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Archive for the tag “research studies”

Study Shows MS Progresses Faster in Those Who Continue to Smoke

Summary
A new study involving people with MS who smoked cigarettes suggests that those who continued to smoke after receiving an MS diagnosis were quicker to reach the secondary-progressive phase of MS than those who quit after diagnosis.
Those who continued to smoke converted to secondary-progressive MS at a median age of 48, while those who quit smoking within the year after MS diagnosis progressed at a median age of 56.
This adds to evidence that smoking may speed progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression.
The team (Ryan Ramanujam, PhD, Jan Hillert, MD, PhD, and colleagues at Karolinska University Hospital Solna, Stockholm, Sweden) has published results in JAMA Neurology (Published online September 8, 2015). The full paper is available free of charge.

Background: In most people, MS begins with a relapsing-remitting course with defined attacks of worsening neurologic function, followed by periods of partial or complete recovery. Most people eventually transition to secondary-progressive MS, where the disease begins to progress or worsen more steadily, with or without relapses. The factors that determine if or when a person may transition to secondary-progressive MS are not fully understood. Some studies have found that smoking is related to disease progression, and that MS disability progresses more quickly in smokers, but the impact of quitting after diagnosis had not been thoroughly determined.

The Study: Investigators identified 728 people with MS who smoked at the time of MS diagnosis and were enrolled in the large Genes and Environment in MS Study in Sweden. Of these, 332 were classified as “continuers” who smoked at least one cigarette per day continuously from the year after diagnosis and 118 were considered “quitters,” who had stopped smoking within the year after diagnosis. A group of 278 were “intermittent smokers” but were not included in the final evaluation.

The main focus of the study was to determine how smoking was related to conversion to secondary-progressive MS, which occurred in 216 people. The researchers found that each year of smoking after diagnosis accelerated the time to conversion to secondary-progressive MS by 4.7%. Continuers progressed to secondary-progressive MS faster (at a median age of 48) compared with quitters (age 56).

Results were published in JAMA Neurology (Published online September 08, 2015). The full paper is available free of charge.

Comment: This is an important study that adds to evidence that smoking speeds progression of MS, and offers new evidence that quitting smoking after MS diagnosis may slow progression. In an accompanying editorial, Drs. Myla D. Goldman (University of Virginia, Charlottesville) and Olaf Stüve (University of Texas Southwestern Medical Center at Dallas) comment that this may be the first evidence that quitting smoking can delay conversion to secondary-progressive MS. “Therefore, even after MS diagnosis, smoking is a risk factor worth modifying,” they write.

The National Institutes of Health provides resources to help quit smoking: visit smokefree.gov or call 1-800-QUITNOW (1-800-784-8669).

An FDA Approved Generic Form of Copaxone® (Glatiramer Acetate) For Relapsing MS Called Glatopa™ Is Launched In the U.S.

A generic equivalent of daily Copaxone® (glatiramer acetate, 20 mg), called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) that was approved by the U.S. Food and Drug Administration in April, has been launched in the U.S. Glatopa is a disease-modifying therapy for people with relapsing forms of MS, including those who have experienced a first clinical episode and have MRI features consistent with MS.

The generic medication is a 20mg dose injected under the skin every day. This approval means that the manufacturer provided evidence that this generic medication is equivalent to the brand-name drug (Copaxone®).

According to Novartis which owns Sandoz, Glatopa would have a wholesale list price of about $63,000 per year. This is an estimated 15- 18 percent less than the list price of daily Copaxone. Sandoz advises that it will offer support services that include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for non-clinical questions, services not typically offered for generic medications.

“Having a generic option for one of the MS disease-modifying therapies is an important milestone, and it has the potential to increase access to MS therapies,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “As more generic and biosimilar options become available, we are hopeful that we will start to see some price relief for people living with MS” he added.

“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.” The FDA’s press release provides additional details (available here) related to how the agency determined the generic’s equivalency.

