Patricia Silva, PhD, director of science content —

Patrícia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. Patrícia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles.

Articles by Patricia Silva

Fat Intake Increases Risk of Children with MS Having a Relapse, Study Suggests

Diet can play an important role in whether children with relapsing multiple sclerosis have a relapse, researchers at the University of California, San Francisco argue. Their study demonstrated that a diet with a lot of fat increases the risk of a youngster having a relapse by 56 percent, with saturated fat tripling the risk. Eating a lot of vegetables, on the other hand, cuts the risk in half, the team said. Since children with MS tend to have relapses more often than adults, the researchers figured they would be a suitable group to study diet's impact on relapse. They recruited 219 children with relapsing-remitting MS or clinically isolated syndrome from 11 centers across the U.S. Clinically isolated syndrome is a condition that can evolve in MS. The research team use a questionnaire known as the Block Kids Food Screener to analyze what the youngsters ate. They tracked the children an average of almost two years, which was plenty of time for relapses to occur. And, in fact, they did occur in 42.5 percent of the group. It turned out that fat had a particularly devastating effect on the youngsters' relapse rate. For every 10 percent increase in energy intake that came from fat, there was a 56 percent increase in the children's risk of having a relapse. Saturated fats were the biggest driver of risk. When researchers look only at these fats, they discovered that the risk more than tripled. Examples of saturated fats include processed meats such as sausages, ham, and burgers, butter, hard cheeses, and whole milk. Vegetables had the opposite effect on risk, the researchers observed. Using a cup equivalent as a standardized measure, they learned that for every additional cup of vegetables the children ate, the risk of a relapse dropped in half. To exclude the possibility that other factors influenced the results, the team included information about age, sex, ethnicity, duration of disease, body mass index, treatment, and D-vitamin levels in their analyses. This did not influence the results. The team also looked at whether other food components, such as sugar, iron, fruit and fiber, would affect the risk of relapse. They did not find any links. Although the risk associations were strong, the researchers cautioned that the study's observational design meant that it was not able to prove that fat causes relapses. But there are several ways that fat could play a role in disease processes, they argued. For instance, high fat intake triggers the release of inflammation-promoting molecules. It also affectsf gut bacteria that are linked to immune processes. Vegetables lower the risk of inflammation and immune problems, the team said. In an accompanying editorial, Dr. Kathryn Fitzgerald of the Johns Hopkins School of Medicine said the study had important limitations. Researchers gathered information on the children's diet only in the week before they enrolled in the study. This might not adequately capture more long-term dietary patterns, she said. And fat is not simply fat, she pointed out, arguing that fish oil is believed to help MS patients. Although the California research offers insight, she called for long-term studies to define diet's role in MS.

Among MS Patients, ‘Invisible’ Disability Leads to Poor Self-perceived Health, NYU Study Finds

Pain, walking problems and fatigue are factors that most strongly lower self-perceived health in multiple sclerosis (MS), researchers at the New York University Langone Medical Center have found. This challenges current treatment approaches focus mainly on physical disability. It suggests that “invisible disability” may be more important to how patients…

Researchers Identify Quality Control Regulatory Cells That Prevent the Production of Autoantibodies

The discovery of an immune cell quality control mission may have put scientists a step closer to understanding how autoimmune conditions such as multiple sclerosis arise. University of Alabama at Birmingham researchers identified regulatory immune cells with the quality control mission of destroying antibody-producing B-cells that mistakenly target the body's own tissue after an infection. An autoimmune disease is one in which the immune system attacks healthy tissue or organs instead of invaders. Eventually, the insight could lead researchers to new approaches for treating MS and other conditions caused by aberrant immune reactions. The Alabama researchers were studying the processes involved in the body's defense against a real threat — the influenza virus — when they discovered a population of immune cells whose action is relevant to autoimmune diseases. The study noted that T follicular regulatory cells appeared in the late stages of influenza infection. Their objective was to prevent the immune system from generating self-reactive antibodies — that is, those that attack the body's own tissue. These cells are poorly understood, the researchers explained. Their experiments, published in the journal Nature Immunology, focused on the molecular events surrounding the cells’ actions.  The team discovered that about a week after the infection, levels of an immune regulator called the IL-2 protein increased. This triggered the multiplication of common regulatory T-cells, or Tregs. When this phase of the immune reaction was fading, TFR cells started multiplying, reaching peak numbers about a month after infection. The formation of the TFR cells was therefore tightly linked to the processes controlling Treg production, researchers said, with falling levels of IL-2 allowing the new phase of the immune response. The TFR cells migrated to the lymph nodes — the headquarters of antibody-producing B-cells. Here, B-cells proliferate and change their antibody-producing genes to create new, stronger antibodies. But sometimes the gene changes, or mutations, give rise to an antibody that attacks the body, instead of invaders. Researchers discovered that TFR cells prevented B-cells, which gave rise to autoantibodies, from accumulating in the lymph nodes. Importantly, the TFR cells had no impact on the immune processes targeting the influenza virus. When researchers prevented TFR cells from forming or removed them from mice, the animals started producing autoantibodies, they explained. While this suggested that people with autoimmune diseases may have flawed TFR processes, the study did not investigate this, making the topic a possibility for future studies.

