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Saturday, October 10, 2015

Genzyme Provides Update on Lemtrada for Patients with Relapsing-Remitting Multiple Sclerosis, ECTRIMS 2015

Genzyme, a Sanofi company, recently announced novel positive 5-year experimental data from the extension study of Lemtrada® (alemtuzumab) in individuals with relapsing-remitting multiple sclerosis (RRMS). The findings were presented today, October 9, at the31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.
Genzyme Provides Update on Lemtrada for Patients with Relapsing-Remitting Multiple Sclerosis, ECTRIMS 2015

Lemtrada® (alemtuzumab), developed by Genzyme, is a monoclonal antibody that binds to CD52, a protein present on T and B cells. It has been suggested that these immune cells play a crucial role in the inflammatory process that occurs during multiple sclerosis (MS). It’s not clear the mechanism of action of alemtuzumab, but it seems to work by depleting circulating T and B lymphocytes. Eventually the lymphocyte populations will reconstitute, however, this replenishment is variable and depends on the subtypes of lymphocyte .
“The five-year data announced today are exciting and important for people living with relapsing MS” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business in a press release. He added that Lemtrada is a potential alternative therapy for patients that suffer from MS.
The Phase III trials for Lemtrada were randomized, rater-blinded, two-year pivotal studies. The studies compared Lemtrada therapy with a high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS with active disease that were either treated for the first time (CARE-MS I) or were unresponsive to another treatment (CARE-MS II). Both in CARE-MS I and II, Lemtrada was considerably more efficient than interferon beta-1a at reducing annualized relapse rates, however, there was no significant difference between the two drugs in slowing disability progression. In CARE-MS II, Lemtrada significantly decrease the rate of accumulation of disability when compared with interferon beta-1a.
For the extended CARE-MS I and II, i.e. years three, four and five, patients had to have at least one or two relapses or new or enlarging brain or spinal cord lesions. During these studies, patients treated with Lemtrada showed low annualized relapse rates and had no evidence of MRI disease activity. Importantly, in the fifth year of the trials, 80% and 76% of the patients treated with Lemtrada  in CARE-MS I and II, respectively, did not show aggravation of disability progression assessed by the Expanded Disability Status Scale (EDSS). Additionally, 33% and 43% of the patients with some disability before treatment in CARE-MS I and II, respectively, showed improvement in EDSS score. Also, the patients showed a decrease in brain atrophyHowever, during the clinical trials, the therapy with Lemtrada induced serious adverse effects associated with infusion-associated reactions, autoimmune disorders (such as thyroid disease, autoimmune cytopenias, and nephropathies), infections and pneumonitis.
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COMPLETE this global employment survey to find out how MS affects employment

The MS International Federation (MSIF) is fielding a global employment survey to find out how MS affects employment. The results will be shared in a report for World MS Day (the end of May). 


If you live with MS or care for someone who does, the MS community needs to hear from you! 

This short survey will help us better understand how MS affects employment around the world. 

Results will be included in a report for World MS Day 2016 and will help us increase awareness and communicate with legislators and employers about how they can help people living with MS to remain in the workforce.

  Take the survey today!







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LAST CHANCE to REGISTER for 2015 EPIC MS Symposium in South Florida designed by MS Patients FOR MS Patients and Caregivers






IF not yet registered to attend this event, 
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PPMS Update: Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis

  • Ocrelizumab showed superiority to interferon beta-1a (Rebif®) in two identical Phase III studies in people with relapsing multiple sclerosis (MS), the most common form of the disease
  • Ocrelizumab is the first investigational medicine to show efficacy in people with primary progressive MS in a large Phase III study
  • Ocrelizumab Phase III data will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 7-10 in Barcelona, Spain

Genentech, a member of the Roche group, today announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Data from two identical studies (called OPERA I and OPERA II) in people with relapsing MS, which affects approximately 85 percent of people with MS at the time of diagnosis, showed ocrelizumab was superior to interferon beta-1a (Rebif®), a well-established MS therapy, in reducing the three major markers of disease activity over the two-year controlled treatment period.

In a separate study (called ORATORIO) in people with PPMS, a form of the disease marked by steadily worsening symptoms and typically without distinct relapses or periods of remission, ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks (the primary endpoint) and 24 weeks (a secondary endpoint) compared with placebo. Additionally, the study met other secondary endpoints of reducing the time required to walk 25 feet, the volume of chronic inflammatory brain lesions, and brain volume loss.


South San Francisco, CA -- October 8, 2015 --

Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY) today announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Data from two identical studies (called OPERA I and OPERA II) in people with relapsing MS, which affects approximately 85 percent of people with MS at the time of diagnosis, showed ocrelizumab was superior to interferon beta-1a (Rebif®), a well-established MS therapy, in reducing the three major markers of disease activity over the two-year controlled treatment period.

