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Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

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CHAMPIONS TACKLING MS - AWARDS Dinner, Honoring Aaron Boster, MD and Jon e. Glaser, DDS - now open for registration. Visit www.events.msvn.org

Wednesday, November 11, 2015

Composer Jeff Beal confronts MS diagnosis in new work with LA Master Chorale


POSTED: 
Jeff Beal was reeling from being diagnosed with multiple sclerosis when he put on “Cloudburst,” a luminous choral piece by composer Eric Whitacre.
A feeling of calm washed over him.
“I’ve always loved vocal music,” says Beal, the Emmy Award-winning composer behind Netflix’s “House of Cards” and a host of other film and television scores, speaking from his home studio in Agoura Hills. “As a meditative and quiet-your-mind thing, it is extremely powerful and healing.”
Inspired by his experience, Beal mediates on suffering and catharsis in his first original a cappella work, “The Salvage Men,” which has its U.S. premiere Sunday at Walt Disney Concert Hall with the Los Angeles Master Chorale as part of the Made in L.A. Concert.
The composition — a joint commission from the Master Chorale and the Eric Whitacre Singers — is one of several works created in the city that Master Chorale Artistic Director Grant Gershon calls “a hotbed for composers who write beautifully and evocatively for the human voice.”
Beal says he experienced numbness down the left side of his body for years, but it wasn’t until he was hobbling around South by Southwest Film Festival in spring 2007 that it struck him something might actually be wrong.



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Primary Progressive Multiple Sclerosis (PPMS) Therapeutic Pipeline Review, H2 2015

Primary Progressive Multiple Sclerosis (PPMS) - Pipeline Review, H2 2015
Summary
Global Markets Direct’s, ‘Primary Progressive Multiple Sclerosis (PPMS) - Pipeline Review, H2 2015’, provides an overview of the Primary Progressive Multiple Sclerosis (PPMS)’s therapeutic pipeline.
This report provides comprehensive information on the therapeutic development for Primary Progressive Multiple Sclerosis (PPMS), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Primary Progressive Multiple Sclerosis (PPMS) and special features on late-stage and discontinued projects.
Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.
The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.
Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
Click to continue reading


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Novartis' MS Drug Gilenya Prevents Activation of Key Immune Cells in Study


<span class="entry-title">Novartis’ MS Drug Gilenya Prevents Activation of Key Immune Cells in Study</span><span class="entry-subtitle">Study focus on immunosuppressive actions of the drug fingolimod</span>

In a recent study entitled “Myeloid cells as target of fingolimod action in multiple sclerosis,” a team of scientists investigated the impact of fingolimod (GilenyaNovartis), an approved drug for multiple sclerosis (MS), on the reactivity of myeloid cells, a key group that comprises several immune cells that are activated in MS patients and the underlying cause of the disease. The study was published in the journal Neurology.
MS is an autoimmune disease that affects the central nervous system and afflicts more than 2.3 million people in the world. Currently without a cure, the disease is characterized by the destruction of the myelin layer within nerve cells. This leads to a wide range of neurological symptoms affecting visual, motor, and sensory capabilities.
Fingolimod is one of the few treatments for MS and is an analogue of a cellular key protein called sphingosine. When added to cells, fingolimod binds sphingosine-1-phosphate (S1P) receptors and promote their degradation. Since S1P receptors are important for immune cells’ trafficking to the central nervous system, fingolimod reduces this trafficking and is thus associated with reducing MS-disease relapse and disability progression.
Researchers investigated how fingolimod influences the activation of myeloid cells from the periphery to the central nervous system. (Myeloid cells originate in the bone marrow or spinal cord and include several key cells in our immune system, such as monocytes, macrophages, neutrophils, basophils, eosinophils, erythrocytes, dendritic cells, and megakaryocytes or platelets.) The team analyzed how fingolimod interfered with the activation of immune cells in vitro and later performed further studies where administration of fingolimod during experimental autoimmune encephalomyelitis (a disease model of human MS) was used to assess its effects on the activation of splenic, central nervous system infiltrating, and central nervous system resident myeloid cells.
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Video: October 20th, 2015 - Empowering an MS Community In Americas' Heartland - with Dr. Aburashed


The above, was video recorded on October 20, 2015 from Novi (Detroit), Michigan

Open the video, scroll past the opening announcements, to reach Dr. Aburashed's candid MS talk



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Video: Social Security Disability Law (SSDI) - The disability insurance process




Lisa to Lisa Discuss Social Security Disability Law (SSDI)


Open the video, scroll past the opening announcements, to reach Lisa's Presentation about Social Security Disability



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A Resource for Caregivers


A CAREGIVER RESOURCE

                                        


If you or someone you know is facing the challenges of Caregiving, this is a resource that may help. A look at understanding the role of the Caregiver and the important points one needs to address prior to a discharge from the hospital or at a doctor's visit.

