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Tuesday, June 30, 2015

Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis

June 30, 2015


  • Studies showed superiority on primary and major secondary endpoints in people with relapsing forms of multiple sclerosis
  • Genentech will submit data to the U.S. Food and Drug Administration
  • Phase III study in primary progressive multiple sclerosis ongoing
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from two pivotal studies evaluating the investigational medicine ocrelizumab compared with interferon beta-1a (Rebif®), a standard-of-care therapy, in people with relapsing multiple sclerosis (MS), the most common form of the disease. The studies (called OPERA I and OPERA II) met their primary and major secondary endpoints.
Treatment with ocrelizumab significantly reduced the annualized relapse rate (ARR) over a two-year period compared with interferon beta-1a, the primary endpoint in both studies. Ocrelizumab also significantly reduced the progression of clinical disability compared with interferon beta-1a, as measured by the Expanded Disability Status Scale (EDSS).
Additionally, treatment with ocrelizumab led to a significant reduction in the number of lesions in the brain (areas of disease activity) compared with interferon beta-1a, as measured by MRI.
Overall, the incidence of adverse events associated with ocrelizumab was similar to interferon beta-1a in both studies; the most common adverse events were mild-to-moderate infusion-related reactions. The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to interferon beta-1a.
“Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to U.S. and EU regulatory authorities in the first quarter of 2016.”
Further analyses of the OPERA studies are ongoing and detailed data will be presented at an upcoming medical congress.
Results from a Phase III study of ocrelizumab in people with primary progressive MS (PPMS), a different form of MS, are expected later this year.
About the OPERA Studies
OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of ocrelizumab (600 mg dose administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg dose administered by subcutaneous injection three times per week) in people with relapsing forms of MS.1 The primary endpoint of the OPERA studies was annualized protocol-defined relapse rate (ARR) at two years (96 weeks). Secondary endpoints included time to onset of confirmed disability progression, the total number of T1 Gadolinium-enhancing lesions, and total number of new and/or enlarging T2 hyperintense lesions as detected by brain MRI.
The OPERA I and OPERA II studies enrolled a total of 1,656 people with relapsing forms of MS (i.e., relapsing-remitting MS and secondary-progressive MS with relapses) across 307 sites in 40 countries.
About ocrelizumab
Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells. Therefore the ability to make new B cells is preserved in people treated with ocrelizumab.
The Phase III clinical development program for ocrelizumab includes the OPERA I and OPERA II studies in people with relapsing forms of MS, as well as ORATORIO, a randomized, double-blind, global multi-center, placebo-controlled study in people with PPMS.2
About Genentech in Neuroscience

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Hadassah Conducts Unprecedented Trial of Stem Cell Treatment for MS

June 25, 2015


Prof. Dimitrios Karussis, head of Hadassah Medical Organization’s Multiple Sclerosis Center

An unprecedented clinical trial launched at the Hadassah Medical Organization, which will test the effectiveness of a treatment for Multiple Sclerosis (MS) involving multiple injections of enhanced stem cells directly into the cerebrospinal fluid, could bring hope to the 2.5 million patients worldwide suffering from this neurodegenerative disease.
The trial, under the direction of Prof. Dimitrios Karussis, head of Hadassah’s Multiple Sclerosis Center, is a large randomized double-blind, placebo-controlled study that will eventually have 48 MS patients. While the patients in the control group will not know if they are initially getting the actual treatment or a placebo, the trial contains a crossover design so that eventually everyone will get the stem cell treatment, although some patients will receive the actual treatment six months later.
The novel concept of injecting the stem cells directly into the spinal fluid is aimed at getting the cells to circulate to the various damaged areas of the central nervous system. The injected stem cells, explains Prof. Karussis, “are at their preliminary stage of maturity,”  having the potential to renew the damaged myelin, the nerve covering that degenerates in MS, as well as to suppress the disease. “The cell renewal process,” he says, “will not only prevent future MS attacks, but will also significantly improve motor and cognitive functions which were previously affected by MS, including walking, memory, and more. Preliminary results of our trial have seen wheelchair-bound patients getting back on their own two feet.”
Prof. Karussis hopes to have an interim analysis of the results within one year; the study is intended to be completed at the end of 2016 or early 2017.
“This is truly a groundbreaking trial on a worldwide scale,” concludes Prof. Karussis. “The various unprecedented components of the trial, including the multiple subjects, unique injection technique, and double-injection hope to pave the way to a new form of treatment for MS.
SOURCE



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The Burden of Disease A closer look at the consequences of living with multiple sclerosis


Click to open this .pdf document which will provide you with lots of information concerning the title of this posting
---  http://msatrium.com/pdf/Burden_of_disease_MS_atrium.pdf







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Dear Dealing with Cabin Fever, have you considered arts and crafts?