Lemtrada Prevented Progression of Multiple Sclerosis for Five Years, Study Shows

Two short courses of Lemtrada prevented multiple sclerosis from becoming active and progressing for five years, a study reported. Lemtrada's maker, Sanofi-Genzyme, said the study covered the two-year CARE-MS II Phase 3 clinical trial (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS. In addition to demonstrating Lemtrada's effectiveness, the study showed that it was safe, researchers said. The Phase 3 trial participants had had an active disease, with at least two relapses in the two years before the study and an inadequate response to earlier treatment. The trial compared Lemtrada's effectiveness with that of Rebif. The Lemtrada group received 12-mg doses for five consecutive days at the start of the study and three consecutive days a year later. Ninety-three percent of the 435 patients who completed the trial enrolled in the extension, which followed patients for another three years. Remarkably, 60 percent of patients required no additional treatment after the two years of the Phase 3 study. Among the 376 patients who required more treatment, 30 percent had one additional Lemtrada course, 10.4 percent had two, and 1.6 percent had three. A small proportion of patients also received other disease-modifying treatments. The most common reason for additional treatment was relapse. Nevertheless, Lemtrada reduced annualized relapse rates to only 0.18 of patients by the fifth year. In addition, during the five years, 75 percent of patients experienced no worsening of their disability over six-month cycles. And 49 percent of patients' disability improved. Researchers also tracked patients' scores on the NEDA — or No Evidence of Disease Activity — index. The composite measure takes into account relapses, disease activity detected in MRI scans, and disability progression. In year five, 58 percent of patients achieved NEDA, slightly more than the 53 percent in year three. Another important finding was that patients' loss of brain tissue slowed in the first two years, and dropped further during the extension. Researchers also noted that adverse events dropped during the extension trial. Ninety-six percent were mild or moderate, and no patient left the study because of side effects. The rate of infusion-associated reactions was lower in the extension study than in the Phase 3 study. Patients who did have a reaction most often experienced headache, fever, or rash. Infections did not become more common with accumulating Lemtrada doses and, again, were less common in the extension trial. Patients most often developed colds or urinary tract infections. Autoimmune reactions against the thyroid gland were relatively common, however. Thirty-eight percent of patients developed them over the five years. Most were moderate in severity. Four patients developed various types of cancers. Researchers also examined Lemtrada in the CARE-MS I clinical trial and its extension trial. They reported long-term outcomes and safety findings similar to those in the latest study. Overall, the newest results demonstrated that Lemtrada slowed disease progression over five years in relapsing-remitting MS patients who failed to respond to previous therapy.

Can iPhone App Grasp the MS Experience? Duke Study Wants to Find Out

Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].

Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…

Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'd in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.

Woman with MS and Spouse to Trek 500 Miles to Raise Awareness, Funds for MS Society

