June 15, 2020 News by Joana Carvalho, PhD ERT Acquires APDM With Goal of Better Data for Movement Disorder Trials ERT, which specializes in clinical trial data collection, announced it has acquired APDM Wearable Technologies (APDM), a provider of wearables and digital biomarkers, to improve the accuracy of key efficacy measures used in clinical studies of multiple sclerosis (MS), Parkinsonās, and other movement disorders. A…
June 15, 2020 News by Marta Figueiredo, PhD Experts Clarify Concepts of MS States to Improve Patient Care, Clinical Trials An international committee of multiple sclerosis (MS) experts further clarified how guidelines, updated in 2013, should be used to classify this disease’s different states, and stressed the importance of measuring these states in a timely and consistent manner. The group’s statement, āThe 2013 clinical course descriptors…
June 11, 2020 Columns by Tamara Sellman Need to Know: What Participating in MS Research Entails Editor’s note: “Need to Knowā 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 post āIāve Been Spoiled by My Clinical Trial,ā published March 5. Share your…
May 11, 2020 News by Joana Carvalho, PhD MMJ Can Ship Cannabis Products to US for Clinical Testing, Agencies Say MMJ International HoldingsĀ announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment forĀ multiple sclerosis (MS) and Huntingtonās disease. The process was facilitated by the U.S. Drug Enforcement AgencyĀ (DEA), which worked alongside…
May 4, 2020 News by Marisa Wexler, MS Ublituximab Phase 2 Data Support Safety, Efficacy in Relapsing MS The investigational anti-CD20 antibody ublituximabĀ effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests. Findings further suggest that the…
April 20, 2020 News by Marisa Wexler, MS Sanofi to Detail Trial Results of Oral Relapsing MS Therapy Online on Thursday Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…
March 23, 2020 News by David Melamed, PhD Phase 2 Trial of Progressive MS Treatment Postponed Due to COVID-19 A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosisĀ has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…
March 13, 2020 News by Margarida Azevedo, MSc Second Phase 3 Trial of MedDay’s MD1003 for Progressive MS Fails to Meet Goals MedDay Pharmaceuticals‘Ā MD1003 did not ease functional disability or its progression in patients with non-active progressive multiple sclerosis, Phase 3 clinical trial data shows. The SPI2 Phase 3 study (NCT02936037) sought to confirm the positive results of a first Phase 3 trialĀ called MS-SPI…
March 6, 2020 Columns by Ed Tobias FDA Approval of Investigational DMT Ozanimod May Be Weeks Away By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide…
February 7, 2020 News by Marisa Wexler, MS Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint ā a significant reduction in the number of new lesions visible on a brain imaging scan ā in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…
February 6, 2020 Columns by Tamara Sellman Need to Know: What Is the Microbiome? Editor’s note: “Need to Knowā 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 “Newly Diagnosed MS Patients Show Changes in Gut Microbiome, Study Says,” from Dec. 3, 2019.
January 29, 2020 News by Marta Figueiredo, PhD New Imaging Agent of Myelin for Earlier MS Diagnosis, Myeliviz, Entering Clinical Testing TheĀ U.S. Food and Drug AdministrationĀ (FDA)Ā has agreed to allow Myeliviz, an imaging agent of myelin ā the protective layer that covers nerve fibers and isĀ damaged inĀ multiple sclerosisĀ (MS) ā to be evaluated in a clinical trial with healthy volunteers. Myeliviz, created byĀ Case Western Reserve UniversityĀ researchers, has the potential…
January 10, 2020 News by Catarina Silva Vitalis Plans to Launch Phase 3 Trial Testing VTS-72 as Treatment for RRMS-related Flushing Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing ā facial redness, itching or rash ā in patients with relapsing-remitting multiple sclerosisĀ (RRMS). Flushing is a common side effect of an oral MS therapy called…
January 9, 2020 News by Vanessa Pataia New Trial Compares Stem Cell Treatment to Available Therapies for Severe Relapsing MS A new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS). At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms…
December 20, 2019 News by Ana Pena PhD Future MS Trials Should Focus on Patient Experience, Providing Long-term Data, Working Group Says Trials testing new immunotherapies for multiple sclerosis (MS) should focus more on patients’ experiences and on symptoms relevant for them such as fatigue, depression, and cognitive difficulties, a German working group recommends. According to the team, which is working on developing new standards for planning MS trials, clinical…
December 2, 2019 News by Alice MelĆ£o, MSc Mount Sinai Taking Part in Phase 2 Trial of NurOwn Cell Therapy in Progressive MS Mount Sinai Medical Center has joined withĀ BrainStorm Cell Therapeutics to explore the safety and efficacy of NurOwn as a potential treatment for progressive multiple sclerosis (MS) in an ongoing Phase 2 trial. The New York center is the fourth clinical site participating in the trial, in addition…
November 27, 2019 News by Iqra Mumal, MSc MS Specialist to Lead Trial of Temelimab in Progressing Disease Without Relapses GeNeuro is collaborating with clinical researchers at theĀ Karolinska Institutet and the Academic Specialist Center (ASC) in Stockholm to open a new clinical trial of temelimab in people whoseĀ multiple sclerosis (MS) is progressing in the absence of relapses. Fredrik Piehl, MD, PhD, a professor of neurology at…