Dear Nurse,
I've been out of work for two months now due to my latest flare. I lost my job when it hit, so I have nothing to go back to. I have definitely been getting better, but due to the fact that my profession requires me to be on my feet quite a bit, I'm not ready to start applying for jobs yet. Any other jobs don’t seem to fit my financial needs or experience.
I never thought I would miss work, but I am bored out of my mind from sitting at home every day! I definitely need the money, but it is so much more than that right now. I miss the daily interaction with my coworkers and feeling like I actually do something.
I live alone and I've always loved it before, but five days a week with absolutely no human interaction is getting to me. I go between my TV and my computer all day long, every day. I used to enjoy browsing at stores on my days off, but now that just feels like a waste of gas and reminds me of everything I can't have.
I just don't know what to do anymore. How can I keep myself from going crazy when I can't do anything like I used to do?
Sincerely,
Dealing with Cabin Fever
Dear Dealing with Cabin Fever,
Well, I think it’s very important that you make an effort to get out of the house. You don’t want this to continue and have it feel harder and harder to overcome. Call up some of your friends or family and ask them to have lunch or go to the movies. One or two outings a week could be helpful. Maybe there’s a hobby you used to enjoy that you haven’t had time for? Is there something you’ve always wanted to try?
Another option is to check out what kind of organized activities are happening in your area. For example, many local craft stores have classes available and many of them are free. An activity like that would not only get you out of the house and give you a project to focus on, but it may also give you an opportunity to make some new friends.
Another thing I would recommend is checking with your local or national MS society to see if there are any job-training programs available that might interest you. It may be that you can find employment in a position that’s a better fit for your current situation. One of the resources that I give to some of my patients is called A Guide for People with Disabilities Seeking Employment. This may be very helpful to you as far as getting some retraining for another position when you are ready to go back and look for work.
I wish you well and hope that things work out for you.
— Nurse Janie, MS One to One Nurse
Janie

see more found here


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Does Having MS Put You in a High Risk Pregnancy Category?

AIMS (Advances In Multiple Sclerosis)<br />
Regional Meeting Series


  Panel Discussion, Now Available On-Demand!

Special Considerations for the Overall Health Care Management of the Female Patient with MS – Earn CME/CNE!
Listen to this multispecialty event to learn about challenges, best practices, and special considerations specifically related to women with MS.
launch webinar
Discussion topics include:
  • Family Planning
  • Managing Pregnancy
  • Breastfeeding
  • Menopause
  • OB/GYN Approach to MS Patients
PANELISTS
Patricia K. Coyle, MD

Professor of Neurology and Vice Chair of Clinical Affairs
Director, MS Comprehensive Care Center
Stony Brook University

Jacqueline Bernard, MD
Assistant Professor of Neurology
University of Chicago Medical Center

Men-Jean Lee, MD
Associate Professor
Beth Israel Medical Center
Mount Sinai School of Medicine




  Patient Communication Tools – Coming Soon!

Patient Communication Tools will be printable, one-page educational sheets with critical information, tips, and useful links for your patients. Topics will include:

  • Bone Mineral Density Testing/Osteoporosis Risk Screening
  • Reproductive Health/Family Planning
  • Contraception
  • Menopause
  • Infertility
  • Breastfeeding
  • Sexual Dysfunction
  • Optimizing the Office Visit
Coming soon to www.cmeAIMS.org!



  CME/CNE Videos Available

Contraceptive Techniques
Presented by: Joy A. Derwenskus, DO and Susan Rubin, MD
Launch video >

Pregnancy and the MS Patient: Pre-Pregnancy through Post-Partum

Presented by: Patricia K. Coyle, MD and Jacqueline Bernard, MD
Launch video >

Menarche, Menstruation, Menopause, and MS

Presented by: Jacqueline Bernard, MD and Patricia K. Coyle, MD
Launch video >

Key Considerations for the MS Patient and Breastfeeding

Presented by: Patricia K. Coyle, MD and Jacqueline Bernard, MD
Launch video >

Diagnosis and Management of Sexual Dysfunction

Presented by: Susan Rubin, MD and Jacqueline Bernard, MD
Launch video >





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Monday, June 29, 2015

Novartis’ Gilenya Found to Have Long-Term Positive Effects on Patients with Relapsing-Remitting Multiple Sclerosis