April and Bernie Hester are busy planning their second 500-mile thru-hike of South Carolina's Palmetto Trail, which they will begin on Oct. 1 to raise awareness for multiple sclerosis and funds for the National MS Society. Thousands of people hike parts of the trail every year, but few do the entire 500-mile hike, said Suzette Anderson, of the Palmetto Conservation Foundation (PCF), an organization dedicated to conserving South Carolina's natural and cultural resources. The couple's "Finish MS Hike" is the second time they'll be hiking the full trail this year. In April they started hiking from the sea and 66 days later completed the trail in the mountains. This time they'll start in the mountains and end at the sea. The couple will traverse over mountains, on trails, through cities, and on roadways. April, who has MS, is hoping that her efforts will bring much-needed awareness to the condition and that the pair can reach their goal of raising $100,000 for MS research toward a cure. Their effort, combined with the debilitating effects of MS, are among the reasons why April and Bernie Hester were recognized as trail ambassadors by the PCF. The couple will post regular updates on their “Finish MS Hike” blog and Instagram account, to allow people to follow their adventures, read about their journey, and gain insight as they face and conquer challenges along the way. The couple has already written a few entries to keep their audience informed. The Palmetto is the longest trail and largest trail construction project in South Carolina. Today, the trail crosses the state from Walhalla in the mountains of Oconee County to Awendaw on the coast in Charleston County. Another 150 miles in the Midlands and Upstate remain to be acquired and constructed. To help raise money to "Finish the Trail," the PCF and RJ Rockers Brewing Company have combined their passions for trekking and craft beer to create Palmetto Trail Pale Ale. A portion of sales goes to support and finish the Palmetto Trail. You can buy Palmetto Trail Pale Ale at any of the following locations: RJ Rockers Brewery, Craft and Draft, Texas Roadhouse, Thirsty Fellow, Flying Saucer, Capital City Club, Triangle Char+Bar, Bohemian Bull, Publico Kitchen & Tap.

Goal Attainment Interventions May Reduce Cognitive Fatigue in MS, Study Finds

Behavioral therapy focusing on goal attainment might reduce cognitive fatigue in multiple sclerosis patients, finds a study that used brain imaging to examine goal-oriented tasks involving rewards. Since fatigue is one of the most common MS symptoms, affecting up to 90 percent of patients, researchers at the Kessler Foundation in East Hanover, New Jersey, say their findings could open the door to new non-medication approaches to treating MS-related fatigue. Scientists believe that a part of the brain, called the fronto-striatal network, causes fatigue. But studies also show that the network is active during goal attainment tasks, and that such tasks can reduce fatigue in healthy people. Equipped with this knowledge, Kessler researchers recruited 19 MS patients and 14 healthy controls, and exposed them to one of two conditions. In the first, they had the chance to win money while gambling. Researchers called this the outcome condition. The second condition did not include the prospect of a reward, or outcome. The tasks were performed in a brain scanner. Using functional magnetic resonance imaging of the brain — a method that tracks brain activity by monitoring blood flow — researchers could study how different tasks activated the fronto-striatal network. It turned out that the prospect of a reward activated parts of the network in deep brain structures, while parts of the prefrontal cortex were more active during the task without a potential reward. Importantly, the activation seen during the reward condition was linked to significantly lower levels of fatigue, which researchers measured outside the scanner. While researchers used a gambling task to study the process, similar exercises like achieving a good score on a test, might work equally well, researchers said. In fact, goal attainment is already incorporated in many neuropsychological rehabilitation efforts, including in MS.

National MS Society Among Groups Promoting Sept. 22 as Falls Prevention Awareness Day

Today is Falls Prevention Awareness Day, an annual campaign that occurs every Sept. 22 to encourage multiple sclerosis patients and others prone to falls to give a little extra thought on how to identify factors for falls. The event, coordinated by the National Council on Aging, will be the 10th in an annual series that has taken place since 2007. The National Multiple Sclerosis Society is contributing to the event by presenting research into MS-related falls, as well as resources to identify risk factors of falling. Research shows that 50 to 70 percent of MS patients report falling at least once over a six-month period, with about 30 percent falling several times. Many people with MS also get injured when they fall, adding significantly to the burden of MS. Studies show that typical MS symptoms, such as poor gait and balance, or the loss of proprioception — the perception of where body parts are in a space — contribute to falls in MS, which typically occur while doing everyday activities at home. To better understand why people with MS fall, and how to best prevent it, current research focuses on better detection of falls. One approach is to use automatic fall detection devices, which patients can wear. A 2015 symposium on gait and balance in MS focused specifically on falls. The meeting concluded that although knowledge and prevention strategies have improved, much remains to be done. In that regard, the International MS Fall Prevention Research Network helps researchers collaborate on falls research. But neurological symptoms are not the only factors at play. Psychological issues make up another area in the risk spectrum, says the NMSS. Fear of falling or overconfidence both contribute, as does inactivity. Besides the guide, the NMSS has also developed the Free From Falls program, containing eight modules with webinars, downloadable educational material and video-guided exercises. These materials teach patients about biological, behavioral and environmental risk factors for falling, while also offering tips and strategies that may reduce the risk of falls.