Selecting a therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

About Glatopa: The FDA has approved a generic medication that has been shown to be equivalent to 20mg daily glatiramer acetate. Glatopa is not a generic version of the 40mg dose of Copaxone taken every three days. Glatiramer acetate is a synthetic protein that mimics myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. The approved generic form of glatiramer acetate is given by subcutaneous (under the skin) injections every day.

Potential benefits: In clinical trials of glatiramer acetate, it was shown to significantly reduce annual relapse rates and new brain lesions as shown on magnetic resonance imaging (MRI), when compared to those who were given a placebo. This therapy has had a long track record of effectiveness and safety.

As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations. Clinical trials are generally not required to prove equivalence to a brand-name medication.

Potential risks and side effects: Side effects of glatiramer acetate that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome include injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor; unusual tiredness or weakness; and weight gain. There is also the potential for local damage to the skin (necrosis) and underlying tissue (lipoatrophy).

Some people using glatiramer acetate experience, at one time or another, a very temporary reaction immediately after injecting glatiramer acetate. This reaction, which often occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.

Unusual side effects of glatiramer acetate that should be discussed as soon as possible with your doctor include hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.

The National MS Society will provide more information about generic glatiramer acetate as it becomes available.

Download prescribing information (.pdf)
Read a press release from the FDA
Read more about disease-modifying therapies and other treatments for MS and MS symptoms.

Frequently Asked Questions: Approval of Generic Glatiramer Acetate

When will generic glatiramer acetate be available for prescription?

  • There is no information yet about when this medication, called Glatopa, will be available for prescription in the United States.

What will the generic glatiramer acetate cost?

  • Though we don’t have specific costs of Glatopa at this time, according to Novartis which owns Sandoz, the product would have a wholesale list price of about $63,000 per year.

What does it mean for a therapy to go generic – will Copaxone still be available for prescription?

  • As patent protections expire for Copaxone, other manufacturers are free to replicate it and seek drug regulatory agency approval to market it.
  • For many medications available as generics, the brand-name medications remain on the market. From the information currently available, it is expected that Copaxone will continue to be available by prescription in both the 20mg once daily dose, and the 40mg dose taken every three days.

What about insurance coverage for the generic or for Copaxone – will I be forced to switch from my current medication?

  • Coverage of prescriptions differs among various insurers. At this point we don’t know how insurers will handle coverage of Copaxone versus generic glatiramer acetate.

Does this generic medication 20mg dose have the same therapeutic benefit as 20 mg Copaxone?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will patient support services be available to people who are prescribed Glatopa?

  • According to Sandoz, it will offer support services that include financial assistance to qualified patients, personalized injection training, and 24-hour access to nurses for non-clinical questions.

Frequently Asked Questions: Generic Therapies for the Treatment of MS

The MS therapy landscape is continuously evolving. Two decades ago there were no disease-modifying therapies available, and now there are more than a dozen. We have also reached the point where “generic” versions of MS therapies are entering the marketplace. The following provides information about generic drugs and what they may mean for the MS community.

What is a generic medication?

  • A generic medication is a product that is equivalent to a brand-name drug whose patent protections have expired.
  • As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.
  • Generic makers are required to show that the generic drug delivers the same amount of active ingredients to the person’s bloodstream in the same amount of time as the brand-name product (referred to as “bioequivalency”).

What is the Society’s view of generic therapies for MS?

  • The National MS Society advocates for increased treatment options for people with all forms of MS. Early and ongoing treatment is currently the best known way to reduce future disease activity.
  • Having approved generics has the potential to increase individuals’ access to MS therapies and provides the MS community with more options.

Does the National MS Society recommend the use of this new generic MS therapy?

  • The National MS Society does not make individual treatment recommendations, but as we do for all other approved therapies, we make information available to constituents so that they can make informed decisions about their treatment choices.

Do generic medications have the same therapeutic benefit as name-brand medications?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will there be equivalent medications for all MS therapies?