A new study recently published in the Journal of Neurology, Neurosurgery and Psychiatryrevealed that long-term fingolimod therapy (marketed as Gilenya by Novartis) can maintain a low disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The study was conducted by an international team of researchers and is entitled “Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomized TRANSFORMS study.
Multiple sclerosis is a chronic, progressive neurodegenerative disorder that results from an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects neurons resulting in motor function impairment (coordination, balance, speech and vision), irreversible neurological disability and paralysis. It is estimated that more than 2.3 million people in the world suffer from MS, and 400,000 in the U.S. alone have the disease. The most frequent form of the disease is RRMS, which is clinically characterized by recurring episodes of neurological symptoms.
Fingolimod is an immunomodulating drug and an effective therapy for RRMS. The safety, tolerability and efficacy of two oral doses of fingolimod (0.5 or 1.25 mg once daily) were assessed in the 12-month, randomized, double-blind phase 3 clinical trial called TRANSFORMS (NCT00340834) in RRMS patients in comparison to treatment with interferon (IFN) beta-1a. The study revealed that fingolimod therapy at both doses significantly improved clinical and magnetic resonance imaging (MRI) outcomes with patients experiencing a reduction in the frequency of relapses in comparison to IFN beta-1a treatment.


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SHARED SOLUTIONS® - offering many services for the MS Patient


SHARED SOLUTIONS®

Support and partnership you can trust

Managing relapsing MS begins with living a healthy lifestyle and committing to a therapy that’s right for you. Having a team of people to help you may make things easier. That's where Shared Solutions® comes in.

A network of MS support from Day 1

CALL A MS-CERTIFIED NURSE

Shared Solutions® is a comprehensive network of free resources available to people with MS, CarePartners, friends, family, and anyone else who has been touched by MS. Shared Solutions® is here to support you wherever you are in your treatment experience, no matter which therapy you choose. Once you are enrolled with Shared Solutions®, a Case Manager will contact you to ensure that you have the personalized plan and assistance that you need to get started and stay on COPAXONE®.
Learn how Shared Solutions® provides the support, knowledge, and answers you need to help you get started on relapsing MS therapy—and stay committed to the therapy you choose.
Our offerings include:
Free in-home injection and refresher training
Feel confident and comfortable with your injections from the start...and throughout your COPAXONE®therapy experience. Our injection training nurses receive ongoing training, and can provide you with tips and techniques that can improve your injection experience.
24/7 phone support from MS-certified nurses
MS-certified nurses are available around the clock at our call center to answer your questions and provide the support you need, whether you have just been diagnosed or have been managing relapsing MS for some time.
Insurance and benefits investigation
Shared Solutions® believes that financial matters should not get in the way of your relapsing MS treatment.
Financial solutions
COPAXONE Co-pay Solutions® may be able to help you lower your co-pay for 3-times-a-weekCOPAXONE® 40 mg to $0 per month†† out of pocket. Benefits specialists at Shared Solutions® can help find personalized financial solutions to help you start and stay on COPAXONE® therapy.

Terms and Conditions
MS Peer* program
Shared Solutions® can make one-on-one support possible by matching you with an MS Peer* with whom you may share similar experiences and circumstances. Share your feelings, discuss important issues, and hear encouraging words from someone else with relapsing MS.
Live events
Stay in tune, informed, and in touch through events and support programs that connect you with the relapsing MS community and your peers.
National teleconference series
Call in to informative and educational relapsing MS programs hosted by leading MS experts.
And…
Free delivery of COPAXONE® refills right to your door

Shared Solutions® can help arrange home delivery service to qualifying patients.

Your Case Manager will get you started



  Our offerings include:   Click here to learn more


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Sunday, June 28, 2015

MS and Heat Sensitivity: I Thought I Knew What to Do

TREVIS now knows "HEAT"


Published Jun 26, 2015
It’s always nice to come home after being away for a few weeks.  It was particularly pleasant to return home to an 85°F temperature change.
On a recent leg of my book release tour, the hottest day while I was in South Carolina was 103°F  with humidity closer than a hoarder’s cupboard. By the end of nearly two weeks in the South, mymultiple sclerosis and I now fully understand what heat can do to us.
I’ve gone on about MS and heat sensitivity and thought that I had a good plan. My plan went out the window when air-conditioning in a car in which I was riding couldn’t keep up with the heat during a seven-hour drive. I arrived in South Carolina from Florida with muscle rigidity in my left arm, a stammer in my speech, and a droop on the left side of my face, and my left leg and foot were worthless to me.
For seven days the temps spiked to above 100°F. The pool of the rental house never dropped below body temperature, and palmetto palms are beautiful but offer little shade.
Cool – cum cold – showers were required at least (and usually more than) three times each day. Mid-afternoon naps became mid-morning, mid-day, and mid-afternoon rests under whirling ceiling fans blowing the air conditioning down on my body.
I don’t know how our brothers and sisters of the hotter climates handle such intense heat coupled with hair-curling, mind-numbing humidity.
I will say that even though I had some new muscle stiffness due to the heat-induced pseudo-exacerbation, the heat did seem to soothe the pain normally associated with such rigidity.