In a separate study (called ORATORIO) in people with PPMS, a form of the disease marked by steadily worsening symptoms and typically without distinct relapses or periods of remission, ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks (the primary endpoint) and 24 weeks (a secondary endpoint) compared with placebo. Additionally, the study met other secondary endpoints of reducing the time required to walk 25 feet, the volume of chronic inflammatory brain lesions, and brain volume loss.


“The results of these three pivotal trials have the potential to transform the treatment of MS,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Ocrelizumab is the first investigational medicine to significantly reduce disability progression in people with relapsing MS and people with primary progressive MS – a form of MS with no approved treatments. We are eager to work with regulatory authorities to bring this investigational medicine to the MS community as soon as possible.”

“These results redefine our understanding of MS by highlighting the central role of the B cell,” said Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies and chair of the Department of Neurology at the University of California San Francisco School of Medicine. “The findings may also encourage the MS community to look more closely at earlier treatment of the disease. Currently, many doctors reserve what are considered highly effective MS medicines until a patient’s disease becomes more advanced. Patients and their doctors need new treatment options that offer the potential for greater efficacy than a standard-of-care interferon with a similar safety profile.”




The entire press release is attached and can also be found here: http://www.gene.com/media/press-releases/14609/2015-10-08/genentechs-ocrelizumab-first-investigati



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Ocrelizumab Proven Effective In Multiple Sclerosis Treatment for Primary Progressive MS (PPMS)

Successful clinical trial results by Bay Area researchers was released Thursday on a new drug that shows promise to become the first drug to treat a devastating progressive form of multiple sclerosis (MS). Roche Holding AG’s Genetech unit announced that the experimental drug ocrelizumab proved effective in three studies against MS, reports The Wall Street Journal. The findings in the late-phase trials of ocrelizumab find that the drug greatly reduces symptoms for progressive MS as well as a more common form of the degenerative disease, known as relapsing and remitting multiple sclerosis, which affects nearly 85 percent of MS patients.



Ocrelizumab Proven Effective In Multiple Sclerosis Treatment


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Biometrica MS Launched at ECTRIMS 2015 to Support Routine Multiple Sclerosis Care

Biometrica MS Launched at ECTRIMS 2015 to Support Routine Multiple Sclerosis Care


Biometrica MS®, a technology that provides an easy to use service for neurologists to quantify lesion load as well as brain volume measures in clinical practice, is a web-based image analysis tool that was recently launched at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), a conference that is being held this week in Barcelona, Spain (October 7 – 10, 2015).
A variety of clinical information including cut-off points, as established by data from phase II and III studies, can be applied to Biometrica MS® to benefit the assessment of patients with multiple sclerosis (MS) in routine care.
Continue reading



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Could I Have MS?

Maybe you’ve felt exhausted or weak lately. Or your foot is starting to tingle. So you do a quick Internet search and come up with an alarming result: Your symptom is one of the signs of multiple sclerosis (MS), a disease of the brain and spinal cord.

Before you start to worry, know that many signs of the condition are the same as symptoms of other health problems. So it’s easy to mistake another issue for MS, which affects less than 1% of Americans.

How can you tell if what you’re feeling is caused by MS or something else? First, keep in mind that most people have the first signs of the disease between the ages of 20 and 40. You can also keep track of your problems: MS symptoms tend to come and go or get worse over time.

It helps to know what else can explain some of the signs you might be feeling.




Click the above links to learn more





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Monday, October 5, 2015

Smoking an MS Risk Factor Among MS Patients' Relatives


CHICAGO -- Cigarette smoking is a risk factor for developing multiple sclerosis among first-degree relatives of confirmed MS patients, according to an ongoing study of more than 2,600 such individuals.


The study, based on a model combining genetic and environmental risk factors to identify likelihood of developing MS, found in 1,696 first-degree relatives of MS patients (113 with MS themselves) that smoking is associated with MS susceptibility (P=0.0096), said lead study author Zongqi Xia, MD, PhD, of Brigham and Women's Hospital in Boston.


The work, presented here at the American Neurological Association's annual meeting, did not find an association between infectious mononucleosis and risk of MS (P=0.39) -- of interest because past studies have linked MS to exposure to Epstein-Barr virus, which causes infectious mononucleosis.

