Author Archives: Santiago Gisler

EMD Serono, the biopharmaceutical division of Merck KGaA in the U.S. and Canada, announced the launch of the company's Multiple Sclerosis Leadership and Innovation Network (MS-LINK), an interdisciplinary research community aimed at improving the care of individuals with multiple sclerosis (MS).The program will combine clinical outcomes and real-world data with scientific and precision medicine to advance MS research and improve the daily lives of MS patients. Initial collaborators include the National MS Society and the University of Texas Southwestern Medical Center."Real progress in MS will not come from just one lab or one doctor, but from working together collaboratively with the brightest minds in MS to drive a true paradigm shift in how we treat and support people living with this disease," Rehan Verjee, president of EMD Serono and global head of the Innovative Medicine Franchises, said in a press release."Together with the National MS Society and the University of Texas Southwestern Medical Center, our work to bring together research focusing on patient-reported outcomes, real-world data and precision medicine has only just begun, and we're excited to continue to grow the MS-LINK network ... ," Verjee added.MS-LINK branches into two separate research networks. The first is clinically oriented and analyzes real-world data and patient-reported outcomes to better understand clinical factors affecting the daily lives of MS patients, and how to improve patient-centered care.Researchers will use magnetic resonance imaging-based 3D modeling and artificial intelligence to investigate the differences between MS-specific and non-specific brain lesions. The goal is to improve disease diagnosis and surveillance through the understanding of these differences.The 3D modeling approach also will serve to investigate ethnic-specific treatment responses by assessing changes in lesion size, shape, and surface features upon MS treatment."Being able to see and feel a 3D printed lesion in your hand is very different from looking at it on a screen, even if you're examining a 3D model," said Darin T. Okuda, MD, project lead investigator, and professor of neurology and neurotherapeutics at the University of Texas Southwestern Medical Center."This is an important advancement for patients and healthcare professionals, and also artificial intelligence researchers, as investigating accurate 3D representations of MS brain lesions both before and after treatment has unmatched explanatory power," Okuda added.The second research network, which is the scientific and precision medicine network, will provide resources and research that can aid physicians, including individualized medicine based on differences in genes, environment, and lifestyle.As part of the second network, EMD Serono also funds a pilot research program testing how aging affects MS. In partnership with the National MS Society, the program will collect preliminary data to determine the possibility of further funding.“Partnering with EMD Serono's MS-LINK initiative will enable us to fund more research focused on understanding how aging contributes to MS progression," said Bruce Bebo, PhD, executive vice president of research at the National MS Society."Pilot projects funded by this collaboration could help identify new innovative strategies for slowing down, stopping, or even reversing MS progression," Bebo added.MS-LINK will continue to seek collaboration partners and expand research areas, with new community members and studies planned for later this year. Among future topics, the community will focus on MS-related immune involvement, treatment selection, shared decision-making, and modifiable risk factors.

Pear Therapeutics, in collaboration with Novartis, has launched a study evaluating the clinical use of Pear-006, its software-based prescription digital therapeutics (PDT) product for treating depression symptoms in people with multiple sclerosis (MS). PDTs belong to a new class of treatment strategies in healthcare intended to treat diseases,…

Retrospective comparison between children with multiple sclerosis (MS) and those with related acute demyelinating syndromes (ADS) highlights the implications of fatigue, depression, and quality of life in these patients. Those are the findings from a study, “Fatigue, depression, and quality of life in children with multiple sclerosis: a…

High levels of satisfaction with the efficacy and convenience of Aubagio (teriflunomide), an oral treatment for relapsing multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found. The study “Teriflunomide real-world evidence: Global…

A collaboration between DNAnexus, the Sutter Health network, and the University Pittsburgh Medical Center (UPMC) aims to improve personalized medicine in multiple sclerosis (MS) through the first large-scale clinical genomic research study, the companies announced. The network has the goal of improving screening, diagnosis, and treatment of…

In recognition of Multiple Sclerosis Awareness Month, AscellaHealth, a national pharmacy benefit management company, is calling attention to its clinical and educational program designed to assist individuals with multiple sclerosis (MS). The program plan is intended to offer specialty pharmacy strategies to help manage costly and complex…

Schwann cells surrounding neurons protect the degeneration of nerves by blocking thrombin, a blood-clotting protein that can also damage nerves, according to a new study. These findings may aid in the further understanding of genetic and molecular mechanisms behind conditions such as multiple sclerosis (MS). Results of the study, “Glial cells…

The National Multiple Sclerosis Society is funding a new Phase 2 clinical trial to test the effectiveness of stem cell therapy on individuals with progressive forms of multiple sclerosis (MS), using mesenchymal stem cells from their own bone marrow. The ability of stem cells to both self-renew and create…

Axim Biotechnologies announced that it has succeeded in microencapsulating cannabinoids (chemical compounds in cannabis) into the company’s patented chewing gums, which are used to treat several disease symptoms, including pain and spasticity associated with multiple sclerosis (MS). Since the active cannabinoids are degradable in the body, the company needed…

BrainStorm Cell Therapeutics announced the Cleveland Clinic is the first clinical site contracted in the United States for the Phase 2 multi-center study evaluating the company’s NurOwn mesenchymal stem cell (MSC) therapy in individuals with progressive multiple sclerosis (MS). “We are very excited to announce The Mellen Center for…

