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Saturday, October 12, 2013

Cerebrospinal Venous Insufficiency Rare in Multiple Sclerosis


Cerebrospinal Venous Insufficiency Rare in MS, Controls
Cerebrospinal Venous Insufficiency Rare in MS, Controls
(HealthDay News) – Chronic cerebrospinal venous insufficiency is rarely observed in those with multiple sclerosis, their unaffected siblings, or controls, according to a study published online Oct. 9 in The Lancet.
Anthony L. Traboulsee, MD, from the University of British Columbia in Vancouver, Canada, and colleagues conducted a case-control, multicenter study involving 177 adults to establish the prevalence of venous narrowing in those with multiple sclerosis (79 participants), unaffected full siblings (55 participants), and unrelated healthy volunteers (43 participants). Catheter venography and ultrasound criteria for chronic cerebrospinal venous insufficiency were used to assess narrowing of the internal jugular and azygous veins (data for 149 and 171 participants, respectively).
The researchers found that, based on catheter venography criteria, 2% of those with multiple sclerosis, 2% of siblings, and 3% of unrelated controls were positive for chronic cerebrospinal venous insufficiency (P=1 for all comparisons). More than 50% narrowing of any major vein was seen in 74, 66, and 70%, respectively. The ultrasound criteria for chronic cerebrospinal venous insufficiency were fulfilled by 44% of those with multiple sclerosis, 31% of siblings (P=0.15), and 45% of unrelated controls (P=0.98).
Source: Medical Xpress


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Three Major Advances in Multiple Sclerosis - Discussed at ECTRIMS 2013

ECTRIMS : European Committee for Treatment and Resources in Multiple Sclerosis


Three Major Advances in Multiple Sclerosis



Andrew N. Wilner, MD, Fred D. Lublin, MD, Robert J. Fox, MD
DisclosuresOct 10, 2013







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Genmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple Sclerosis

Oct 10, 2013

Genmab A/SCompany AnnouncementGenmab Announces Positive Top-Line Phase II Results of Ofatumumab in Multiple
SclerosisCompany Announcement

  -- Treatment with ofatumumab showed significant reduction in the cumulative
     number of new brain lesions
  -- No unexpected safety findings

Copenhagen, Denmark; October 10, 2013 -- Genmab A/S (OMX: GEN) announced today
top-line results from a Phase II study of the subcutaneous formulation of
ofatumumab in relapsing-remitting multiple sclerosis (RRMS).

A total of 232 subjects with RRMS were randomized in the study.  There was a
clear separation from placebo on the cumulative number of new gadolinium
enhancing lesions (active brain lesions) over a period of 12 weeks in subjects
treated with all doses of ofatumumab compared to subjects treated with placebo
[p < 0.001].  For the primary endpoint, analysis of data from weeks 0-12
estimated a 65% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all doses [p < 0.001].  In weeks 4-12, analyses of data
estimated a >= 90% reduction in the cumulative number of new T1 gadolinium
enhancing lesions for all cumulative doses of ofatumumab >= 30 mg [p < 0.001].

There were no unexpected safety findings in the study.  From weeks 0-12,
injection related reactions were the most common adverse reaction and were
observed in 52% of subjects receiving ofatumumab compared to 15% of subjects
receiving placebo. There were five serious adverse events (SAEs) reported, all
subjects received a 60 mg dose of ofatumumab and none of these subjects
withdrew from the study. Twelve subjects withdrew during this time period; 10
of these subjects were receiving ofatumumab.  To date, no cases of progressive
multifocal leukoencephalopathy (PML) or opportunistic infections have been
observed.

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Friday, October 11, 2013

If you’re looking to learn about a different option for treating your MS relapses, you are invited to join a free online educational session where an MS healthcare professional will discuss:






·         The difference between MS relapses and pseudo-relapses
·         The importance of treating your MS relapses
·         How to talk about your MS relapses with your healthcare provider
·         An available treatment option for MS relapses
·         Insights shared by a person living with MS


Online program date:
·         Tuesday, October 29, 2013 at 7:30 PM ET
Register today by phone at 1-877-219-0410 
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Teva: Laquinimod reduces brain damage in MS patients

Teva CSO: Laquinimod might also help treat Crohn's disease, lupus nephritis, Huntington’s disease and Alzheimer’s.