Winner of $4.9 Million Research Award Tests Online and Teleconference-based Methods to Reduce MS-related Fatigue

People with multiple sclerosis (MS) often face geographic barriers that end up limiting their treatment options. That has led a Case Western Reserve University researcher to test online- and teleconference-based methods of reducing fatigue and improving patients’ quality of life. Matthew Plow, assistant professor at the university’s Frances Payne Bolton…

Cognitive Impairment Worse Among PPMS Than RRMS Patients, German Study Finds

Patients with primary progressive multiple sclerosis have more severe cognitive impairment than those with relapsing-remitting multiple sclerosis, according to a German study that analyzed published data on the topic. PPMS patients did especially poorly on verbal learning and verbal memory tests, said the study, which suggested that PPMS patients need disease management that specifically focuses on their cognitive difficulties, which do not necessarily correlate with the degree of overall disability. The study gathered data from 47 previously published studies in an attempt to analyze potential differences in cognitive performance between patients with RRMS and PPMS. These studies included 4,460 patients — 3,456 with RRMS and 1,004 with PPMS — and plenty of information about patient and disease features. This allowed researchers to perform a meta-analysis of pooled data from various studies, that is considered the highest level of scientific evidence. Researchers noted that PPMS patients performed worse on cognitive tests, both when considering global scores and tests of specific cognitive domains. Yet both groups scored similarly in levels of anxiety, depression and fatigue. Using statistical analyses, the research team found that differences in sex, education, disease duration, manual dexterity and fatigue could not explain the poorer test results among PPMS patients. On the other hand, PPMS patients were, on average, older than those with relapsing disease, and the team found that this difference accounted for poorer test results in cognitive tests of processing speed and working memory. Yet differences in other cognitive aspects also remained when researchers took age into account. Differences in disability, measured by the Expanded Disability Status Scale, could also not explain why PPMS patients performed worse on the cognitive tests. A detailed look revealed that the largest differences between RRMS and PPMS patients were in verbal learning and verbal memory, along with the age-associated difference in processing speed. Depression and anxiety also brought down processing speed, researchers said, even though the two groups did not differ in their levels of anxiety and depression. The data shows that cognitive impairment in MS is not directly related to the course of the disease. Research may explain differences in other factors including genetics, the degree of brain tissue loss and medications.

Swedish Study Suggests Stem Cell Transplants as Possible Treatment for Aggressive RRMS

Autologous hematopoietic stem cell transplants for relapsing-remitting multiple sclerosis (RRMS) are superior to currently approved disease-modifying drugs, according to a Swedish study published in the Journal of Neurology, Neurosurgery & Psychiatry. In addition, says the review, the procedure’s safety profile has improved in the last decade, and is now just…

MS Humorist Yvonne DeSousa, in GeneFo Webinar, Offers Tips on How Laughter Can Make You Feel Better

Laughter really is among the best medicines when it comes to multiple sclerosis, says Yvonne deSousa, an MS patient, humorist and author who plans to share her tips on integrating humor into daily living, in a free webinar organized by GeneFo. The webinar, which will also discuss research into laughter therapy for MS, will take place Sept. 13 at 1 pm EST (6 pm in the United Kingdom). Scientists are increasingly aware that emotions play a crucial role in determine progression rates and outcomes of chronic diseases. This has led researchers to study how therapies including humor and laughter might contribute to improve patient's well-being. DeSousa, a native of Cape Cod, Massachusetts, has been nominated for a WEGO Health Hilarious Patient Leader Award. She promises to offer hands-on advice on how to “find the funny, de-stress, and enjoy a good laugh” despite the reality of living with a chronic and debilitating condition such as MS. The online lecture will also focus on the biology of how laughter can improve patient outcomes. Research shows that laughing affects immune and endocrinological processes, while increasing tolerance to pain. Laughter also counteracts anxiety and depression. These factors, deSousa pointed out, are all crucial in MS, and she should know. The comic has taken a humorous approach to her own illness from the start, and now runs a blog that recently made the Top 50 MS Blog list. She's also written a book — called MS Madness — on the topic. The webinar will also introduce a research project led by Dr. Theodore Brown that now seeks MS patients for a study of how laughter therapy affects mood, stress and self-efficacy. Researchers hope these types of studies will encourage doctors to incorporate humor-based practices into common care protocols for MS. Details of the research program will be shared with webinar attendees. Those wishing to participate in the free webinar — and receive a video recording by email later — can register by following this link.

