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Results Announced from Phase 2 Clinical Trial of Ibudilast Suggest Reduction of Brain Atrophy (Shrinkage) in People with Progressive MS

SUMMARY

  • Top-line results were announced of a phase 2 clinical trial testing an oral anti-inflammatory therapy ibudilast (MN-166, MediciNova, Inc.) in people with progressive forms of MS.
  • The results announced in a press release concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS.
  • The trial was conducted at the Cleveland Clinic and 27 other sites across the U.S., and involved 255 people with primary or secondary progressive MS.
  • The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that supplied ibudilast. The National MS Society also provided funding support.
  • Further details are schedule to be presented Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.
  • These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies. Ibudilast was designated by the FDA as a “Fast Track Product” which could speed its future development as a possible treatment of progressive MS.

“These results sound like a very promising step toward a potential new therapy for people with progressive forms of MS, for whom there are few treatment options,” said Dr. Bruce Bebo, Executive Vice President, Research, National MS Society.

DETAILS
Background: Ibudilast (MN-166, MediciNova, Inc.) inhibits an enzyme called phosphodiesterase, resulting in suppression of inflammation. While considered a “New Molecular Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat cerebrovascular disorders and asthma. It is being also being investigated in the U.S. for its potential to treat ALS and drug addiction.

The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that will supply ibudilast. The National MS Society also provided funding support because of its focus on progressive MS and because the trial’s design may answer important questions about the best ways to measure the benefits of therapies aimed at protecting the nervous system from MS.

The study: The trial, known as “SPRINT-MS,” was led by Principal Investigator Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. It was conducted at the Cleveland Clinic and 27 other sites across the U.S. The trial involved 255 people with primary or secondary progressive MS. The primary outcome measure was change in brain atrophy (as measured by an MRI analysis technique called brain parenchymal fraction) after 96 weeks.  Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS. Other imaging, safety, clinical and quality of life outcomes were also measured.

The results announced in a press release from MediciNova concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Further details are schedule to be presented on Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.

What’s Next? These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies. Ibudilast was designated by the U.S. Food and Drug Administration as a “Fast Track Product” which could speed its future development as a possible treatment of progressive MS.

 

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Study Questions Influence of High-Salt Diet on MS

SUMMARY

  • Some recent studies have suggested that high intake of salt in the diet might influence MS disease activity and progression, but other studies have not confirmed that link.
  • In work partly funded by the National MS Society, researchers took advantage of data accumulated from a previous clinical trial involving 465 people with possible early signs of MS (CIS) whose salt levels in urine were measured over the course of 5 years.
  • They found no connection between salt intake and MS activity.
  • The study, “Sodium Intake and Multiple Sclerosis Activity and Progression in BENEFIT,” was published in the July 2017 issue of the Annals of Neurology (2017;82:20-29).
  • Although this study does not support a link between high-salt diets and MS disease activity, research suggests that most Americans eat more salt than is recommended by federal guidelines. Reducing dietary salt is considered by most to be beneficial to the heart and circulatory system.

DETAILS
Background: Several recent studies have suggested that dietary salt (sodium chloride) could potentially influence MS disease activity and progression. For example, one study of 70 people with relapsing-remitting MS, who were followed for two years, found that higher levels of salt measured in urine samples were associated with a higher rate of relapses and larger brain MRI lesions. In addition, mice fed a high-salt diet developed a more aggressive course of EAE, a laboratory model of MS. But two studies in pediatric MS did not find a relationship between self-reported salt intake and MS risk or relapse rates. Resolving this question is important because it offers the possibility that reducing salt intake might improve a person’s overall health and their course of MS.

This Study: In work partly funded by the National MS Society, researchers set out to determine if a high-salt diet is associated with faster conversion from a first neurologic episode (known as clinically isolated syndrome or CIS) to a diagnosis of definite multiple sclerosis, or with MS disease activity. Kathryn C. Fitzgerald, ScD (Johns Hopkins School of Medicine), Alberto Ascherio, MD, DrPH (Harvard T. H. Chan School of Public Health) and colleagues took advantage of data accumulated from a previous clinical trial involving 465 participants who participated in a trial called BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment) over 5 years. The trial compared benefits of giving interferon to individuals with CIS early versus later. Each person provided an average of 14 urine samples throughout the five-year follow-up. The researchers estimated average long-term sodium intake from the multiple urine samples, adjusting for age, sex, height, weight, where participants lived, and many other variables.