Explore this website: http://www.nextstepincare.org/

If you have needs or questions remember that you can always contact me:
jennifer@msvn.org  or 786-296-8777 



Sincerely, 
Jennifer Falk MSW,CPHM

MS Social Work Navigator- Projects Manager               



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Live Program Announcement for December 5th in Coral Gables (Miami) - ReThinking MS Together




To Learn More of this program, click the above flyer





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NON-MS related --National Do Not Call registry for Unwanted Calls


Receiving UNWANTED Calls?  If you are registered in the Do Not Call Registry, click the box showing below to provide your complaints fro unwanted calls





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Tuesday, November 10, 2015

Opexa Therapeutics Announces Supportive Preclinical Study Results for its Neuromyelitis Optica (NMO) Program

Nov. 10, 2015 21:05 UTC

Opexa Therapeutics Announces Supportive Preclinical Study Results for its Neuromyelitis Optica (NMO) Program

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized therapies for autoimmune disorders including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced results of a preclinical study, which show that T-cell immunotherapy with attenuated antigen-specific T-cells suppress the T-cell response to Aquaporin-4 (AQP4) in a dose-dependent manner, compared to vehicle control, as measured by reduction in both Aquaporin-4 reactive T-cell (ARTC) proliferation and associated cytokine activity. The results were statistically significant.

In NMO, activated T-cells (ARTC) mount an attack against Aquaporin-4, the autoantigen in NMO, leading to secondary demyelination of nerve fibers within the optic nerves and the spinal cord, resulting in the clinical symptoms of the disease. Opexa’s therapeutic approach is to suppress or reduce the number of these activated ARTC in patients with NMO. The results of the preclinical animal study provide evidence that T-cell immunotherapy reduces the level of activated ARTC in a murine (mouse) model.

“The results of the bioactivity study are encouraging as they support our proposed mechanism of action for OPX-212 in NMO,” stated Neil K. Warma, Opexa’s President and Chief Executive Officer. “NMO is a complex autoimmune disorder and we believe we are unique in developing a targeted and personalized T-cell immunotherapy for this disease which currently has no approved treatments. We believe that OPX-212, by addressing the T-cell component of the disease, may target the root cause of NMO. There is a significant unmet medical need for patients with NMO and this animal study is an important step in our development program for the treatment of patients with this debilitating disease. We are continuing with the preclinical development activities of OPX-212, including completing the manufacturing runs and expect to submit the IND to the U.S. FDA and be in a position to open a Phase 1/2 clinical study in NMO patients in the first half of 2016, assuming the availability of sufficient resources.”

“Opexa’s T-cell immunotherapy, OPX-212, has an hypothesized mechanism of action to reduce the number of and/or regulate Aquaporin-4 reactive T-cells, thereby reducing the frequency of clinical relapses and subsequent progression in disability,” stated Donald Healey, PhD, Opexa’s Chief Scientific Officer. “Aquaporin-4 reactive T-cells support pathogenic autoantibody production from B-cells in NMO, but also drive the T-cell mediated cytokine signaling and infiltration of inflammatory cells that also contribute to disease pathology. OPX-212 aims to restore immune tolerance in NMO patients by specifically targeting ARTC while leaving the rest of the patient’s immune system intact.”
As part of Opexa’s preclinical development activities for OPX-212, Opexa conducted a bioactivity study to demonstrate the ability of T-cell immunotherapy using attenuated T-cells to suppress a T-cell response to the NMO-associated autoantigen, AQP4. No animal model of NMO has been described that exhibits both endogenous T-cell dependent immunity and autoantibody production to AQP4 and that subsequently leads to the immunopathology and clinical symptoms observed in human NMO. To study the bio-activity of attenuated T-cells on AQP4 T-cell immunity, mice were pre-treated with attenuated antigen-specific T-cells and subsequently primed with AQP4 antigen, following which ARTC and associated inflammatory cytokine levels were measured.
NMO, also known as neuromyelitis optica spectrum disorder (NMOSD), is a rare autoimmune disorder, which is designated as an Orphan Disease by the U.S. Food and Drug Administration. There is currently no cure and there are no approved therapies for this disease, worldwide.