The investigators found the incidence of MS in this population to be 123 per 100,000 -- a rate that is 20 to 30 times higher than that of the general population, Xia said. Consequently, the model holds promise for identifying individuals at the highest risk of developing MS who could be good candidates for prevention efforts.
Continue

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Multiple Sclerosis Could Be Treated With a Surprise Medication

An already approved medication used for bladder problems might help to treat multiple sclerosis, according to researchers at the State University of New York at Buffalo.
Lead author Fraser J. Sim, PhD, Assistant Professor in the Department of Pharmacology and Toxicology in the University at Buffalo School of Medicine and Biomedical Sciences stated “We have identified a new drug target that promotes stem cell therapy for myelin-based disease, such as MS.”
The research appeared in the Journal of Neuroscience and was funded by the National Multiple Sclerosis Society, the Kalec Multiple Sclerosis Foundation and the Empire State Stem Cell Fund.
The medication is called solifenacin, which has already been approved by the federal drug administration (FDA) to treat overactive bladder. The drug targets a receptor for the neurotransmitter acetylcholine, known as the muscarinic receptor. It could also act on cells that remyelinate the nerves of the body. Myelin is the fatty substance that wraps around neurons and is damaged in multiple sclerosis due to an autoimmune attack. Oligodendocytes are specialized cells that produce the myelin.
“Our hypothesis is that in MS, the oligodendrocyte progenitor cells seem to get stuck,” Sim noted. “When these cells don’t mature properly, they don’t differentiate into myelinating oligodendrocytes.”
In the study, Sim and his coworkers studied the molecular pathways that control how oligodendrocyte cells formed. Then they tried to identify drugs that could change how much myelin the oligodendrocytes produce.

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Creating Life Balance with MS - a Video presentation by Jessica Thomas, LCSW


WATCH, LEARN and Share this video presentation that helps you to Fit MS into Your life



Jessica's talk begins approx 5-1/2 minutes into this video




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Find a Lemtrada Learning Program-event near you

> 
Learn what an expert has to say about an infusion treatment for relapsing MS
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LEMTRADA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).
LEMTRADA live events start now.
Attend an MS event near you to learn more about LEMTRADA, an infusion treatment for relapsing MS.
If you or someone you know has relapsing MS, it can help to hear information about treatment options. That's why we're letting you know about upcoming free MS events in your area. Join us to hear from an MS expert about LEMTRADA, an infusion treatment for relapsing MS.
IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including:
Serious autoimmune problems: Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include:
Immune thrombocytopenia, which is when reduced platelet counts in your blood cause severe bleeding that, if not treated, may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; heavier menstrual periods than normal; bleeding from your gums or nose that is new or takes longer than usual to stop; small, scattered spots on your skin that are red, pink, or purple
Kidney problems called anti-glomerular basement membrane disease, which can, if untreated, lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: blood in the urine (red or tea-colored urine); swelling of legs or feet; coughing up blood
It is important for you to have blood and urine tests before you receive, while you are receiving and every month, for 4 years or longer, after you receive your last LEMTRADA infusion.
Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.
You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.
Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:
swelling in your mouth or throat
trouble breathing
weakness
fast, slow, or irregular heartbeat
chest pain
rash
To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them after they happen.
Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:
new lump
swelling in your neck
pain in front of neck
hoarseness or other voice changes that do not go away
trouble swallowing or breathing
cough that is not caused by a cold
Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.
Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.
Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:
excessive sweating
unexplained weight loss
eye swelling
nervousness
fast heartbeat
unexplained weight gain
feeling cold
worsening tiredness
constipation
Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as:
weakness
chest pain
yellowing of the skin or whites of the eyes (jaundice)
dark urine
fast heartbeat
Serious infections: LEMTRADA may cause you to have a serious infection while you receive and after receiving a course of treatment. Serious infections may include:
Herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take any medicines as prescribed by your healthcare provider to reduce your chances of getting these infections.
Tuberculosis. Your healthcare provider should check you for tuberculosis before you receive LEMTRADA.
Hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.
These are not all the possible infections that could happen while on LEMTRADA. Call your healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.
Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:
shortness of breath
cough
wheezing
chest pain or tightness
coughing up blood
Before receiving LEMTRADA, tell your healthcare provider if you:
are taking a medicine called Campath® (alemtuzumab)
have bleeding, thyroid, or kidney problems
have HIV
have a recent history of infection
have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine
are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby. You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should receive LEMTRADA or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.
The most common side effects of LEMTRADA include:
rash
headache
thyroid problems
fever
swelling of your nose and throat
nausea
urinary tract infection
feeling tired
trouble sleeping
upper respiratory infection
herpes viral infection
hives
itching
fungal infection
joint pain
pain in your arms
or legs
back pain
diarrhea
sinus infection
mouth pain or sore throat
tingling sensation
dizziness
stomach pain
sudden redness in face, neck, or chest
vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA- 1088.
Please click here for full Prescribing Information, including serious side effects and Medication Guide, for additional Important Safety Information.
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