ECTRIMS

Need to Know: What Are ACTRIMS and ECTRIMS?

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by a frequent reference made in our forums as well as in our columns and articles.

Need to Know: High-dose Biotin Protocol

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topic “Have you tried the high dose biotin protocol?“, from…

#MSParis2017 – Genentech to Share Host of New Ocrevus Data at ECTRIMS-ACTRIMS Meeting

Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28. The presentations will offer new insights into the therapy's mechanisms, safety and effectiveness in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities. MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease. The information Genentech plans to present will demonstrate "the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,” Dr. Sandra Horning, the company's chief medical officer and head of its Global Product Development arm, said in a press release. Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy's favorable benefit-risk profile, Genentech added. Two presentations will cover new ways that doctors can look for signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another is tracking slowly evolving lesions. Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials, whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients' disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients' disease. Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus' ability to treat primary progressive MS. It will   look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevus’ safety —  based on open-label extension studies — will be another component of the presentations. So far, researchers have detected no new safety issues. Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company's scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute — as opposed to chronic — disease activity. In addition to "two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,” Horning said. One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits. The research team believes the FLOODLIGHT method may be be able to detect subtle changes better. This could make it a better predictor of disease activity and long-term patient outcomes. In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS. The U.S. Food and Drug Administration approved Ocrevus in March 2017.  

#MSParis2017 – Gilenya Reduces Relapses in Children and Adolescents with MS, Novartis Trial Shows

Gilenya decreased relapses in children and adolescents with multiple sclerosis in the phase 3 PARADIGMS trial, according to the therapy's developer, Novartis. The Swiss company will present the trial's results at the 7th Joint ECTRIMS-ACTRIMS meeting, set for Oct. 25-28 in Paris. The study addressed the safety and efficacy of an oral, once-daily dose of Gilenya in 215 MS patients aged 10 to 17. Participants received 0.5 mg or 0.25 mg of Gilenya, according to their body weight, and results were compared with those of intramuscular Avonex (interferon beta-1a given once weekly). The trial — conducted at 87 sites in 25 countries — was designed in partnership with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Pediatric Multiple Sclerosis Study Group. Gilenya led to a "clinically meaningful decrease in the number of relapses" over a period of up to two years, compared to Avonex, according to the trial. The safety results of Gilenya matched those observed in previous trials, with adverse events more likely among the Avonex group. Importantly, the PARADIGMS trial is the first-ever randomized, controlled Phase 3 study of a disease-modifying therapy in pediatric MS. No treatment is currently available for children and adolescents with MS. Novartis will now complete a thorough evaluation of the results and later submit Gilenya for approval by regulatory agencies. It will also extend the study to a five-year period.

#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.

Thinking, Hands, and MS!

ECTRIMS 2016 (European Committee for Treatment and Research in MS) produced lots of stories with exciting headlines about advances in MS research — and hopefully you read many of them here at MS News Today. As I went through the various presentation titles, there were a couple that jumped…

#Ocrelizumab – How Ocrelizumab Works

Ocrelizumab, an anti-CD20 monoclonal antibody, targets mature B-cells. Almost 95% of the B-cell population has these antigenic epitopes after maturation and does not shed them, which is what makes it a potent marker for therapeutic purposes (cancer being a very common area of interest in this regard). Read more…

Discovering a New World in MS Through Genomics, ECTRIMS 2015

A Satellite Symposia entitled “Discovering a new world in MS” supported by Teva Neuroscience was held yesterday, October 8, at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), currently taking place in Barcelona, Spain, October 7 – 10, 2015. Prof. David Brassat…

MS Care: A Hot Topic at #ECTRIMS2015

Three “Hot Topic Sessions” on multiple sclerosis will take place this afternoon (17:00 – 17:45 h, GMT + 1h) at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), currently being held in Barcelona, Spain, October 7 – 10. The first session is entitled…

Biomarkers and Predictors For Developing Future Personalized MS Therapies Discussed at ECTRIMS 2015

New developments in the diagnosis and treatment of multiple sclerosis (MS) are being discussed at this year’s 31st annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The symposium, being held in Barcelona, Spain, will foster discussions about development of individualized therapies for MS patients through a more targeted and efficient…

Biogen to Present Update on TECFIDERA (Dimethyl Fumarate) for Early Stage Relapsing-Remitting Multiple Sclerosis at ECTRIMS 2015

Biogen is scheduled to present the latest efficacy and safety profile updates on TECFIDERA (dimethyl fumarate), its lead treatment for relapsing-remitting multiple sclerosis (RRMS), during the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) happening now in Barcelona, Spain until October 10, 2015. The…