Results: Researchers found that neither average nor high urine sodium levels were associated with conversion to definite MS. They also weren’t associated with new MRI lesions at any point in the five years, relapse rates, or progression of disability. These results suggest that high sodium intake does not play a major role in influencing MS disease course or activity in people treated with interferon, at least in the early stages of the disease.

While the study has several strengths, including its length, large sample size, and systematic collection of data, it has limitations: BENEFIT participants were treated nearly uniformly with interferon, and the results may not apply to people on other therapies or no therapy. In addition, participants in the BENEFIT trial were primarily Caucasian and resided in Europe and Canada, and it isn’t known if similar results would apply to other populations and ethnicities. The results also don’t answer the question of whether salt intake affects the risk of developing MS in the first place.

The study, “Sodium Intake and Multiple Sclerosis Activity and Progression in BENEFIT,” was published in the July 2017 issue of the Annals of Neurology (2017;82:20-29).

Comment: Although this study does not support a link between high-salt intake and MS disease activity, research suggests that most Americans eat more salt than is recommended by federal guidelines. Even in the absence of direct evidence that MS immune activity is influenced by salt, reducing dietary salt is considered by most to be beneficial to the heart and circulatory system.

Read More: Diet, along with exercise, cognitive health, and other healthy behaviors can make a big difference to how you feel as you deal with MS. Learn more about living well with MS

Researchers Recruiting People with Primary Progressive MS for Genetics Studies – Key to finding treatment options

Primary progressive MS is characterized by steadily worsening neurologic function from the onset of the disease. There are still many gaps in the knowledge we have about what differentiates relapsing-remitting from primary progressive MS, and the underlying mechanisms of primary progressive MS. The MS Genetics Group at the University of California San Francisco is recruiting people with primary progressive MS for a research study involving a one-time blood sample donation with the goal of identifying genetic factors driving the course of the disease. The team also is looking for people without MS who are not related to serve as controls. The team hopes to identify the major genetic factors that play a role in disease presentation and progression. Please note: you do not have to be located in or travel to California to participate. Everything for the study can be done remotely and is free of charge to participants.

Rationale: Specific subtle variations in the human genome are known to play a role in determining who is susceptible to developing multiple sclerosis, and may also influence the course of the disease. People living with MS can make a difference in studies searching for these genes by donating their DNA with a blood sample. Identifying the exact location and role of MS genes could help determine who is at risk for developing the disease and can provide clues to its cause, prevention, and lead to better treatments.

Details: Once an individual has completed the initial online intake form, they will receive a call from the study coordinator to discuss details and answer any questions. The consent form and health information privacy form can be signed electronically. Participants will then be emailed a link to two additional short online surveys and sent a blood-collection kit. The kit includes everything necessary for the blood draw, which can be taken to your local Quest Diagnostics Lab and returned in a prepaid envelope to the lab at UCSF. There is no cost to participants.

Contact: To participate or request additional information, please complete a brief intake survey.
OR you may contact UCSF directly:
Clinical Research Coordinator
UCSF Multiple Sclerosis Genetic Susceptibility Project
675 Nelson Rising Lane, Suite 235A, Box 3206
San Francisco, CA 94158
Email: msdb@ucsf.edu
Toll Free Phone: 1-866-MS-Genes (1-866-674-3637) or Office Phone: (415) 502-7202

 

New Research on Lemtrada Reveals Insights into the Cause of Potential Side Effects

Researchers in the U.K. have evaluated additional findings about the immune-system impacts of Lemtrada® (alemtuzimab, Sanofi Genzyme), a disease-modifying therapy for treating people with relapsing MS.

The team used data from phase 3 clinical trials submitted to the European Medicines Agency during the drug’s successful approval process. Some of this data was previously reported at medical meetings and in Lemtrada’s prescribing information.

Among their findings, they report that Lemtrada caused long-term reduction of specific immune cells (memory B and T cells, including regulatory T cells). They also found that the body rapidly repopulated an overabundance of immature B cells.

