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(Medical Xpress)—Like conducting an errant orchestra to play together, researchers are guiding processes that go awry in multiple sclerosis to repair themselves.
The conductor walks to the stand and takes his place in front of the orchestra. He raises his baton and, with a dramatic flourish, one hundred individuals come to life. From nowhere, the stillness becomes a beautiful harmony as each member takes their part in a complex symphony.
Consider the workings and structure of the human brain – our most complicated organ – in terms of this orchestra. When it works, it is capable of something more remarkable than the greatest musical compositions in human history, but when it is affected by a condition such as multiple sclerosis (MS), "the brain's tightly orchestrated biological functions become discordant – the conductor begins to fail at their job and several instruments go out of tune," said Professor Robin Franklin, Head of Translational Science at the Wellcome Trust-Medical Research Council (MRC) Cambridge Stem Cell Institute and Director of the MS Society Cambridge Centre for Myelin Repair.
His research team and those led by other Stem Cell Institute researchers Drs Thóra Káradóttir, Mark Kotter and Stefano Pluchino are each looking at a different aspect of this errant orchestra. They hope that their collective knowledge will one day help 're-tune' the brains of MS patients to self-repair.
In its simplest terms, MS is a disease in which the immune system turns on itself, destroying the oligodendrocytes that make a protective sheath called myelin, which encases nerve fibres. This halts the transmission of neural messages, and eventually leads to nerve fibre damage, resulting in a progressive loss of movement, speech and vision for the 100,000 people in the UK who have MS.
However, the complexities of treating the disease go beyond simply stopping the destruction of myelin, said Franklin: "The myelin damage causes a build-up of debris, which needs removing, and the environment surrounding the cells needs to be conducive to regenerating the sheath. When we think about repairing the damage, we need to be considering several different biological phenomena at the same time."
BOSTON — Smoking appears to increase the likelihood of developing neutralizing antibodies to natalizumab (Tysabri, Biogen Idec), which cause the drug to have little, if any, therapeutic effect in multiple sclerosis (MS), a new study suggests.
The study was presented by Tomas Olsson, MD, Karolinska Hospital, Stockholm, Sweden, at the recent MS Boston 2014, the 2014 Joint Americas and European Committees for Treatment and Research in Multiple Sclerosis (ACTRIMS/ECTRIMS) meeting.
"The lung seems to be an important immunoreactive organ where irritation such as smoking may increase risk not only for inflammatory diseases, but also neutralizing antibodies to biologicals like interferon β and monoclonal antibodies such as natalizumab," he concluded.
"While smoking should not prohibit use of natalizumab, the percentage of patients developing antibodies, neutralizing the effect of the treatment, is not negligible," Dr Olsson commented to Medscape Medical News. "Therefore patients should be advised about our findings. This comes on top of an increased risk for MS with smoking, and probably a worse disease course."
Cambridge biotech Biogen Idec Inc. said Friday it will charge $62,036 per patient for a year’s treatment with its newly approved multiple sclerosis drug Plegridy.
The list price of Plegridy, a new type of injectable drug that treats adults with the most common form of MS, is identical to that of Biogen Idec’s original injectable, Avonex, which is still on the market.
Plegridy, a longer-lasting drug for patients with relapsing-remitting MS, was approved by the Food and Drug Administration on Aug. 15 for US sale. Biogen Idec disclosed the price Friday before releasing the drug to distributors.
“We’re pricing for the innovation,” said Biogen Idec spokeswoman Kate Niazi-Sai. “But we’re also pricing to make sure patients have access to it and the system can support it. That’s a balance, and that’s what we’re trying to do here.”
Drug pricing has become a hot button issue in an era of rising health costs.
Payments for Sovaldi, a $1,000-a-day pill to treat hepatitis C, has strained the finances of health insurers. Sovaldi, sold by California-based Gilead Sciences, costs $84,000 for a three-month treatment regimen. Last month, another Cambridge biotech, Genzyme, priced its new pill to treat Gaucher disease at $310,250 a year for the small population of US patients suffering from the rare genetic disorder.
Healthy eating lowers your risk of diabetes, hypertension, and heart disease, but it's not yet clear if that's true for Alzheimer’s disease as well.
“I can’t write a prescription for broccoli and say this will help—yet,” says Sam Gandy MD, PhD, the associate director of the Mount Sinai Medical Center Alzheimer’s Disease Research Center, in New York City.
(The National Institutes of Health has said there is insufficient evidence that food, diet, or lifestyle will prevent Alzheimer’s disease.)
It’s not a lost cause though. Here are 9 foods that researchers think will keep your whole body—including your brain—healthy.