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Finding Hope: Lakeland Woman Recovering From Experimental Treatment for MS

FROM LEFT, Nolen Baker, 4, Steve Baker, Lincoln Baker, 1, and Kristan Baker at their home in Lakeland.
PIERRE DUCHARME | THE LEDGER
Published: Saturday, June 27, 2015 at 10:59 p.m.
Last Modified: Saturday, June 27, 2015 at 10:59 p.m.
The scariest moment for Kristan Baker came one day last fall as she walked through a Target store holding hands with her toddler son, Nolen. Baker lost her balance and tumbled down face-first, dragging Nolen with her.
Such accidents are a constant possibility for Baker, who was diagnosed 11 years ago with multiple sclerosis. The Lakeland resident has seen her physical decline accelerate since she gave birth to Nolen nearly four years ago.
Baker, 34, has gone from racing in triathlons to worrying she won't be able to catch up to her 1-year-old son, Lincoln, if he dashes toward the street.
"I've got numbness over about 75 percent of my body, and what I feel isn't normal," Baker said. "My feet either feel like they're on fire or they're soggy sponges. I feel like I'm walking on rocks some times. Touch with cold hands takes my breath away; it's painful."
There is no known cure for MS, an autoimmune disease in which the nerves of the brain and spinal cord degenerate, causing a progressive loss of bodily control. Yet Baker is in the midst of an experimental treatment she hopes will halt her decline.
Baker expects to return home today following treatment at Northwestern University's Feinberg School of Medicine that involved chemotherapy and a transplant of her own stem cells. Richard K. Burt, a doctor at the school's Division of Immunotherapy and Autoimmune Diseases has pioneered the protocol, now in the third phase of a clinical trial, to treat multiple sclerosis and other autoimmune disorders.
The treatment essentially resets the patient's immune system to the way it worked before the onset of multiple sclerosis.
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Friday, June 26, 2015

"CROSSFIRE" – A Very Informative Multiple Sclerosis Q&A Program, from Tampa, Florida



 This is  Very Informative Multiple Sclerosis  Q&A session with next generation MS Neurologists who 'tell it like it is'

  WATCH, LISTEN, Learn and Share, to help others learn from this program...



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Speech and Swallowing Problems From MS

People with multiple sclerosis, or MS, often have trouble swallowing, a problem called dysphagia. It can also lead to speech problems. It happens when the disease damages the nerves in the brain and spinal cord that make these tasks happen.
For some people, these problems are mild. Others have a harder time dealing with severe symptoms. But treatments and techniques can help you improve your speech and make swallowing easier.

Symptoms of a Swallowing Problem

You might:
  • Cough or choke when you eat
  • Feel like food is lodged in your throat
  • Get a lot of lung infections, like pneumonia, that you can’t explain
When you can’t swallow properly, you might inhale food or liquids into your windpipe instead of getting them down your esophagus and into your stomach. Once in the lungs, they can cause pneumonia or abscesses. You could also be at risk for malnutrition or dehydrationbecause your food and water aren’t getting to your stomach.

Symptoms of Speech Problems

The kinds of speech problems MS causes can vary depending on which part of the brain is damaged. Someone with the disease might have mild trouble with words or severe problems that make it hard for them to speak and be understood. A problem that’s subtle in the beginning might get worse over time.
People with MS usually have a few distinctive language problems:
  • “Scanning" speech, when a person’s normal speech pattern is disrupted with long pauses between words or syllables
  • Slurring words. It usually happens because of weak tongue, lip, andmouth muscles.
  • Trouble changing tone of voice
  • Nasal-sounding speech

Getting a Diagnosis

Your doctor will ask you about your symptoms and do a physical exam, paying attention to how well your tongue and other muscles in yourmouth and throat work.
In some cases, your doctor may recommend that you get a test called a modified barium swallow. You’ll drink a special liquid that coats your throat, stomach, and small intestine, and your doctor will give you an X-ray. The fluid makes your insides stand out on the image. The test helps your doctor pinpoint where and why you’re having trouble swallowing.

Your doctor might suggest that you see a speech therapist or a speech-language pathologist. She can figure out which part of your speech is affected and study your breathing control and way you move your lips, tongue, and other parts of your mouth.
Continue reading direct from WebMD


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