  • It’s possible that eventually there will be. But before any medication may be copied, the patents protecting the brand-name medication must expire. Then a maker of equivalent medications would need to apply to the FDA with a request for approval of its medication.
  • The term “generic” technically applies to products that are considered drugs made through a chemical manufacturing process. Some of the MS therapies are classified as chemical drugs, and so when their patents expire, they would likely be eligible to be manufactured as generics. These FDA-approved therapies are classified as chemical drugs: Aubagio, Copaxone, Gilenya and Tecfidera.
  • The other MS therapies — Avonex, Betaseron, Extavia, Lemtrada, Plegridy, Rebif, and Tysabri — are technically classified as “biologics.” Biologics are generally more complex and they are made from human or animal materials rather than chemical processes. The technical term for equivalent medications for biologics is “biosimilar” or “follow-on biologic.”
  • The FDA has long-established requirements for the approval of generic medications, and has recently released guidelines related to the approval of biosimilars.

What is the current progress toward developing equivalent medications for MS therapies?

  • The FDA just approved a generic form of glatiramer acetate, and the agency has received Abbreviated New Drug Applications for other generic forms of this medication.
  • With the exception of Novantrone and Copaxone, no other disease-modifying MS medications are available in a generic form.

Where can I get more information about generic drugs and biosimilars?

The FDA’s Website has information about generic drugs and biosimilars and processes for their approval.

Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD.
Glatopa is a trademark of Novartis AG

Study Uncovers Gene Variation Linked to Response to MS Therapy; May Open Up New Treatment Approaches

Collaborating researchers in the U.S. and Italy have uncovered a gene variant that appears to influence whether a person responds well to interferon beta, a commonly used therapy for relapsing forms of MS. More broadly, the gene may regulate immune activity in unexpected ways, and its discovery may lead to new approaches to stopping inflammation and immune attacks in MS. Drs. Federica Esposito and Filippo Martinelli Boneschi (San Raffaele Scientific Institute, Milan), Philip L. De Jager (Brigham and Women’s Hospital, Boston) and colleagues have published their results in the Annals of Neurology (Early online May 14, 2015). The study was supported by the National MS Society and several other agencies.

Background: For reasons that are unclear, some people with relapsing forms of MS do not respond well to therapy and continue to experience disease activity despite being on a disease-modifying therapy. Previous genetic studies in MS have uncovered over 159 genetic variations that contribute to making people susceptible to developing MS, but these studies haven’t identified genetic variations that influence how a person responds to treatment. Finding a way to identify early in the disease course the best therapy for an individual – a “personalized medicine” approach – is likely to improve outcomes of treatment and quality of life for people living with MS. One of the lead authors of this study, Dr. De Jager, recently won the Barancik Prize for Innovation in MS Research for tackling critical questions like this with the goal of developing personalized treatments and prevention of MS.

This Study: Trying a different approach to search for genetic influences on treatment responses, the investigators first studied a group of individuals with MS who were taking interferon beta or glatiramer acetate. The individuals were classified as being responders, partial responders, or non-responders to their medication based on specific criteria. Then the researchers analyzed their full complement of genes (genome-wide association study) and found one genetic variant that was consistently associated with lack of response to interferon beta. When the researchers repeated this in three other groups of people with MS from Italy, France and the U.S., this finding held up.

The genetic variant (rs9828519) is near a gene (SLC9A9) that controls pH levels (acidity) within cells. The team explored functions of this gene, and found that its activity was diminished in people more likely to have MS relapses. They also conducted laboratory work, finding suggestions that the gene appears to play a role in regulating immune cell activity, and that its loss leads to damaging immune reactions. This suggests the gene may play a broader role in regulating immune activity.

Comment: Although the results of this study are not yet ready for applying to the management of MS, this discovery may lead to new approaches for stopping inflammation and immune attacks in MS. In addition, this study is an important step toward the goal of personalized medicine. The researchers point out that additional research is warranted to confirm their findings and to determine whether the genetic variant is relevant to how well people respond to other MS medications.