About OPX-212
OPX-212 is Opexa’s personalized T-cell immunotherapy in development for the treatment of NMO. It will be specifically tailored to each patient’s immune response to Aquaporin-4. In NMO, activated T-cells mount an attack against Aquaporin-4, the autoantigen in NMO, leading to secondary demyelination of nerve fibers within the optic nerves and the spinal cord, resulting in the clinical symptoms of the disease. Symptoms of the attack include blindness in one or both eyes followed within days or weeks by varying degrees of paralysis in the arms and legs. OPX-212 has an hypothesized mechanism of action to reduce the number and/or regulate aquaporin-4 reactive T-cells (ARTCs), thereby reducing the frequency of clinical relapses and subsequent progression in disability. OPX-212 will be manufactured using ImmPath®, Opexa Therapeutics’ proprietary T-cell immunotherapy platform technology.

About Opexa
Opexa is a biopharmaceutical company developing a personalized immunotherapy with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases such as neuromyelitis optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna consists of myelin-reactive T-cells, which are expanded ex vivo from the patient’s peripheral blood and reintroduced into the same patient in an attenuated form via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin for each individual patient.

For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO.

Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

Statements contained in this release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the safety, efficacy and projected development timeline of drug candidates such as Tcelna® and OPX-212 constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products such as Tcelna and OPX-212, our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date.


Contacts
Opexa Therapeutics, Inc.
Karthik Radhakrishnan, 281-775-0600
Chief Financial Officer


Source: Opexa Therapeutics, Inc.









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Affordable Healthcare Open Enrollment again open

Healthcare Marketplace Open Enrollment Begins!

It’s that time of year again when individuals can enroll in a Marketplace health insurance plan. According to the U.S. Department of Health and Human Services, the Affordable Care Act is working and continuing to increase access to healthcare. Insurance affordability has increased also, with the eligibility to qualify for lower premium costs, the expansion of Medicaid coverage and additional plan options to choose from being key factors in this act.


Healthcare.gov Homepage 2016

Important Dates to Remember:

  • November 1, 2015 - Open Enrollment Began:
    • Search for insurance plan options and assistance that may be right for you
    • If you are already enrolled, you can review your coverage and other insurance plans to see if another plan better matches your needs
  • December 15, 2015 - Last day to enroll for coverage beginning on January 1, 2016
  • January 1, 2016 - Coverage begins for everyone who enrolled by December 15, 2015




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Monday, November 9, 2015

New Multiple Sclerosis Study Reveals Protein’s Role in Disease Activation

<span class="entry-title">New Multiple Sclerosis Study Reveals Protein’s Role in Disease Activation</span><span class="entry-subtitle">Findings on interaction between Nr4a1 and T cells could make protein a new therapeutic target </span>

In a new study entitled “Transcription factor Nr4a1 couples sympathetic and inflammatory cues in CNS-recruited macrophages to limit neuroinflammation,” a team of scientists discovered the mechanism by which autoreactive T cells are capable of penetrating a patient’s brain and induce multiple sclerosis. The study was recently published in the advance online issue of Nature Immunology.
Multiple sclerosis is a neurological autoimmune disease characterized by the self-reactivity of T cells (key cells of the immune system) that trigger an attack, after cells have infiltrated the brain and spinal cord, against myelin (the substance that insulates nerve cells). With time, inflammation results in damage to myelin that impairs the normal functioning of the brain. A barrier called blood-brain barrier protects the brain from these autoimmune T cells. In multiple sclerosis, however, these cells can overcome the blood-brain barrier, although the mechanisms underlying this phenotype remain unknown.
A team of scientists at the La Jolla Institute for Allergy and Immunology (LJI) tackled this question and discovered that autoimmune T cells are conducted into the nervous system by other cells of the immune system, specifically monocytes and macrophages. As Catherine Hedrick, PhD, a professor in the Division of Inflammation Biology and one of the study’s lead authors, noted in a press release, “Our results show that macrophages and monocytes actively participate in the initiation and progression of multiple sclerosis, which has long been considered a primarily T cell driven disease. They exacerbate the severity of the disease by sending out chemical signals that boost inflammation and attract autoimmune T cells to the central nervous system.”
Iftach Shaked, PhD, a postdoctoral researcher in the laboratory of LJI professor Klaus Ley, PhD and study first author, added, “Multiple sclerosis affects millions of people worldwide. But what’s really puzzling is that we all have autoimmune T cells that recognize myelin basic protein but normally they do not infiltrate the central nervous system and cause disease.”
It is known that stress can play a role in the worsening of symptoms of inflammatory diseases, but the link between cellular stress and neuroinflammation remains poorly understood. Here, the team discovered that a protein known as Nr4a1 (an established factor responding to inflammatory and stress signals) prevented autoreactive T cells from infiltrating the central nervous system in mouse models of human multiple sclerosis. The team found Nr4a1 protein inhibited the production of norepinephrine. In the absence of Nr4a1, monocytes and macrophages continually produce norepinephrine, leading to the activation of macrophages and triggering a massive flow of T cells into the central nervous system.
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New Insights Into Immune Cells’ Behavior in MS May Lead To New Therapeutic Approach