November 20, 2019 News by Alice MelĆ£o, MSc MMJ Enters Agreement to Produce Cannabis-based Capsules for Clinical Trials in MS and Huntingtonās MMJ International HoldingsĀ announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule ā a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) ā in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
October 31, 2019 News by Ana Pena PhD Medicinal Cannabinoids Not Effective for Mental Disorders, Small Relief on MS Anxiety, Analysis Suggests A joint analysis of 83 studies, involving 3,000 people, concluded that there is “scarce evidence” to say that the use of medicinal cannabinoids ā chemical compounds in the cannabis plant ā is able to improve mental health conditions. However, the use of pharmaceutical tetrahydrocannabinol (THC) may lead to…
September 25, 2019 News by Ana Pena PhD #ECTRIMS2019 – Should Vitamin D Supplements Be Recommended for MS? Yes, Researchers Say Editorās note: This is the second story in a three-part report examining experts’ answers to the question “Should vitamin D supplements be recommended for MS patients?”, which was a topic discussed at this year’sĀ Congress of the European Committee for Treatment and Research in Multiple SclerosisĀ (ECTRIMS).Ā Here, we take an in-depth…
September 23, 2019 News by Marisa Wexler, MS EMD Serono Opening Phase 3 Trials of Oral Evobrutinib in Relapsing MS Patients EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinibĀ in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Brutonās tyrosine kinase (BTK), which is…
September 18, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks ā more than 2 years ā according to data from an extension Phase 2 trial. The data were shown in a…
September 11, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Remyelinating Therapy Liothyronine Well-tolerated by MS Patients, Phase 1b Trial Finds Treatment with a potential remyelinating agent called liothyronine was safe and well-tolerated by people with multiple sclerosis (MS) in a Phase 1b trial. Preliminary results also suggested benefits in cognition, motor function, and fatigue. The study, āA Phase 1b, open-label study to evaluate the safety…
September 10, 2019 News by Joana Carvalho, PhD NervGen Planning Clinical Trials of NVG-291, Peptide That Might Promote Myelin Repair NervGen PharmaĀ announced plans to open clinical trials evaluating the potential of its lead candidate NVG-291 to treat multiple sclerosis (MS) and spinal cord injury. NVG-291 is an investigational peptide that has shown an ability to stimulate nerve regeneration following an injury in several animal models of disease.
September 4, 2019 Columns by Cathy Chester Ageism in Clinical Trials and Healthcare The idea, they say, is to keep having birthdays, and I agree. I see aging as a precious gift, and when you live with multiple sclerosis (MS), that gift is even more golden with each passing year. We earn every wrinkle, gain new…
August 14, 2019 News by Joana Carvalho, PhD US Agency Asked to OK Cannabinoid Shipments from Canada to Support Studies in MS, MMJ Announces MMJ International Holdings, a pharmaceutical company whose focus is plant-derived cannabis products for therapeutic purposes, has requested permission to ship tetrahydrocannabinol (THC) and cannabidiol (CBD) from Canada to the U.S. to be used in upcoming clinical trials for people with multiple sclerosis (MS) and Huntington’s disease. MMJ-001…
July 15, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Gadolinium Study, Breath Test for MS Diagnosis, CBD Treatment Trial, Potential Remyelination Therapy Study Examines Gadolinium Deposits in MS Patientsā Brains, But Still Canāt Determine Relationship with Disease Severity Here’s some new information about gadodiamide, a contrast dye that is injected during some MRIs. The study confirms that gadolinium, the substance on which gadodiamide is based, builds up in the brain, but…
July 12, 2019 News by Patricia Inacio, PhD Phase 2 Trial Testing NurOwn Therapy for Progressive MS Adds Third Clinical Site The Phase 2 clinical trial testing BrainStorm Cell Therapeuticās investigationalĀ NurOwnĀ therapy for progressive multiple sclerosis (MS) has added a third clinical site, the company announced. The trial (NCT03799718) now will enroll patients at the Keck School of MedicineĀ ofĀ The University of Southern California (USC), and its academic…
June 28, 2019 News by Patricia Inacio, PhD Less-frequent Dosing with Arbaclofen ER Tablets Decreases Spasticity As Well As Standard Baclofen, MS Trial Data Show Arbaclofen extended-release (ER) tablets taken twice a day can effectively reduce spasticityĀ (muscle stiffness) in patients with multiple sclerosis (MS) with similar potency to that of standard and more-frequently-dosedĀ baclofenĀ (brand name Lioresal), Phase 3 clinical trials show. Latest trial data were presented in two posters during the 33rd Annual Meeting…
June 27, 2019 Columns by Laura Kolaczkowski Could Shortened Infusion Times for Ocrevus Become a Reality? Users of the disease-modifying therapy Ocrevus (ocrelizumab) share a common complaint: the length of time the infusions take. It may seem petty, but an Ocrevus infusion consumes nearly an entire day. My typical infusion involves checking into the clinic, being screened by the infusion nurse for any changes, taking…