New molecule may lead to inflammation inhibitor

Scientists have developed a new drug-like molecule that can inhibit inflammation. The find has shown promise in preventing the progression of multiple sclerosis.
Walter and Eliza Hall Institute scientists have developed a small drug-like molecule called WEHI-345 that binds to and inhibits a key immune signaling protein called RIPK2. This prevents the release of inflammatory cytokines. Examining WEHI-345’s potential to treat immune diseases in experimental models of MS, it was found that WEHI-345 prevented further progression of the disease in 50 percent of cases after symptoms of MS first appeared.
Results of mouse model studies sometimes do not translate to humans and may be years away from being a marketable treatment. Calling the results extremely important, researchers said WEHI-345 had potential as an anti-inflammatory agent.
The study’s lead author, Dr Ueli Nachbur, said institute scientists would use WEHI-345 to further investigate the signaling pathway that produced inflammatory cytokines and to develop a better, stronger inhibitor of RIPK2 for treating inflammatory disease. “This signaling pathway must be finely balanced, because WEHI-345 only delayed signaling rather than blocked it. Nevertheless, this delay is enough to completely shut off cytokine production,” he said.
The research was published in the journal Nature Communications.

Study: Genetic variant may be MS risk factor

In a new study, researchers testing DNA in siblings with MS discovered a genetic variant in women that may increase risk of developing multiple sclerosis. According to study authors, the variant may be the one of the strongest genetic risk factors for MS discovered to date.

Researchers at the University of Illinois at Chicago were able to test three sisters among a group of five siblings between the ages of 23 and 26, all diagnosed with MS. What they found was a genetic change known as a single nucleotide polymorphism, or SNP – a change in a single base-pair of the DNA – in a gene called STK11, which plays a role in tumor suppression and is believed to have several roles in brain function. They found the variant in all three they tested.

To determine if the SNP could be a contributing factor to the siblings’ multiple sclerosis, the researchers screened DNA samples from 1,400 people – 750 with MS and 650 without – provided by Jorge Oksenberg at the University of California, San Francisco, who is a leading expert on the genetics of MS. They found that the SNP was 1.7 times as prevalent in women with MS as in women without the disease, making it one of the highest known genetic risk factors for MS.

Based on their analysis, the researchers estimate that the STK11 SNP is present in about 7 percent of the general population. But because far fewer people develop MS, other genetic or nongenetic factors must play a role in the development of the disease, said senior author Doug Feinstein, professor of anesthesiology at UIC and research biologist at the Jesse Brown VA Medical Center.

The variant occurs almost twice as often among women with MS as in women without the disease, making it “one of the strongest genetic risk factors for MS discovered to date,” said Feinstein.

The findings were published in the journal ASN Neuro.

How Common Is It To Have MS With Other Medical Conditions? First Results from the MS “Comorbidities” Project

