally cure rare diseases. Cyborg T cells trained to kill cancer. A biological hacking method that could allow scientists to rewire errant genes from within. This year, a host of moonshot technologies matured, stoking hopes for real-world applications.

The world of gene therapy--in which single-dose treatments correct debilitating defects--enjoyed something of a renaissance in 2014. Strong clinical results from leaders in the once-maligned field spurred renewed optimism, helping a new generation of startups secure millions in venture financing to develop their next-generation approaches to the field.

And that led to something of a trickle-up phenomenon in the industry, as the innovations of biotechs and academics convinced the world's biggest players to give the field a second look. Now Bayer, Pfizer (PFE), Biogen Idec (BIIB) and Astellas are among the many companies toiling in gene therapy, joining high-profile biotechs like bluebird bio (BLUE) and uniQure (QURE).

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Biogen Straps Fitbits Onto MS Patients' Wrists

The company, which has five MS drugs on the market, gave out 250 Fitbit bands to MS patients in the U.S. last spring to track their level of activity and sleep patterns. Mobility is affected by the disease, and Biogen says collecting data on a daily basis—about how much and how fast MS patients walk, for example—could yield data about the progression of the disease and lead to better treatments.
“Let’s say you see a patient four times a year—that’s two hours per year,” says Al Sandrock, Biogen’s chief medical officer. “You’re losing 364.9 days of other data that could be collected.”
The data also could help Biogen prove the value of its pricey medications to health insurers and pharmacy benefit managers, who are responding to rising drug prices by reducing the number of medicines covered. “It’s a smart investment,” says Tim Coetzee, chief research officer of the National MS Society. Express Scripts dropped Bayer’s MS drug Betaseron, directing patients to three other options, including Biogen’s Avonex. MS drugs cost at least $50,000 a year at wholesale prices, Coetzee says. “Having the tools to demonstrate the value of a particular agent is valuable,” he says.

“Betaseron is comparably priced to other MS treatments,” says Rosemarie Yancosek, a Bayer spokeswoman.
Decisions about which drugs to cover depend on several factors, says Express Scripts spokesman Brian Henry, including the number of drugs on the market, how they work, and their price. None of Biogen’s five MS drugs—Avonex, Fampyra, Plegridy, Tysabri, and Tecfidera—has been taken off the pharmacy benefit managers’ lists. The medicines are projected to bring in almost $8 billion in revenue this year.
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