Teva Pharmaceutical Industries Ltd.  and Active Biotech  today published positive results of a Phase III clinical trial of Laquinimod, an oral treatment for multiple sclerosis. The study found the drug reduced neurodegeneration, slowing the progression of locomotor disability in multiple sclerosis patients.
The study found that, compared with a placebo, patients treated with laquinimod had decreased rates in brain tissue damage shown by various MRI markers, specifically less atrophy of white matter, grey matter, and thalamic atrophy. They also developed fewer permanent black holes, and accumulated less damage in normal appearing brain tissue.
"These analyses reinforce our faith in the potential of laquinimod and we are proud to announce that we plan to initiate a clinical trial of the drug in multiple sclerosis to gather even more evidence of this novel mechanism of action,” said Teva president of Global R&D and CSO Dr. Michael Hayden. “We also believe the potential neuroprotective benefits of laquinimod could have significant application in the treatment of other diseases like Crohn's disease, lupus nephritis, Huntington’s disease and Alzheimer’s.
Teva is also conducting a third Phase III laquinimod trial to evaluate two doses of the drug in 1,800 patients for up to 24 months. The primary endpoint is the time to confirmed disability progression as measured by the EDSS. The study will also examine the laquinimod's effect on endpoints such as amount of change in brain volume, and other clinical and MRI markers of multiple sclerosis activity.
Published by Globes [online], Israel business news - www.globes-online.com - on October 1, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013


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Wednesday, October 9, 2013

New technique for imaging myelin loss and repair shows potential for identifying compounds with future potential to treat MS

Oct 03, 2013
Researchers in Cleveland and London, funded by the National MS Society have achieved a new way to visualize and monitor the loss and repair of nerve-insulating myelin over time, creating a non-invasive tool to identify compounds with future potential to treat MS. Their studies used PET (positron emission tomography) imaging in rats as a non-invasive way to detect myelin damage and its subsequent repair by an experimental compound. Yanming Wang, PhD, Chunying Wu, PhD, Robert Miller, PhD, and colleagues at Case Western Reserve University and Imperial College, London, recently reported results in the Annals of Neurology.
Background: In multiple sclerosis, myelin, the fatty substance that surrounds and protects nerve fibers, is attacked and destroyed, leading to many possible neurological symptoms. Several therapies currently under development aim at promoting myelin repair, but there is no established means of observing myelin repair over time in a non-invasive manner. MRI scans are commonly used to image disease activity in the brain, but MRI is not sensitive enough to reveal specific information about myelin damage or repair. Thus, a new imaging technique is crucial for assessing how well new therapies aimed at myelin repair work.
The study: With funding from the

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Tuesday, October 8, 2013

Test May Suggest Tysabri for More MS Patients

October 7, 2013


COPENHAGEN -- A blood test for L-selectin expression on circulating immune cells may identify multiple sclerosis patients who could safely receive natalizumab (Tysabri) despite past exposure to the JC virus, a small study presented here suggested.
All MS patients taking natalizumab who developed the rare but life-threatening brain inflammation called progressive multifocal leukoencephalopathy (PML) in the study had very low levels of L-selectin expression, which was not seen in other patients who did not develop PML or in controls, said Heinz Wiendl, MD, of the University of Muenster in Germany.
He and his colleagues at the Muenster MS clinic have begun to implement the test in patients, he told attendees at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting, using a cutoff of 30% of circulating T cells positive for L-selectin (also known as CD62L).
So far, 10 patients had levels consistently below the cutoff in repeat testing. Four stopped natalizumab after counseling, Wiendl said. One developed PML, and five others are still taking the drug but with no sign of PML so far.
A larger validating study is now underway, with 342 patients accrued so far, Wiendl said.
PML results from reactivation of latent infection with the JC virus, which is common in the general population. It has been a particular problem with natalizumab, appearing shortly after the drug was approved in 2004 and forcing it off the U.S. market until its manufacturer implemented a strict risk evaluation and mitigation strategy.
Current recommendations call for JC virus serological testing in patients prior to starting natalizumab and periodically while on the drug to detect new infections. Although a positive test is not an absolute contraindication for the drug -- it remains the standard of care for patients showing aggressive MS activity in patients taking first-line therapies -- it is to be prescribed cautiously.
PML risk in patients with JC virus infection is increased with prior immunosuppressive therapy and duration of natalizumab treatment beyond 2 years.
Natalizumab mainly targets the alpha-4 integrin protein, an adhesion molecule, as is L-selectin. Studies of T cells in blood and cerebrospinal fluid (CSF) taken from 381 patients treated at the Muenster clinics showed that alpha-4 integrin expression in CSF T cells was essentially nil in natalizumab-treated patients.
But because some type of adhesion molecule action is necessary for T cells to enter CSF, Wiendl said, the finding indicated that an alternative pathway must exist, prompting the attention to L-selectin.
Among patients with long-term natalizumab therapy who did not develop PML, a mean of 40.2% of their peripheral blood CD4-positive T cells expressed L-selectin, whereas in the eight patients who later developed PML and for whom pre-PML blood samples were available, the average was 4.6% (P<0.0001), Wiendl said.
He told MedPage Today that the most obvious use of an L-selectin test would be to identify patients with past JC virus exposure on natalizumab with relatively high T-cell expression of L-selectin, since so far they appear to be at low risk for PML.
But he noted that JC virus-negative patients could benefit as well, because their risk of PML is not zero. JC virus serology tests may miss patients with recent infection or may simply be wrong; and the condition can be caused by other viruses.
Currently, he said, the group is beginning to test patients when they have received 18 natalizumab infusions, and then every 6 months. (He said the test "is very laborious.") In patients with L-selectin positivity in less than 30% of CD4-positive T cells, a switch to other therapies is considered.

