June 21, 2019 News by Joana Carvalho, PhD Cyxone Launches Phase 1 Trial Assessing T20K for MS CyxoneĀ launched the first-in-human Phase 1 clinical trial assessing the effects of T20K, its new therapeutic candidate for the treatment of multiple sclerosis (MS), in healthy volunteers. The announcement came after the company received approval from the Dutch Ethics Committee and Central Commission on Research Involving Human…
June 13, 2019 News by Alice MelĆ£o, MSc DELIVER-MS Trial Recruiting RRMS Patients to Help Improve Treatment Decision-making A clinical trial based at the Cleveland Clinic and the University of Nottingham, U.K., is recruiting patients with relapsing-remitting multiple sclerosis (RRMS) to compare two treatment strategies, the National Multiple Sclerosis Society announced. The Phase 4 study, called DELIVER-MS (NCT03535298), intends to enroll about 800…
May 31, 2019 News by Ana Pena PhD Cyxone Nears First-in-human Trial for Investigational Preventive MS Treatment T20K CyxoneĀ submitted an application to the Netherlands research ethics committee to start the first clinical trial in humans testing T20K, its investigational preventive treatment for multiple sclerosis (MS). Approval by the Netherlands regulating authority…
May 28, 2019 News by Joana Carvalho, PhD IPMSSG Issues Guidelines on Participation of MS Youngsters in Clinical Trials The International Pediatric Multiple Sclerosis Study Group (IPMSSG) has updated its guidelines regarding the participation of children and adolescents with multiple sclerosis (MS) in clinical trials. The new series of guidelines were published recently inĀ Neurology, the journal of theĀ American Academy of NeurologyĀ (AAN), in an article titled…
May 24, 2019 News by Vijaya Iyer, PhD First Patient Dosed in Phase 2B Trial Testing SAR442168 Therapeutic Candidate for RRMS The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma,Ā in collaboration withĀ Sanofi Genzyme, for MS and other central nervous…
May 24, 2019 News by Ana Pena PhD MC10, AbbVie Plan Clinical Trials to Explore Using BioStamp nPoint Device for MS Patients MC10 and AbbVieĀ are working together to launch clinical trials exploring the use of BioStamp nPoint, a system of wearable sensors that collects health data fromĀ multiple sclerosis (MS) patients, to determine if the information may serve as meaningful measures for clinical studies. MC10’s BioStamp…
May 22, 2019 News by Joana Carvalho, PhD Simvastatin, Common Statin, Treats SPMS in Ways Distinct from Cholesterol, Study Suggests Simvastatin, a widely prescribed statin that works to lower cholesterolĀ levels, may slow brain atrophy and disease progression in people with secondary progressive multiple sclerosis (SPMS) for reasons unrelated to changes in blood cholesterol, a new analysis of a Phase 2 clinical trial reports. These findings are in…
April 16, 2019 News by Jose Marques Lopes, PhD Trial Testing Deprexis Online Therapy for MS-related Depression Enrolling in US, Germany A clinical trial testing a computer program called Deprexis as a home-based therapeutic strategy for multiple sclerosis (MS)-related depression is enrolling participants with allĀ types of MSĀ at three sites in the U.S. and two in Germany. The U.S. study locations are the Cedars-Sinai Medical Center,…
March 15, 2019 News by Jonathan Grinstein Cleveland Clinic Nevada Joins DELIVER-MS Trial Assessing RRMS Treatments The Cleveland ClinicĀ Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from theĀ DELIVER-MS trial, titled āDetermining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosisā (…
March 13, 2019 News by Santiago Gisler Phase 2 Trial Will Assess Autologous Mesenchymal Stem Cell Therapy to Treat Progressive Forms of MS The National Multiple Sclerosis SocietyĀ 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…
March 11, 2019 News by Alberto Molano, PhD Immunic Therapeutics Enrolls First Patient in Phase 2 Trial of IMU-838 for RRMS Immunic TherapeuticsĀ has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy forĀ relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…
March 5, 2019 News by Patricia Inacio, PhD #ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial Full results of a Phase 2 clinical trial testing TG Therapeuticsā lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…
February 26, 2019 News by Santiago Gisler Cleveland Clinic Chosen for Phase 2 Trial Testing NurOwn Stem Cell Therapy in Progressive MS Patients BrainStorm Cell Therapeutics announced theĀ Cleveland ClinicĀ is the first clinical site contracted in the United States for the Phase 2 multi-center study evaluating the companyās NurOwn mesenchymal stem cell (MSC) therapy in individuals with progressive multiple sclerosis (MS). āWe are very excited to announce The Mellen Center for…
January 31, 2019 Columns by Tamara Sellman 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 topicĀ “Have you tried the high dose biotin protocol?“, from…
January 31, 2019 News by Alice MelĆ£o, MSc MS Patients Sought to Test Alternative Chronic Pain Treatment Methods A clinical trial funded by the National Multiple Sclerosis Society is recruiting adult patients with multiple sclerosis (MS) to test two non-pharmacological strategies to manage MS-related chronic pain. The trial (NCT03782246) will be conducted at the University of Washington, and plans to enroll about 250 participants across…
January 25, 2019 News by Jonathan Grinstein Positive Safety Data Reported for High-dose MS Treatment Candidate Temelimab GeNeuroĀ has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses ofĀ GNbAC1, developed for the treatment of neurological and autoimmune disorders, includingĀ multiple sclerosis (MS). The company also announced that the World Health…
