More relapsing multiple sclerosis (MS) patients given ublituximab remained relapse-free over the two-year long Phase 3 ULTIMATE clinical trials, compared to those given Aubagio (teriflunomide), new data show. “The prevention of relapses represents an important goal of disease-modifying therapy with the potential for a marked impact on the accumulation of disability,” Lawrence Steinman,…
clinical trials
Progressive MS Trial Finds Repeat Bone Marrow Infusion Safe, Feasible Two bone marrow transplant studies are reported in this story. The first, a tiny trial of just six people, assessed the safety of this procedure, which involves harvesting cells from their bone marrow, then infusing them into the bloodstream…
The National Medical Products Administration (NMPA) of China has agreed to approve a Phase 2 trial testing the safety and efficacy of the investigational therapy SN1011 in people with multiple sclerosis (MS). SN1011 is being developed by SinoMab Bioscience to treat a range of autoimmune and inflammatory…
Atara Biotherapeutics plans to launch two Phase 3 clinical trials of its investigational immunotherapy ATA188 in people with non-active, progressive forms of multiple sclerosis (MS). Whether efforts for these trials will go forward, however, depends on positive results from an interim analysis of the Phase 2 portion of the…
Repeat harvesting of bone marrow cells and infusing them back into the bloodstream is safe and feasible in people with active progressive multiple sclerosis (MS), according to data from a small, proof-of-concept clinical trial. Results were detailed in the study, “Repeat infusion of autologous bone marrow…
A Phase 1/2 clinical trial evaluating Imcyse’s experimental therapy IMCY-0141 in people with relapsing-remitting multiple sclerosis (RRMS) has dosed its first patient. The trial, called IMCY-MS-001, is expected to enroll nearly 150 adults with RRMS; sites were not disclosed in a release by the Belgium-based company. Interim results may be available…
An intervention that involves training to recognize facial expressions, and also mimicking these expressions, may help people with multiple sclerosis (MS) who have trouble recognizing facial affect, according to data from a small clinical trial. These findings were reported in the study “Emotional processing intervention (EMOPRINT):…
The Australian government has announced that a record AU$18 million (about $13.5 million) from the Medical Research Future Fund will be used to support research into multiple sclerosis (MS) as part of its 2022–23 budget. Grant opportunities will focus on increasing access to clinical trials and speeding the development of effective…
NVG-291, an experimental therapy designed to promote nervous system repair, has so far been well tolerated in an ongoing Phase 1 study with healthy volunteers. “The Phase 1 study is progressing very well, and we are encouraged by the data we are seeing so far,” Daniel Mikol, MD, PhD, chief…
Nearly three of every four participants in the CONSONANCE clinical trial, which is evaluating Ocrevus (ocrelizumab) in people with primary or secondary progressive multiple sclerosis (MS), showed no evidence of disease progression after a year of treatment. That’s according to new data presented at the American Academy of…
Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data. Information from another trial also…
Ublituximab, an experimental therapy for relapsing multiple sclerosis (MS) patients, outperformed Aubagio on a number of disability-related outcomes in the ULTIMATE clinical trials, new data show. The findings were presented in a series of posters at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in…
The U.S. Food and Drug Administration (FDA) has cleared a Phase 1b/2a trial of PIPE-307, Pipeline Therapeutics‘ investigational myelin-restoring treatment, in people with relapsing-remitting multiple sclerosis (RRMS). The trial will enroll about 45 RRMS patients from multiple U.S. sites who will be randomized to receive either three months…
Eight weeks of hormone therapy was tolerable, and its use may ease the hot flashes and greater disease-related disability this life transition can cause in menopausal women with multiple sclerosis (MS), according to results of a small Phase 1b/2a trial of Duavee, an approved therapy. Public concerns over the safety of…
Higher doses of temelimab were generally safe and resulted in beneficial trends on key neurodegeneration markers in adults with relapsing forms of multiple sclerosis (MS) who already were on rituximab treatment, according to top-line data from the ProTEct-MS Phase 2 clinical trial. While the study’s small size…