A clinical trial to test the effects of antioxidant treatment with lipoic acid on progressive forms of multiple sclerosis (MS) is recruiting 118 participants at seven sites in North America. The study sites include: Birmingham, Alabama; Burlington, Vermont;  Portland, Oregon; Salt Lake City, Utah; Seattle, Washington; Washington, D.C., and;…

Multiple sclerosis patients who began treatment with Gilenya and stayed with it continuously showed a more than 50 percent reduction in annual relapse rates, a real-world study following these people for up to three years found. Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing-remitting multiple sclerosis , approved in 2010. It acts by binding and modulating receptors — called sphingosine-1-phosphate receptor — on lymphocytes (adaptive immune cells). By binding to these receptors, Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord, and so lower lymphocyte-induced inflammation and damage. Although several clinical trials have reported reduced annualized relapse rates (ARRs) upon treatment with Gilenya, few long-term real-life studies have examined the relapse rate reductions over a long term. A team, led by Novartis researchers and a scientist at Central Texas Neurology Consultants, collected MS patient data from the MarketScan database, a U.S. claims database including medical and pharmacy claims (bills submitted to health insurance providers), between 2009 and 2016. Among 9,312 MS patients in the database with at least one filled Gilenya prescription, 1,599 adults (mean age, 46) met the study's inclusion criteria, including having at least one inpatient or two outpatient claims, and a total of four years of continuous health plan enrollment. Among these 1,599 patients, all used Gilenya for one year (cohort 1), 1,158 (72.4%) took Gilenya continuously up to the start of year two (cohort 2), and 937 (58.6%) used the therapy up to the start of year three (cohort 3). Baseline analysis — measures taken at the study's start — showed that the most common MS-linked symptoms were disorders of the optic nerve and visual pathways (reported in 22-24%), followed by fatigue/malaise (20-21%). Hypertension (20-21%) and depression (15-16%) were the most common physical and mental comorbidities, respectively. The mean annualized relapse rates (AARs) at baseline in these three groups of patients — cohorts 1 to 3 — ranged between 0.48 and 0.51. A consistent reduction in ARRs was seen in all three groups: cohort 1 had a 0.25 ARR at the close of the first year, for a 51% reduction from the baseline rate; cohort 2 a 0.22 ARR at the start of year two, for a  54% lowering in relapse rates from baseline; and cohort 3 had 0.23 ARR at the third year, amounting to a 53% reduction. As expected, when researchers calculated ARRs among patients with continuous Gilenya use over these three years, they found a greater reduction in annual relapse rates. Mean ARRs in continuous-use patients were 0.19 (a 61% reduction) during the first year, 0.18 (a 62% reduction) during the second year, and 0.18 (a 61% reduction) at the start of the third year. “This retrospective claims database study found that patients with MS who received fingolimod [Gilenya] therapy experienced a durable and sustained reduction in relapse rates over a 3-year period,” the researchers wrote, with findings representing “a durable reduction in relapse rates by [more than] 50%.” Reasons that some patients discontinued treatment were not a focus of this study, they added.

Almost one in five patients diagnosed with multiple sclerosis (MS) and referred to one of two MS-specialized centers in the U.S. were found to not have the disease, a study at those two centers reported. Migraine was the most common correct diagnosis eventually given these people. The retrospective study…

Australian researchers from the University of Newcastle and the Hunter Medical Research Institute (HMRI) have received funding for two projects that will study unexplored areas in multiple sclerosis (MS). The projects, investigating the role of epigenetic differences in MS severity and treatment against MS-derived fatigue, received $211,000 AUD (about $151,300…

Biogen announced the start of a global Phase 3b clinical trial to evaluate the efficacy and safety of extended interval dosing (EID) with Tysabri (natalizumab) in patients with relapsing-remitting multiple sclerosis (RRMS). Results of the six-week dosing interval will be compared with the approved standard interval dosing…

Many multiple sclerosis (MS) patients report that cannabis has beneficial effects on their symptoms with minimal side effects, according to a survey that also showed that varying effects on health may be due to differences in how users consume cannabis. Findings from the survey were reported in the…

Researchers at the Ural Federal University (UrFU) in Russia have developed a neuro-electrostimulation system that has the potential to treat different types of brain disorders, including multiple sclerosis (MS). The system allows physicians to treat patients by remotely controlling the delivered electric pulse through a smartphone or tablet. Details…

Pendopharm’s Glatect (glatiramer acetate) — a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) — has been added to the public drug plan in the Canadian province of British Columbia, and is now the only glatiramer-based treatment for RRMS patients there using the plan. After Copaxone…

Changeable lifestyle factors influence the risk and severity of depression associated with multiple sclerosis (MS), a study based on a large group of patients shows. According to the study, alcohol consumption in particular was linked negatively with depression incidence and severity. In addition, a healthy diet and vitamin D and omega-3 supplementation…

Relapse rates in women with multiple sclerosis (MS) decline during pregnancy, as does the use of disease-modifying therapies, before both adjust to pre-pregnancy levels again, a large U.S. study based on real-world data shows. The study, “Relapses and disease-modifying drug treatment in pregnancy and live birth…