Unfair as it seems, MS doesn’t keep other disorders away. It’s possible to have MS and “something else” at the same time. A new international initiative is being launched to understand how common it is for people with MS to have other conditions and how these other conditions may impact the course and treatment of an individual’s MS. The first stage of this project is now published, in preparation for an international scientific workshop jointly supported by the National MS Society and the European Committee for Treatment and Research in MS (ECTRIMS) to focus attention on comorbidities and determining next steps to finding solutions for people with MS.
Background: In scientific terms, having two chronic medical conditions at once is called “comorbidity.” There is growing recognition that comorbidities may complicate the diagnosis of MS and also influence disease progression, as well as an individual’s wellness and quality of life. In addition MS some other disorders may have risk factors in common. For these reasons, the MS Comorbidities Project is seeking to characterize the types and frequencies of comorbidities in MS in advance of a scientific meeting to map out next steps for research strategies to address this gap area. This project is being undertaken by the International Advisory Committee on Clinical Trials in MS, a committee comprised of international leaders in MS research and clinical care that is jointly supported by the National MS Society and ECTRIMS.
The first phase of this project was a systematic review of existing published studies related to specific medical conditions in people who have MS. Ruth Ann Marrie, MD, PhD (University of Manitoba) and colleagues* in Denmark, Italy and the U.S., now report their findings in seven papers published in the MS Journal. (Read overview and companion papers; no subscription is needed.) The review was supported in part by the National MS Society (U.S.A.) and a Don Paty Career Development Award from the MS Society of Canada.
Review Results: The authors identified more than 7,000 studies on a variety of comorbidities and MS, and narrowed these down, completing a full-text review of 249 studies that were conducted between 1905 and 2012. Most were conducted in North America or Europe, leading the authors to comment that little is known about comorbidities that occur with MS in Central or South America, Asia, or Africa. In addition, the quality and design of the studies were so variable that it was difficult to compare results. Nevertheless, their extensive research yielded these highlights, among many others:
• The five most prevalent disorders occurring alongside MS were depression, anxiety, high blood pressure, high cholesterol, and chronic lung disease.
• The most prevalent autoimmune diseases occurring with MS were thyroid disease and psoriasis.
• The types of cancer that occurred most often in people with MS were cervical, breast, and digestive system cancers. There appeared to be a higher than expected risk of meningiomas and urinary system cancers, and a lower than expected risk of pancreatic, ovarian, prostate and testicular cancer, compared to the general population.
• Some disorders were found more often than expected by the investigators based on previous research, such as heart disease, congestive heart failure, stroke, arthritis, inflammatory bowel disease, irritable bowel syndrome, seizure disorders, bipolar disorder, sleep disorders, and alcohol abuse.
Comment: The authors suggest that further work is necessary to develop data sources that examine MS comorbidities worldwide, and that are specific to individuals of different ages, genders, and ethnicities. They also conclude that efforts should be coordinated so that methodologies are similar and results can be compared.
To this end, the Society and ECTRIMS are convening a workshop that will move this research forward. The International Advisory Committee on Clinical Trials in MS and other experts in MS research will meet in spring 2015 to discuss next research steps, such as available data that may facilitate further research and which comorbidities demand more immediate focus.

Interim Results Reported from Clinical Trial of Stem Cell Transplantation in People with Relapsing-Remitting MS

A nationwide team of researchers report on interim results from a small, five-year study of transplantation of the individuals’ own hematopoietic (blood cell-producing) stem cells combined with high-dose immunotherapy in 24 people with relapsing-remitting MS. This procedure aims at “rebooting” the immune system to prevent MS immune attacks against the brain and spinal cord. At three years, 78.4% of participants experienced no new disease activity. When this trial has completed its five-year duration, it will be an important addition to research needed to determine whether this approach to stem cell transplantation is safe and effective in people with MS. Richard A. Nash, MD (Colorado Blood Center Institute) and colleagues report in JAMA Neurology (Published online December 29, 2014). This study was sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Background: One type of procedure that has been explored for many years in MS is called “autologous hematopoietic (blood cell-producing) stem cell transplantation” – or HSCT. This procedure has been used in attempts to “reboot” the immune system, which launches attacks on the brain and spinal cord in people with MS.
In HSCT, these stem cells (derived from a person’s own bone marrow or blood) are stored, and the rest of the individual’s immune cells are depleted usually by chemotherapy. Then the stored stem cells are reintroduced back to the individual’s bloodstream. The new stem cells migrate to the bone marrow and over time produce new cells. Eventually they repopulate the body with immune cells. The goal of this currently experimental procedure is that the new immune cells will no longer attack myelin or other brain tissue, providing the person, what is hoped to be, a completely new immune system.
The Study: Investigators enrolled 25 people who had experienced an MS relapse involving loss of neurologic function while taking disease-modifying therapies during the previous 18 months. Participants received HSCT along with high-dose immunosuppressive therapy (a regimen of treatments that profoundly suppress the immune system), and followed for five years. The primary endpoint of this study is whether participants experience “event-free survival,” meaning that they did not die or have an increase in disease activity. Disease activity is defined as any one of the following outcomes occurring: confirmed loss of neurologic function, clinical relapse, or new lesions observed on MRI scans. The current publication presents a planned analysis after three years of follow up.
Results: One individual experienced a pulmonary embolism induced by heparin (administered as part of stem cell collection), and withdrew from the study. Event-free survival at three years was 78.4%, down from 95.8% after one year. Treatment failed in five individuals. Scores on clinical scales measuring disease activity and quality of life, including the EDSS, improved significantly at three years after HSCT. Immune system analysis showed prolonged depletion of the immune cells that drive the immune attack, indicating that the immune system was indeed “rebooted.”
Two deaths occurred, one from complications due to MS progression and another due to asthma. One person experienced an MS attack, an individual who had not complied with a prednisone regimen designed to reduce this risk during collection of stem cells. There were 130 adverse events that were severe or life-threatening, mostly cytopenias (blood cell reductions) and infections.
Comment: Rigorous clinical trials of stem cell therapies are crucial to determining their safety and effectiveness in people with MS. “We look forward to seeing the completed results of this important study,” says Bruce Bebo, PhD, Executive Vice President of Research at the National MS Society. “There are significant risks involved in hematopoietic stem cell transplantation, and it’s important to ensure that this will be a safe solution for people with MS, with significant clinical benefit.”
With the urgent need for more effective treatments for MS, particularly for those with more progressive forms of the disease, the National MS Society believes that the potential of all types of cell therapies must be explored. The Society is currently supporting 15 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin, and has supported 70 stem cell studies over the past 10 years.