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Teva to Present Further Results of Twenty-Year Open-Label Extension Study of Glatiramer Acetate 20 mg Daily for Relapsing-Remitting Multiple Sclerosis

Glatiramer acetate (GA) 20 mg daily associated with stable disease activity over the course of the twenty-year study presented at the 29th ECTRIMS congress

JERUSALEM, Oct 03, 2013 (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. today announced further results from a long-term, open-label extension study of glatiramer acetate (GA). The extension study was designed to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, the therapeutic agent in COPAXONE(R) (glatiramer acetate injection), which is indicated for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). Detailed study results will be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark during poster session P577 on October 3, 2013.
"To our knowledge, glatiramer acetate is the only treatment for multiple sclerosis that has been prospectively studied for nearly two decades in a continuously monitored, long-term study," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd.
In this analysis of 74 patients, the cumulative annualized relapse rate (ARR) over the study period was 0.2, with 24.3 percent of patients remaining relapse-free through the entire observation period. Additionally, 63.3 percent of enrolled patients stayed below EDSS 4, while 79.5 percent stayed below EDSS 6 throughout the course of the study. Advancement to secondary progressive MS (SPMS), defined by a greater than 1.0-point EDSS progression (or greater than 0.5 for patients with baseline scores greater than 6) sustained for greater than or equal to 12 months without relapse, was seen in 35 patients (47 percent). Adverse events (AEs) leading to study discontinuation with incidence greater than one percent over the 20-year observation period were largely related to site reactions, while incidence of serious AEs were notably low, with no unexpected findings.
ABOUT THE OPEN-LABEL EXTENSION STUDY
The open-label extension study is a long-term clinical analysis of patients that participated in the original 36-month, randomized placebo-controlled U.S. Glatiramer Acetate Trial. The objective of the extension study was to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, in patients with relapsing-remitting multiple sclerosis. Ongoing patients in this study were continuously treated with glatiramer acetate 20 mg daily for a mean of 19.3 years (SD=1.3, range 18-21) with an average disease duration of 27.3 years. Baseline assessments for each patient in this pooled analysis were taken at the start of GA therapy.

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SHOP.COM Now Partners with MS VIEWS and NEWS

SHOP.COM Now Partners with MS VIEWS and NEWS 


MS Views and News is proud to announce their partnership with online powerhouse SHOP.COM.  This exciting development will not only benefit MS Views and News, but also its members who shop online!  It is truly a win-win situation.

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Sunday, October 6, 2013

Oral Presentation at ECTRIMS Congress Describes Dramatic Upregulation of Genes in Signaling Pathways Related to Myelin Sheath Production


FOR IMMEDIATE RELEASE

ENDECE Neural’s NDC-1308 Potently Enhances Remyelination in Experimental Models of Multiple Sclerosis (MS)

Oral Presentation at ECTRIMS Congress Describes Dramatic Upregulation of Genes in Signaling Pathways Related to Myelin Sheath Production

Mequon, Wisc., October 4, 2013 –  Scientists from ENDECE Neural presented preclinical data today showing that the company’s lead compound, NDC-1308, addresses one of the root causes of multiple sclerosis (MS)  by significantly inducing remyelination in nerves that have been damaged by MS. In an oral presentation at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, the ENDECE Neural researchers also reported a dramatic upregulation of genes in signaling pathways involved in myelin sheath production.