NervGen Pharma has been cleared to enroll a second group of healthy volunteers into the multiple ascending dose portion of its Phase 1 clinical trial of NVG-291, a therapeutic candidate for multiple sclerosis (MS). The trial’s Safety Review Committee approved the second group after seeing promising safety data…
PIPE-307, an investigational myelin-restoring medication being developed by Pipeline Therapeutics for the treatment of multiple sclerosis (MS), appears to be safe and well tolerated in healthy adults. The results are from a Phase 1 clinical trial (NCT04725175) that evaluated the safety and tolerability of PIPE-307 in 70…
The National MS Society, together with a number of its corporate healthcare partners, want to help correct the lack of diversity in clinical trials as part of an effort toward resolving healthcare inequities in the MS community. To address these disparities, the National MS Society’s Corporate Healthcare Roundtable, a…
Administering the stem cell therapy NG-01 — designed to have neuroprotective and neuro-regenerative properties — directly into the spinal canal can significantly reduce the levels of neurofilament light chain (NfL), a neuronal damage biomarker, in people with active, progressive forms of multiple sclerosis (MS). These are the new…
Masitinib, AB Science’s experimental oral therapy, significantly slows disability progression in adults with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive MS (SPMS), according to final data from the AB07002 Phase 2b/3 clinical trial. These findings, indicating that the trial met its main goal, support…
The experimental medication ublituximab significantly reduces the number of new brain lesions with severe nerve cell degeneration in people with relapsing multiple sclerosis (MS) as compared with Aubagio (teriflunomide), according to new data from the Phase 3 ULTIMATE clinical trials. The findings showed that ublituximab induces a rapid…
Machine learning — using computer algorithms — can be used to identify people with primary progressive multiple sclerosis (PPMS) who are more likely to respond to treatment, a new study shows. The ability to predict treatment response could allow clinical trials to be designed more efficiently, researchers said. Jean-Pierre…
Synaptogenix announced plans to advance bryostatin-1, its lead candidate, into clinical trials for multiple sclerosis (MS), marking the third neurological disease the small molecule therapy is being developed to potentially treat. “Multiple sclerosis joins Alzheimer’s disease (“AD”) and Fragile X syndrome as our third indication with potential clinical…
Multiple sclerosis (MS) patients who experience reductions in spasticity after a four-week course of inpatient rehabilitation can sustain those improvements in the long term using an app-based self-training program, according to data from a clinical trial. The app also led to better adherence to the self-training program than…
VISIONARY-MS, a Phase 2 clinical trial evaluating the safety and effectiveness of CNM-Au8 in people with relapsing multiple sclerosis (MS) with disease-related visual impairment, will conclude early due to COVID-19 pandemic-related challenges. The release of trial data is expected in the second half of this year, according to…
The Swedish Medical Products Agency has approved AB Science’s request to launch in the country a confirmatory Phase 3 clinical trial of its lead candidate masitinib in adults with primary progressive multiple sclerosis (PPMS) and nonactive secondary progressive MS (SPMS). The decision comes on the heels of a similar authorization by the…
As usual, I’ve gone for what I hope to be an intriguing headline, because you’ve got to grab a reader by any means necessary. If you’ve read this far, I’m winning! This saga goes back well over a year, when my neurologist suggested I participate in a clinical trial for…
A novel algorithm that combines genetic, environmental, and clinical data could be useful for predicting whether people with a first onset of multiple sclerosis (MS)-like disease — known as clinically isolated syndrome (CIS) — will experience relapses or a worsening of their disease over time. The…
A Phase 2 clinical trial into the safety and tolerability of higher-dose temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer, GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…
A Kessler Foundation scientist has been awarded nearly $600,000 to support the development and testing of a behavioral therapy intervention aiming to improve quality of life for people with multiple sclerosis (MS). An upcoming clinical trial into the intervention (NCT05195320), expected to begin…
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