They propose that the blockade of memory B and T cells drives the beneficial effects of Lemtrada.

They also speculate that the known potential side effect for autoimmune thyroid disease and other autoimmune disorders may be triggered by the overabundance of immature B cells that occurs when there are few regulatory T cells to keep them in check.

Studies like this one, which reveal more information about a therapy’s mode of action, are important and may also lead to insights about how to reduce side effects.

Drs. Klaus Schmierer, David Baker and others at the Queen Mary University of London report their findings in JAMA Neurology, published online June 12, 2017.

Read the open-access paper in JAMA Neurology
Read about Lemtrada
Read more about treating MS

Lemtrada is a registered trademark of Sanofi Genzyme

New MS Research

This month in Lancet Neurology, a Canadian research team reports there is a pre-clinical phase in MS. The study used health administration records from four Canadian provinces (British Columbia, Saskatchewan, Manitoba, and Nova Scotia). Due to the nature of the Canadian health-care system, these provinces have computerized health-care records on >99% of residents, including hospital discharges, physician billing, prescription on records, and dates of all medical visits – all records can be linked by a unique health-care number assigned to individuals. Using these records, medical histories for 14,428 MS cases and 72,059 controls were included for this study. They compared health-care utilization in the same five-year period prior MS diagnosis between cases and temporally matched controls.

Interestingly, five years before a MS diagnosis, the number of hospital admissions for people who eventually developed MS was 26% higher than controls, and this increased to 78% higher a year before MS diagnosis. A similar pattern was observed for physician billing (5 years before diagnosis: 24% higher in people with MS than controls; 1 year before diagnosis: 88% higher in people with MS than controls). There was also a substantial increase in the number of prescribed drug classes in people with MS compared to controls (5 years before diagnosis: 23% higher; 1 year before diagnosis: 49%  higher). These results clearly demonstrate a pre-clinical stage for MS where subtle symptoms exist before clinically definitive symptoms (also known as a prodromal stage). With further research, we can explore these subtle symptoms and hopefully diagnose MS earlier and initiate therapeutics earlier, slowing the rate of progression of MS.

From: When do MS symptoms start? By Farren Briggs PhD, ScM; The Accelerated Care Project for Multiple Sclerosis

Interesting Results…

Gene That Boosts Resistance to Malaria linked to Susceptibility to MS and Lupus in Sardinia

Researchers from Italy found a strong association between the gene that instructs the molecule “BAFF” and susceptibility to MS and lupus in studies of nearly 6,000 people in Sardinia. The BAFF gene is crucial to activation of immune B cells and is also associated with resistance to malaria. Malaria was common in Sardinia until it was eradicated in 1950. The rates of MS and certain immune-mediated diseases are high in Sardinia. Further research is necessary to confirm whether this high rate is related to BAFF, and whether MS could be treated by a therapy that targets BAFF.

Read more about this study from the Genetic Literacy Project

Read the scientific summary of the paper in The New England Journal of Medicine

Read more about efforts to end MS forever

 
 

Novel Protein Identified Inside Cells During MS Inflammation May Help Explain Nerve Damage

Researchers from the University of Alberta in Canada report that levels of Rab32 – a protein that directs traffic between cell organs – are increased in sites of active inflammation in brain tissue obtained from people with MS and in mouse models of MS-like disease. This increase was linked to the destruction of nerve cells. If the results are confirmed, this knowledge could explain part of the neurodegenerative process that leads to progression of disability in MS and could be a target for development of effective MS treatments.

Read more on ReliaWire
Read the open access paper in Journal of Neuroinflammation
Read more about Research to stop MS in its tracks

Researchers Recruiting African Americans with MS Across the U.S. for Genetics Studies – Key to finding cause of MS and better treatments

Rationale: Genes are known to play a role in determining who is susceptible to developing multiple sclerosis, and may also influence the course of the disease. People living with MS can make a difference in studies searching for these genes by donating their DNA from blood samples. Identifying the exact location of MS genes could help determine who is at risk for developing the disease and may provide clues to its cause, prevention, and better treatment. Focusing on ethnic groups with lower susceptibility to MS (such as African-Americans) and higher susceptibility (such as individuals of Northern European descent), and searching for what is common and what is different in their genes may help pinpoint regions that contain MS genes. Large numbers of participants are needed to accelerate this research.