Study finds modulating microRNA activity could impact the progression of diseases such as multiple sclerosis

<span class="entry-title">New Insights Into Immune Cells’ Behavior in MS May Lead To New Therapeutic Approach</span><span class="entry-subtitle">Study finds modulating microRNA activity could impact the progression of diseases such as multiple sclerosis</span>


In a recent study entitled “MicroRNA expression profiling of human blood monocyte subsets highlights functional differences,” a team of researchers discovered a pool of 66 microRNAsthat underlie differences in phenotype and function of a group of immune cells with key roles in multiple sclerosis. The study was published in the journal Immunology.
Within human blood, a panoply of immune cells play key roles in defending us from foreign pathogens and also from cells that go wrong, such as cancer cells. Monocytes are a class ofwhite blood cells accounting for 5% to 10% of all immune cells, and are key players at destroying viruses and bacteria, but also at acting as intermediaries to alert other immune cells to potential threats. We have two subsets of monocytes, according to the differential expression of a surface molecule called CD16.
CD16 positive cells are a particularly important group of immune cells with high levels inmultiple sclerosis but also in infectious diseases, such as HIV, and inflammatory conditions like sepsis. Notably, however, the mechanism underlying the two subsets of CD16 cells remains unknown, as Dr. Siew Cheng Wong of the Singapore Immunology Network at theAgency for Science, Technology and Research (A*STAR), and study lead author, noted in a press release: “Nobody really knows the function of these cells or the consequence of this cellular expansion during disease processes. Are these cells helping to control disease or does the expansion of these cells contribute to the pathogenesis?”
Read More


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Microchips May Be New Standard in Multiple Sclerosis Studies

Chip technology could replace cell cultures to further disease understanding, researchers


<span class="entry-title">Microchips May Be New Standard in Multiple Sclerosis Studies</span><span class="entry-subtitle">Chip technology could replace cell cultures to further disease understanding, researchers say</span>


In a new article published in the journal Trends in Biotechnology, Korean researchers suggest that diseases of the central nervous system (CNS) might be better studied using compact, accessible chip technology than in current methods. The report, titled Central Nervous System and its Disease Models on a Chip, appeared on Oct. 20, 2015.
The study of multiple sclerosis (MS) may advance via use of microchip systems because these platforms could serve as mini-brains, complete with neurons, supporting cells known as glia, and connected neuronal circuitry. Unlike a traditional “cell culture,” scientists can arrange cells on chips in an organized fashion, instead of simply growing them in a dish.
Chip “systems have been rapidly progressing over the past decade, enabling the development of unique microplatforms for in vitro human central nervous system (CNS) and related disease models,” the researchers note. Such platforms might, for example, help scientists to understand myelin loss and how to prevent it.
In MS, neurons lose myelin, the fatty substance that wraps around nerve connectors (axons) and helps promote  communication within the nervous system. When myelin deteriorates, individuals may experience symptoms such as movement loss, vision problems, coordination loss and sensory problems.

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Sunday, November 8, 2015

Clinical question: Is there any difference between oral and intravenous methylprednisolone for multiple sclerosis relapses?


Oral Steroids Not Inferior to Intravenous Steroids in Multiple Sclerosis Relapses


Background: When relapses of multiple sclerosis occur, studies have shown that intravenous steroids are the treatment of choice. Prior Cochrane meta-analyses have not found any significant difference between intravenous and oral treatments; however, the studies all have had limitations. This study was designed to provide a statistically significant answer.
Study design: Randomized, double-blinded, noninferiority trial.
Setting: Thirteen multiple sclerosis centers in France.
Synopsis: Patients were selected if they had had a relapse within the previous 15 days; the mean time was seven days. One hundred patients were in the oral steroid group, and 99 were in the intravenous steroid group. Each group received 1 g of methylprednisolone daily for three days. In addition, each group received saline infusions or placebo capsules to keep the study blind.
After 28 days, 81% of the oral group and 80% of the intravenous group had improvements of their symptoms. Side effects from the medications were similar as well.
The study was limited by the fixed dosing (1 g daily) that was not bioequivalent. Also, MRIs, although not always used in relapses, could have added more objective information, as everyone was followed clinically using the Kurtzke Functional System Scale.
Bottom line:   Click here to continue reading 

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