January 7, 2019 News by Alice MelĆ£o, MSc More Effort Needed to Recruit Minorities to Phase 3 Clinical Trials, MS Expert Says Because multiple sclerosis (MS) presentation and progression course can be very different between people of African ancestry and Caucasians, the recruitment of minorities to Phase 3 clinical trials is of particular importance. Researchers in the MS field and the general MS community should make a greater effort to improve…
December 21, 2018 News by Patricia Inacio, PhD Stem Cell Transplant Lessens Disability and Relapses in RRMS Patients, Phase 2 Trial Shows Treatment withĀ autologous hematopoietic stem cell transplantĀ (aHSCT) led to a sustained decrease in disability and almost no clinical relapses in patients withĀ relapsing-remitting multiple sclerosisĀ (RRMS)Ā who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows. Trial findings were published in the study, āProspective phase…
December 19, 2018 News by Ana Pena PhD Ampyra Significantly Improves Walking Ability As Reported by MS Patients, Phase 3 Trial Shows Treatment with Ampyra (dalfampridine) for 24 weeks leads to sustained and clinically meaningful improvements in walking ability as reported by multiple sclerosis (MS) patients with gait difficulties, according to a study analyzing results from a Phase 3 trial. The study, “Assessment of Clinically Meaningful Improvements in Self-Reported…
December 19, 2018 News by Alberto Molano, PhD FDA Gives Green Light to Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Patients The U.S. Food and Drug Administration (FDA) has approvedĀ BrainStorm Cell Therapeutics‘ request to open a Phase 2 clinical trial testing the safety and effectiveness of its proprietary NurOwn mesenchymal stem cell (MSC)Ā treatment inĀ progressive multiple sclerosis (MS) patients. The request was in the form of Investigational New Drug…
December 18, 2018 News by Alice MelĆ£o, MSc FDA Asked to Approve Diroximel Fumarate as Oral Treatment for Relapsing MS AlkermesĀ filed a request for the approval of diroximel fumarate (BIIB098) to treatĀ relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by BiogenĀ in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…
November 30, 2018 News by Alice MelĆ£o, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
November 21, 2018 News by Patricia Inacio, PhD Phase 1 Trial of ATA190 Cell Therapy Shows Promise in Treating Progressive MS Atara Biotherapeuticsā investigational ATA190, a cell therapy that wipes out immune B-cells infected with the Epstein-Barr virus (EBV), led to neurological improvements and reduced symptoms in patients with primary and secondary progressive multiple sclerosis (MS), a Phase 1 trial shows. The trial results were published in the Journal…
October 15, 2018 News by Alice MelĆ£o, MSc #ECTRIMS2018 ā Additional Analysis on Ozanimod Demonstrates Its Potential to Treat Relapsing MS Additional analysis of clinical data from Celgeneās investigational agent ozanimod continues to demonstrate its potential to benefit patients with relapsing multiple sclerosis (MS). Findings from the Phase 3 SUNBEAM and RADIANCE Part B trials were discussed at the 34th Congress of the European Committee for Treatment and…
October 15, 2018 News by BioNews Staff #ECTRIMS2018 – Post-hoc Analyses Support Safety and Efficacy of Mavenclad, Merck KGaA Says Substantial data supporting both the effectiveness and safety of Mavenclad (cladribine tablets) is before the U.S. Food and Drug Administration (FDA), and may lead to its approval as a short-course oral treatment for people with relapsing-remitting multiple sclerosis (RRMS) some seven years after a first such request…
October 12, 2018 Columns by Ed Tobias MS Patients Capture the Ear of a Pharma Company People with multiple sclerosis (MS) rarely get the opportunity to talk to the people who design their medications. But a new collaboration is providing that opportunity to a few of us. The Accelerated Cure Project for Multiple SclerosisĀ (ACP) and pharmaceutical manufacturer EMD Serono have begun working together…
October 12, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018: Study Proposes Serum Neurofilament Light Threshold to Identify RRMS Patients at Risk of Worsening Relapsing-remitting multiple sclerosis (RRMS) patients with serum neurofilament light chain (sNfL) levels higher than a proposed threshold have a higher risk of disease activity, and worsened disability, lesions and brain shrinkage in the long term, according to a new study. The research, āSerum neurofilament light (NfL)…
October 11, 2018 News by BioNews Staff #ECTRIMS2018 ā Data from 2 EU Trials Shows Effectiveness of Cannabidiol Spray in Treating Spasticity Data from two European trials ā a real-life study in Italy, and a long-term Czech trial looking at impact on cognition ā supported the efficacy of a widely approved cannabinoid spray in treating moderate to severe spasticity (muscular stiffness or involuntary spasms) in multiple sclerosis (MS) patients who…
October 10, 2018 News by Alice MelĆ£o, MSc FDA, EMA Agree to Review Novartis Therapy Siponimod to Treat SPMS Novartis is seeking U.S. and European approval of its investigational oral agent siponimodĀ to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…
October 9, 2018 News by Janet Stewart, MSc EMD Serono, ACP Work Jointly to Make MS Clinical Trials More Patient-focused The Accelerated Cure Project (ACP) for Multiple SclerosisĀ andĀ EMD Seronoā a unit of Merck KGaA ā Ā will jointly incorporate the perspectives of U.S. and CanadianĀ multiple sclerosis (MS) patients into the design and implementation of clinical trials. The ACP, a nonprofit group based in Waltham, Massachusetts, strives to accelerate…