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Editor's Note: While onsite at the Joint 2014 Americas Committee for Treatment and Research in Multiple Sclerosis/European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS/ECTRIMS) conference in Boston, Massachusetts, Medscape spoke with Sushrut Jangi, MD, of Brigham and Women's Hospital, about the possible link between our gastrointestinal microbiome and multiple sclerosis (MS).
Medscape: Your study looked at the potential relationship between gastrointestinal flora and MS. What were the objectives of your study?
Dr Jangi: In many autoimmune diseases there has been a lot of recent interest in trying to determine how what we eat, how the kind of bacteria that live in our gut, might influence the immune system. Eighty percent of the immune system is in the gut and is probably shaped by what grows in the gut. For example, in rheumatoid arthritis and inflammatory bowel disease, we've seen that the gut microbiome probably makes a difference and alters the expression of those diseases.
We've also seen that when the gut flora in mice are changed, it affects whether they acquire the MS-like disease experimental autoimmune encephalomyelitis (EAE). EAE is similar to MS in that when you give certain immunogenic compounds to mice, they develop a disease that looks very similar to MS. They get demyelination and disrupted nerve conduction, leading to deficits similar to those seen in MS. This model has allowed us to investigate how the pathogenesis of MS works.
So, given the work in mice with EAE and the fact that there was no study looking at this relationship in humans, we wanted to determine what the constituents of the gut microbiome are in MS patients compared with non-MS patients. We studied 105 patients and recently expanded our cohort to 250.
Medscape: And was there a difference?
Dr Jangi: The preliminary data show that there are at least a couple of different genera of bacteria that are different in the gut of MS patients compared with healthy controls. We found that a bug calledMethanobrevibacteriaceae is enriched in the gut of MS patients and seems to have immunoproliferative properties that drive inflammation. We also found that the population of Butyricimonas bacteria is low in MS patients compared with healthy controls. This is an interesting result because these bacteria produce butyrate, which is thought to be immunosuppressive, but we do need to repeat this study in a larger cohort.
So it seems that our work initially supports the idea that the gut in MS patients contains bugs that drive inflammation and are low in the types of bacteria that control inflammation. This is consistent with work in rheumatoid arthritis and inflammatory bowel disease.
Medscape: Would you go so far as to say that gut flora might actually cause MS?
By Gale Scott | September 29, 2014
Patients with the relapsing-remitting (RRMS) form of multiple sclerosis (MS) have shown improvement with glatiramer acetate (Copaxone/Teva). But researchers are still uncertain exactly how the drug works.
In research published online Sept. 29 in Jama Neurology a University of Texas Southwestern Medical Center team in Dallas, TX, reported on the ways in which glatiramer acetate affects B cells in these patients.
Nancy Monson, PhD, and colleagues looked at cell samples from 22 patients with MS who were receiving treatment with glatiramer acetate, 22 RRMS patients who were treatment naïve, and 15 healthy controls. They found that glatiramer acetate therapy affects several aspects of dysregulated B-cell function in MS. These changes “may contribute to the therapeutic mechanisms of glatiramer acetate,” the team wrote. The B cells of patients with RRMS lose the ability to produce the regulatory cytokine interleukin 10. The question for the team was whether glatiramer acetate would normalize cytokine production.
They found that the therapy affects B-cell function but that “the exact contribution of B-cell-derived cytokines in MS is not clear.” The researchers said they suspect that the drug affects the pathway of B-cell activation.
“It stands to reason that glatiramer acetate therapy may alter pathways that are important for integrating these activation signals and other key immunologic genes that are modulated by glatiramer acetate therapy,” they wrote.
The International MS Genetics consortium recently identified more than 45 new genetic variants associated with susceptibility to multiple sclerosis, many of which are involved in brain function
The list of genetic variants associated with multiple sclerosis grew even longer earlier this year at the joint ACTRIMS-ECTRIMS conference in Boston. According to a presentation by Philip De Jager, M.D., of Brigham and Women’s Hospital, Harvard Medical School, and the International MS Genetics Consortium, there are now more than 159 such genetic variants. Previous genome-wide association studies (GWAS) published in 2013 identified a total of around 110 variants.
The study that De Jager presented consisted of three parts: First, the team performed a meta-analysis of existing MS GWAS. Taken together, the data spanned over 14,000 individuals with MS. In an interview with MSDF, De Jager mentioned that no one had ever undertaken a meta-analysis of this scale in the field of multiple sclerosis genetics before.