NDC-1308 works by inducing differentiation of oligodendrocyte progenitor cells (OPCs) into mature oligodendrocytes, cells that synthesize and maintain the myelin sheath that covers nerves in the brain and spinal cord, the researchers noted. By contrast, the female hormones estradiol and estriol do not exert that effect.

“Repair of the myelin sheath, called remyelination, has long been an elusive goal in the treatment of multiple sclerosis,” explained Steven Nye, Ph.D., Vice President of Discovery at ENDECE Neural. “The synthesis of NDC-1308, an estradiol analog, was inspired by observations that pregnant women typically do not experience the symptoms of MS during the third trimester. In our experiments, NDC-1308 induces remyelination in animal models of demyelination, compared to estradiol and estriol which appear to be neuroprotective but do not induce OPC differentiation.”

In his presentation, Dr. Nye described how he and his colleagues synthesized more than 40 proprietary estradiol analogs in which the core structure of estradiol had been modified, and assessed how subsets of those modifications changed the hormone’s biological activity. The researchers identified NDC-1308 as the most potent of several proprietary analogs having the ability to directly induce differentiation of OPCs into mature oligodendrocytes. NDC-1308 derives its novel biological activity from the addition of a specific alkoxyalklyl moiety to the C-6 position on the estradiol B-ring.

Dr. Nye reported the following findings:

·         A 20% increase in remyelination (compared to vehicle control) of hippocampal regions of the brain (P<0.01) was associated with a 2-week course of NDC-1308 (50 mg/Kg once daily) in a mouse model of demyelination, in which the neurotoxicant cuprizone was used to remove the myelin sheath from the axons (nerve fibers) of mice.

·         NDC-1308 caused a dramatic upregulation of key genes (5- to 75-fold) in signaling pathways involved in OPC differentiation and myelin sheath production.

·         NDC-1308 significantly induced OPCs to differentiate into mature oligodendrocytes (P<0.05).

·         NDC-1308 (3 μM/day for 4 days) enhanced remyelination in demyelinated rat brain slices visualized by staining for myelin basic protein, which was consistent with the mouse cuprizone data.

·         Prophylactic administration of NDC-1308 (10 mg/kg/day for 10 days) delayed the onset of MS symptoms and reduced the severity of MS in a mouse model of experimental allergic encephalitis (EAE) induced by myelin oligodendrocyte glycoprotein (MOG), suggesting that the compound may play a dual remyelination/anti-inflammatory role in treating MS.

“Despite its structural similarity to estradiol and estriol, NDC-1308 differs from those two female hormones by virtue of its potent induction of remyelination, as demonstrated in animal models of MS,” commented James G. Yarger, Ph.D., chief executive officer and co-founder of ENDECE Neural. “Unlike estradiol and estriol, NDC-1308 induces OPC differentiation and maturation of oligodendrocytes. We envision administration of NDC-1308 either alone or in combination with current therapeutics that target the immune response and/or inflammation associated with MS. NDC-1308 may thus fill an unmet medical need for a remyelinating therapy in MS, one that may help improve the lives of patients living with this devastating neurological disease.”                                   

About NDC-1308
NDC-1308 is a novel chemical entity designed to address one of the root causes of MS, and is being developed for potential use either alone or in combination with other MS therapeutics that slow the progression of the disease. By controlling key genes in pathways leading to myelin synthesis, NDC-1308 appears to induce restoration of the lost myelin sheath that is believed to cause the devastating symptoms of MS. NDC-1308 is a small molecule that readily crosses the blood-brain barrier, allowing it to reach the tissues in the brain and spinal cord where promoting myelin production is needed. ENDECE Neural discovered NDC-1308, and owns the intellectual property surrounding the compound.

About ENDECE Neural
ENDECE Neural is a private biotechnology company at the forefront of developing therapies to repair and potentially reverse damage caused by devastating neurological diseases such as MS. A wholly owned subsidiary of ENDECE LLC, ENDECE Neural was founded in 2011 to focus on the development of what could be the first drug capable of inducing remyelination of damaged nerves in patients with MS. The company is leveraging decades of accumulated knowledge about how activation of estrogen receptors in a specific manner affects gene regulation. Researchers at ENDECE Neural have identified small-molecule compounds that upregulate key genes in pathways involved in promoting myelin sheath synthesis. ENDECE Neural is developing NDC-1308, which appears to directly induce OPCs to differentiate into mature oligodendrocytes that restore the depleted myelin sheath in rodent models of MS.  ENDECE Neural discovered and owns the intellectual property surrounding its compounds, and the company’s management team has a track record of successfully taking products from the laboratory through FDA approval and commercial release.

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