Merck Extension Study Confirms Mavenclad’s Long-term Benefits in Relapsing MS Patients

Three-fourths of relapsing multiple sclerosis patients who took two short courses of Mavenclad over two years remained relapse-free for four years, according to newly published data from the medication's Phase 3 extension trial. Moreover, patients who took Mavenclad during the first two years and then a placebo for the next two years fared similarly to those who took Mavenclad for the entire four-year period. The European Commission on Aug. 25 approved Mavenclad — developed by Merck KGaA (known as EMD in North America) — to treat relapsing forms of MS in Europe. It based that approval on data from the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS trials, as well as the Phase 2 ONWARD trial, and the ongoing long-term PREMIERE study. Besides showing the long-term impact of two short courses of Mavenclad — patients took tablets for a maximum of 20 days over two years — this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merck’s earlier studies, which suggested that Mavenclad resets the immune system. This is a stark contrast in treatment approach to most approved MS drugs which work by suppressing either T- or B- immune cells over the long term. Researchers also deemed safety to be similar in the two groups. Most adverse events were mild or moderate, and most patients who had their B-cells and T-cells depleted in the first part of the study had normal, or nearly normal, levels at the end of the extension. Shingles were most common in patients who received the highest cumulative dose of the drug, affecting 4.8 percent of participants. But in the remaining treatment groups, rates of the viral infection were similar at 1.1 to 2 percent, researchers said. Besides Merck's own studies, an independent study recently demonstrated that Mavenclad also improves patients’ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

#MSParis2017 – TG Therapeutics to Discuss Ublituximab’s Effectiveness at ECTRIMS–ACTRIMS Meeting in Paris

TG Therapeutics will discuss ublituximab's ability to deplete B-cells linked to multiple sclerosis and to reduce inflammatory brain lesions at the 7th Joint ECTRIMS–ACTRIMS Meeting in Paris next month. The three presentations will cover preliminary results of a Phase 2 clinical trial of ublituximab's safety and effectiveness as a treatment for relapsing forms of MS, the company said in a press release. The conference will be Oct. 25-28. Dr. Amy E. Lovett-Racke of Ohio State University will discuss ublituximab's ability to decrease B-cells associated with MS after six months of treatment. Ublituximab is an antibody that targets B-cells carrying the CD20 protein on their cell surfaces. These cells are thought to play a role in MS development. Dr. Matilde Inglese of the Icahn School of Medicine at Mount Sinai in New York will discuss ublituximab's ability to decrease study participants' inflammatory brain lesions. And Dr. Edward Fox of Central Texas Neurology Consultants, the trial's principal investigator, will do a poster-session presentation on the study's patient characteristics and preliminary results as a whole, including safety. The ongoing Phase 2 trial is still recruiting patients with relapsing forms of MS. Researchers are randomly assigning participants to receive intravenous infusions of either ublituximab or a placebo. One of the study’s primary goals is to see how well ublituximab depletes B-cells 28 days after the start of treatment. Another primary goal is to see how safe the therapy is, with the measurement being treatment-related adverse events that patients experience over six months. Ublituximab’s ability to reduce relapses will be a secondary measure of the trial. Researchers will assess it after 48 weeks of treatment. Fox, who is the director of the Multiple Sclerosis Clinic of Central Texas, and a clinical assistant professor at the University of Texas Medical Branch in Round Rock, made a ublituximab presentation at the 3rd Congress of the European Academy of Neurology in June. It revealed that the therapy nearly depleted B-cells only four weeks after treatment started. Earlier data suggests that ublituximab can be administered in only one hour. Ocrevus, the only approved MS therapy that targets B-cells with CD20, requires 3 1/2 hours. Although the Phase 2 trial is continuing, the data generated so far supports plans for two Phase 3 trials, TG Therapeutics said. They will randomize patients to receive either ublituximab or Aubagio. The trials, which the company hopes to start by the end of September, will be conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. It allows the FDA to evaluate the design and population size of a trial a company intends to use to seek a drug's regulatory approval. The FDA has refused to approve therapies whose trial design it believed to be flawed. Obtaining a design sign-off before a trial improves the chance of a treatment being approved if it meets the study's objectives.

Retroviral RRMS Treatment GNbAC1 Fails Phase 2 Trial, But Research Continues, Say Sponsors

A Phase 2b trial assessing the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and Servier — the two European companies that jointly developed the drug…