National MS Society Invests Nearly $19 Million in New Research to Stop Multiple Sclerosis, Restore Function and End MS Forever

What do exercise, skin cells and gut bacteria have in common? They are among the new leads being explored to move us closer to a world free of MS.

The National Multiple Sclerosis Society has committed nearly $19 million to support an expected 54 new MS research projects. These are part of a comprehensive research strategy aimed at stopping MS, restoring function that has been lost, and ending the disease forever – for every single person with MS.

This financial commitment is the latest in the Society’s relentless research efforts to move us closer to a world free of MS, investing more than $50 million in 2014 alone to support 380 new and ongoing studies around the world. So that no opportunity is wasted, the Society pursues all promising paths, while focusing on three priority areas: progressive MS, nervous system repair, and wellness and lifestyle.

Just a few of the new cutting-edge research projects include a study at Stanford University using skin cells to produce repair cells for possible future use to restore nerve-insulating myelin in MS; pre-clinical studies by a commercial firm (Glialogix) to test the nervous system-protective qualities of an oral therapy repurposed to address progressive MS; a Mayo Clinic study of beneficial gut bacteria for clues to a novel therapeutic strategy for MS; and a wellness study at the University of Illinois at Urbana-Champaign testing whether an exercise program done at home can increase strength and balance and reduce falls in people with MS.

“The comprehensive nature of these new research investments is very exciting,” noted National MS Society Executive Vice President, Research Bruce Bebo, PhD.  “While we’re driving research to stop MS, restore function and end the disease forever, at the same time we’re identifying key interventions and solutions that can help people with MS live their best lives now.”  Download details about the new research awards.

Multiple sclerosis interrupts the flow of information within the brain and between the brain and the body.  Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease.  Worldwide, over 2.3 million people live with the unpredictable challenges of multiple sclerosis.

“MS research is a top National MS Society priority, with increasing annual investments to drive solutions for every person with MS,” Cynthia Zagieboylo, President and CEO of the Society. “We fund the entire research spectrum, propelling novel ideas into the lab, translating breakthroughs into clinical trials, and moving success in clinical trials into new treatments for people living with MS.”

To find the best research with the most promise, the National MS Society relies on more than 130 world-class scientists who volunteer their time to carefully evaluate hundreds of proposals every year.  This rigorous evaluation process assures that Society funds fuel research that delivers results in the shortest time possible.

There are FDA-approved therapies that can impact the underlying disease course in people with the more common forms of MS.  However, none of these can stop progression or reverse the damage to restore function.  National MS Society-funded research paved the way for existing therapies – none of which existed 20 years ago – and continues to be a driving force of MS research.