From the meta-analysis, the team isolated new genetic variants and then performed a replication study in over 20,000 individuals with MS. This interim analysis confirmed 48 new variants, although De Jager said that the group will likely report more variants in the final version of the study that they plan to publish later this fall.
Researchers are working to refine a cell-based assay that more accurately identifies antibodies for myelin oligodendrocyte glycoprotein (MOG) in the serum of patients with neuromyelitis optica spectrum disorders. Some think that anti-MOG-positive patients may even represent a distinct demyelinating disease.
Scientists understand neuromyelitis optica spectrum disorders (NMOSD) far better now than when they were first described as Devic’s disease in 1894. NMOSD is an umbrella category including optic neuritis, myelitis, and acute disseminated encephalomyelitis (ADEM). While researchers understand NMOSD far better than they did even 10 years ago, so much remains obscured.
As we described in our four-part News Synthesis on NMO, researchers and clinicians believed NMO to be a subtype of multiple sclerosis until 2005, when researchers discovered a biomarker for the disease in an antibody that attacks a protein in astrocytes known as aquaporin-4. AQP4 is an integral membrane protein that helps conduct water through the cell membrane. According to Brian Weinshenker, M.D., of the Mayo Clinic in Minnesota, roughly 70% to 80% of adult NMOSD patients test positive for AQP4. Most of them are women.
Unfortunately, anti-AQP4-positive patients usually receive a dire prognosis. Relapses and disabilities are common, while recovery from the attacks tends to be incomplete. The body seems to attack the optic nerves and spinal cord, leading to problems in vision and walking.
To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.
To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
To evaluate the pharmacokinetics (PK) of teriflunomide.
Analyzing a large medical
database, researchers have found that patients with MS have an increased risk
of bipolar disorder.
Researchers in the UK, led
by Dr. Sreeram Ramagopalan of the University of Oxford and Evidera in
London, analyzed the Hospital Episode Statistics database of hospital
admissions in England.
With the statistical
records of hospital admissions and the death certificates for the whole of
England from 1999 to 2011, researchers tested whether MS patients are at an
increased risk of schizophrenia and bipolar disorder. They found that patients
with MS were at a significantly higher risk for schizophrenia; schizophrenia,
schizotypal, and delusional disorders; and bipolar disorder. These associations
were seen in males and females.
Caregivers are advised to
appropriately diagnose and manage these conditions in patients with MS.
Further, the results suggest shared causes between these disorders.
The research was presented at the
ACTRIMS-ECTRIMS MS Boston 2014.
Researchers found that
stem cell transplantation may be safe and feasible for MS patients. Using stem
cells harvested from the bone marrow of the test subjects, the Phase I study
suggests that the procedure deserves further study.
Following up on prior
studies that found that stem cells were safe and effective in the treatment of
other diseases, 24 participants with relapsing forms of MS were involved in a
study that tested the use of bone-marrow-derived, culture-expanded Mesenchymal
stem cells (MSCs). Led by Dr. Jeffrey Cohen of the Cleveland Clinic,
researchers injected 16 women and eight men – 10 with relapsing-remitting and
14 with secondary-progressive MS – with MSCs and found that cell infusion was
well-tolerated, and there were no treatment-related severe or serious adverse
While neither disease
activation nor significant improvement was observed, researchers said that
future trials to assess efficacy more definitively are warranted.
Cohen’s research was
presented at the ACTRIMS-ECTRIMS MS Boston 2014.
Multiple sclerosis patients show improvement when damaged cells are replaced with placenta.Photo courtesy of Shutterstock
Sept 29, 2014
Multiple sclerosis is a chronic, life-altering incurable disease, but an unprecedented treatment may have opened doors up for a successful treatment using cells from human placenta tissues. Researchers from Mount Sinai designed the treatment and have found patients were able to handle the treatment, and published their results in the journalMultiple Sclerosis and Related Disorders.
"This is the first time placenta-derived cells have been tested as a possible therapy for multiple sclerosis," the study’s lead author Fred Lublin, Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, said in a press release. "The next step will be to study larger numbers of MS patients to assess efficacy of the cells, but we could be looking at a new frontier in treatment for the disease."
When a patient is diagnosed with MS, an autoimmune disease that causes the body’s immune system to attack itself and disrupt the flow of information between the brain and the rest of the body, according to the National Multiple Sclerosis Society. More than 2.3 million please are affected by MS and while symptoms are unpredictable and can vary greatly in severity from one person to another, it always worsens overtime. The damaged nerve cells were repaired and tolerated by the MS person’s body successfully with PDA-001, a group of cultured placenta cells that resemble the connective tissue found in bone marrow. A placenta is a organ that encases the fetus inside a pregnant woman's womb, rich in oxygen and nutritents. By using cells cultured from placentas, researchers were able to extract significantly more of these cell-repairing cells from one donor, so they could supply many patients at a time.