Details: It is not necessary to travel to San Francisco to participate in this study. Once an individual has completed the initial online intake form and has agreed to participate, they are emailed the links to two additional online forms and sent a kit via express mail. The kit includes a consent form, a health information privacy form, and a medical records release form. The kit also includes everything necessary for the blood draw, which can be taken to your local Quest Diagnostics Lab, where the blood can be drawn and then returned in a prepaid envelope to the UCSF MS Genetics Lab. There is no cost to the study participants.

Contact: To participate or request additional information, please complete our brief intake survey.

OR you may contact us directly:

Clinical Research Coordinator
UCSF Multiple Sclerosis Genetic Susceptibility Project
675 Nelson Rising Lane, Suite 235A, Box 3206
San Francisco, CA 94158
Email: msdb@ucsf.edu
Website: http://msgenetics.ucsf.edu/index.html
Toll Free Phone: 1-866-MS-Genes (1-866-674-3637)

MRI Study Yields Clues to the Development of Primary-Progressive MS

Summary

  • In a study of 453 people described as having radiologically isolated syndrome (specific areas of damage on MRI scans with no accompanying symptoms), about 12% eventually developed primary-progressive MS. This mirrors the frequency of primary-progressive MS seen in other studies of people with MS.
  • Those who developed primary-progressive MS were more likely to be men, were significantly older, and were more likely to have MS-like lesions in the spinal cord compared to those who went on to develop clinically isolated syndrome (CIS) or relapsing-remitting MS.
  • This study provides a rare glimpse of a very early stage of disease even before progression begins, and provides additional evidence of the value of research into radiologically isolated syndrome. Finding a way to identify and track primary-progressive MS earlier may help to improve access to care for those who have it.
  • The team (Dr. Orhun Kantarci, Mayo Clinic and Foundation, and national and international collaborators) published their findings in Annals of Neurology (published online, December 29, 2015).

Background: Diagnosing MS can be challenging, and it often happens in stages. The term “clinically isolated syndrome” (CIS) is used to describe a first episode of neurologic symptoms  that lasts at least 24 hours and is caused by inflammation and demyelination in one or more sites in the brain and spinal cord. Individuals who experience a CIS may or may not go on to develop definite MS. However, clinical trials of specific disease-modifying therapies have led to approvals for their use to treat CIS.

Some people have specific, “clinically silent” lesions (areas of inflamed or damaged tissue) on MRI, meaning that they are experiencing no symptoms and only have imaging findings. There has been growing research on this phenomenon, called “radiologically isolated syndrome (RIS),” which like CIS may or may not go on to develop into definite MS. There is debate as to whether people with RIS would benefit from early treatment with disease-modifying therapies.

Primary-progressive multiple sclerosis is a relatively rare form of MS, with about 10% of all people with MS receiving this diagnosis. It is characterized by steady worsening of neurologic functioning, without any distinct relapses (also called attacks or exacerbations) or periods of remission.

The Study:  This team examined data from 453 people with RIS collected from 22 investigators in five countries; a database of 210 people with MS in Olmsted County, Minnesota; and a cohort of 754 people with progressive MS.

Of the 453 people with RIS, 128 (28%) went on to develop a first neurological event consistent with CIS or relapsing MS. Of these, 15 (11.7%) developed primary-progressive MS. Those who developed primary-progressive MS were more commonly men, and older at diagnosis by approximately 10 years, than the 113 people who developed CIS/MS. The frequency of primary-progressive MS and age comparisons were similar to those identified in other groups of MS. Of the 15 who went on to develop primary-progressive MS, 12 had MRI scans of the spinal cord, and all 12 had lesions in the spinal cord, compared with 64% of those who developed CIS/MS.

The team (Dr. Orhun Kantarci, Mayo Clinic and Foundation, and national and international collaborators) published their findings in Annals of Neurology (published online, December 29, 2015).

Conclusions: This study provides a rare glimpse of a very early stage of disease even before progression begins, and provides additional evidence of the value of research into radiologically isolated syndrome. Finding a way to identify and track primary-progressive MS earlier may help to improve access to care for those who have it.

Read more about primary-progressive MS

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