Live Webcast: Research Advances from the World’s Largest MS Meeting

September 13, 2014

On Saturday, September 13, 2014, join a panel of experts for a live nationwide Webcast on “Research Advances from the World’s Largest MS Meeting

Saturday, September 13, 2014
2 – 3 pm ET (1 – 2 pm CT, Noon – 1 pm MT, 11am – Noon PT)

To register for the live webcast please click here.

Topics include:

  • Progressive MS
  • Genetics
  • Wellness and rehabilitation
  • Repair and protection

Moderator: Kate Milliken, founder, Milligrace Productions. Kate has been living with MS since 2006.

Panelists include:

Dr. Philip DeJager, Brigham and Women’s Hospital, Boston, MA

Dr. Don Mahad, University of Edinburgh, UK

Dr. Ellen Mowry, Johns Hopkins University, Baltimore, MD

Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer for the National MS Society

Register

We want to thank Genzyme, a Sanofi Company; Novartis Pharmaceuticals; Questcor Pharmaceuticals; and Walgreens Specialty Pharmacy for providing generous educational grants to make this program possible.

*For people who cannot participate in real-time, we will post the recorded version with transcript for viewing shortly after the event.

Results Published from First Human Clinical Trials of “Anti-LINGO” Myelin Repair Strategy

August 27, 2014

Results from two phase I human safety trials of an exploratory treatment aimed at repairing myelin damaged by multiple sclerosis have now been published. One to two treatments with Biogen Idec’s BIIB033 (anti-LINGO monoclonal antibody) were given by injection under the skin or into the vein of healthy volunteers and people with relapsing-remitting or secondary-progressive MS. No serious adverse safety events were reported, and although these studies were not designed to evaluate effectiveness, the results were considered positive and have led to a phase II trial, now underway in relapsing MS. The results were published on August 27, 2014 in the online journal Neurology® Neuroimmunology & Neuroinflammation.

“It’s encouraging to see an entirely new treatment strategy aimed at repairing MS myelin damage moving forward in clinical trials,” noted Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “Repairing myelin may be the best way to protect the nervous system from MS damage, and it holds potential for restoring function that has been lost in people living with this disease,” he added.

Background: In MS, immune attacks lead to the loss of myelin that coats and protects nerve fibers in the brain and spinal cord. Repairing the nervous system was just a dream a few years ago. Today it holds significant promise as a strategy to restore the function that MS has taken from people; and reducing or stopping MS progression. This remarkable progress is due in large part to the National MS Society’s comprehensive efforts and multi-million dollar research investments. Today the Society is supporting 87 research projects in nervous system repair, with multi-year commitments totaling over $35 million.

The first human trials of anti-LINGO leverage research aimed at stimulating the body’s natural healing abilities. LINGO is a protein seen in neurons and myelin-producing cells (oligodendrocytes), and blockading this protein with a monoclonal antibody called anti-LINGO has been shown to promote remyelination in animal models.

Details: In these first tests of anti-LINGO in humans, 72 healthy people and 47 people with relapsing-remitting MS or secondary-progressive MS were given anti-LINGO or inactive placebo by injection under the skin or into the vein. The participants with MS were given two treatments, two weeks apart.

All participants were monitored extensively for any signs of adverse reactions. There were no serious adverse safety events noted. The most common side effects included headache, upper respiratory tract infection, stuffy nose, GI symptoms and urinary tract infection, and these were experienced by participants who were on placebo as well as those who received doses of anti-LINGO.

Generally phase I studies are not designed to detect benefit, but largely to evaluate the safety and tolerability of exploratory therapies, to refine appropriate dosing, and to determine whether they reach their targets – in this case, the central nervous system. That is true of these trials, and there was no evidence from MRI or other tests that showed clear evidence that existing brain lesions healed from this short exposure to anti-LINGO. However, the safety, dosing and pharmacology results were considered positive and have led to the design and launch of a phase II trial by Biogen Idec, now underway in relapsing MS.

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