Researchers examined the treatment in 16 patients with MS, some had relapsing-remitting multiple sclerosis (RRMS) and others had the more evolved version of the chronic and more debilitating condition called secondary progressive multiple sclerosis (SPMS). Patients were between the ages of 18 and 65 and one group was given a high dose of PDA-001, another were given a low dosage, and a third group was given a placebo. While there is always a risk for MS to worsen once the immune system is experimented with in cell transplants, over the six-month treatment the majority of the patients who were treated with PDA-001 had stabilized or showed improvement.
"We're hoping to learn more about how placental stromal cells contribute to myelin repair," Lublin said. "We suspect they either convert to a myelin making cell, or they enhance the environment of the area where the damage is to allow for natural repair. Our long-term goal is to develop strategies to facilitate repair of the damaged nervous system."
The Food and Drug Administration granted Orphan Drug Designation to Inhibikase Therapeutics’, Inc. lead product, IkT-001Pro (imatinib), to treat progressive multifocal leukoencephalopathy (PML).
According to the National Institute of Neurological Disorders and Stroke, PML affects the white matter of the brain usually through a virus known as Polyomavirus JC (JC virus). If left untreated, JC virus can destroy motor neurons and cognitive ability, eventually leading to death.Multiple sclerosis patients are particularly prone to PML due to their lowered immunity from their disease and use of certain drugs.
“Multiple sclerosis can be a very disabling disease. To date, Tysabri® is our most effective treatment,” explained Dr. Jeffrey B. English, Director of Clinical Research at the MS Center of Atlanta, in a news release. “Unfortunately, it carries a risk of a life threatening brain infection that can lead to PML. There are ways to screen for PML early, but we have no effective treatments for this disease.”
To address this need, Inhibikase has been researching and developing imatinib for delivery to patients with PML. Imatinib is a host-directed protein kinase inhibitor that interferes with JC virus replication. It has also been implicated in Novartis AG’s anti-cancer drug Gleevec® to treat blood and stomach cancers. To safely deliver imatinib to PML patients by reducing the required dose and side effects, Inhibikase formulated imatinib using its proprietary technology to make IkT-001Pro. “The anti-JC virus activity of imatinib cannot be achieved by simply altering the frequency or amount of Gleevec given to patients,” said Milton H. Werner, PhD, President and CEO of Inhibikase. “Early trial work has already shown this. To succeed, we’re talking reengineering how imatinib is absorbed and distributed in the body.”
Since Inhibikase is essentially developing a new drug, it must go through clinical trials, which can be a burden for diseases with small populations. “The Designation will enable resources for continued development, but more importantly the Designation provides an additional avenue for discussion with the FDA on the best path for bringing IkT-001Pro to market. PML is a rare side effect of at least 13 beneficial medications, and PML may also arise as a side effect of many more medications now in clinical development.”
The trial, initiated in 2007 by a group led by Bruce Cree, MD, PhD, at the University of California, San Francisco, sought to evaluate changes in quality of life for multiple sclerosis patients following treatment with 4.5 mg naltrexone (LDN). Eighty patients were enrolled in the trial, and treatment was administered nightly for eight weeks. Of primary interest was a difference in mean score of the multiple sclerosis quality of life inventory (MSQLI54) between LDN-treated and placebo-treated patients.
According to results published in 2010 in the journal Annals of Neurology, at the end of the trial, sixty patients had completed treatment. Ten patients withdrew before the end of the first trial period, but none withdrew due to a multiple sclerosis-LDN adverse event. In fact, one patient withdrew early due to a perceived benefit of treatment. Results from the other ten patients were not available due to database management errors and incomplete quality of life surveys.
In today’s healthcare environment, it is often not enough that patients are provided with the latest treatments. Good health is not merely the absence of injury or disease, but overall wellness that includes mental, spiritual and social health. A group of investigators from the Kessler Foundationrecently published their findings from a psychoeducational wellness program for patients with multiple sclerosis (MS) — an autoimmune neurological disorder that affects between 300,000 and 400,000 Americans and about 2.5 million individuals worldwide.
Out of 54 MS patients, 43 participated in the wellness program. Every week for ten weeks, they participated in 90-minute sessions meant to positively influence their intellectual, spiritual, and emotional well-being. The remaining 11 comprised the study’s control group, but all participants were assessed for depression, perceived stress, anxiety, mental health, pain, presence and quality of social support and reports of fatigue.