PPMS

The Phase 2 clinical trial testing BrainStorm Cell Therapeutic’s investigational NurOwn 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 Medicine of The University of Southern California (USC), and its academic…

Patients with progressive multiple sclerosis (MS) have difficulties perceiving the thoughts and intentions, but not the emotions, of other individuals, Kessler Foundation researchers have found. Those findings were reported in a study, “Cognitive but Not Affective Theory of Mind Deficits in Progressive MS,” that was published in…

Early, positive safety results from a Phase 1 trial testing a potential immunotherapy, ATA188, in people with progressive multiple sclerosis will be detailed at the 5th Congress of the European Academy of Neurology (EAN) late next month, its developer, Atara Biotherapeutics, announced. ATA188 is an investigational and “off-the-shelf”…

After first rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…

Higher exposure to Ocrevus (ocrelizumab) is associated with greater immune B-cell depletion in the blood, and lessened risk of disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive disease (PPMS), according to new research. The study supporting that finding, “Pharmacokinetics, Pharmacodynamics and…

Women with MS Have Higher Prevalence of Sexual Dysfunction, Study Reveals I’m surprised that someone felt it necessary to conduct a formal study of this. A glance at multiple sclerosis (MS) groups on social media, although unscientific, would suggest that this is a common problem. And if you’re going…

Cellular senescence — the process of aging at the cellular level — may play a role in the development of primary progressive multiple sclerosis (PPMS) by limiting the ability of myelin-producing cells (oligodendrocytes) to renew and mature. The study with that finding, “Cellular senescence in progenitor…

Treatment with oral ibudilast slows brain shrinkage in patients with primary progressive multiple sclerosis (PPMS), but not in those with secondary progressive MS (SPMS), according to results of a Phase 2b clinical trial. According to the findings, this could be partially due to faster disease progression in untreated…

Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have completed negotiations ultimately aiming to obtain public funding for Ocrevus (ocrelizumab) as a first-line treatment for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, and as management strategy for patients with early primary progressive MS…

The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants…

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…

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…

More than 21,000 people have signed a petition calling for Ocrevus (ocrelizumab) to be made available by the National Health Service (NHS) in England for people with primary progressive multiple sclerosis (PPMS). According to an MS Trust press release, the…

“If I were you two, I think I’d plan for the worst,” Amy, my physiatrist, said to my wife and me as we sat in the examination room. It was just after 11 a.m. on Friday, Jan. 18. January has become one of two pivotal months in terms of…

Fatigue is more prevalent among patients with progressive multiple sclerosis (MS), according to a study that surveyed patients on fatigue and factors related to it. In addition, increased fatigue severity correlated with greater physical, cognitive, and psychological impairment, although the strength of this link was largely the same…

Treatment with a single dose of Ocrevus (ocrelizumab) depleted a subset of immune T-cells within two weeks in patients with relapsing multiple sclerosis (MS) or primary progressive MS (PPMS), according to a study. The study, “Ocrelizumab Depletes CD20+ T Cells in Multiple Sclerosis Patients,” was published in the journal Cells. Autoreactive immune T-cells, which attack the body’s own tissues, have been regarded as the primary mediator of MS; however, this view has been challenged by the effectiveness of therapies targeting immune B-cells that contain the CD20 cell surface protein in reducing disease activity. One such therapy is Genentech’s Ocrevus, an anti-CD20 monoclonal antibody, which was first approved in the U.S. in 2017 for patients with relapsing MS or PPMS. Because CD20 is mainly expressed by B-cell precursors and mature B-cells, Ocrevus is often considered to selectively deplete CD20-containing B-cells. However, CD20 is also expressed by highly activated T-cells with the CD3 protein marker, characterized by the increased production of proinflammatory molecules, or cytokines. These T-cells are found in the blood, cerebrospinal fluid — the liquid surrounding the brain and spinal cord — and chronic brain lesions of MS patients, and show an elevated expression of the CD8 and CD45 markers. Off-label use of rituximab (marketed as Rituxan in the U.S. and MabThera in Europe), a lymphoma and rheumatoid arthritis treatment that also targets CD20, has been associated with the depletion of CD20-containing T-cells in MS patients. Therefore, targeting this T-cell subtype has been hypothesized as an additional mechanism for rituximab’s clinical effectiveness. However, scientists did not know whether Ocrevus, which is different from rituximab in terms of CD20 binding and cell toxicity, also depletes CD20-positive T-cells. To address this unknown, a team from Hannover Medical School in Germany analyzed blood samples of MS patients through a technique called multicolor flow cytometry prior to the first dose of Ocrevus and after two weeks, immediately before the second dose. They intended to evaluate the characteristics of the patients’ peripheral blood mononuclear cells, which include T-cells, B-cells, monocytes, and macrophages. A total of 21 patients (13 women) were included, with a median age of 43 years (range 22-65 years). Of the participants, 17 had the relapsing form of the disease for a median of 14.6 years, while four had PPMS for a median of 5.6 years. The analysis found T-cells containing CD20 and CD3 in all patients. These cells accounted for 2.4% of all CD45-expressing lymphocytes — white blood cells that include T- and B-cells — and for a significant proportion (18.4%) of all CD20 cells. Evaluation of the cells’ fluorescence intensity revealed that CD20 levels were significantly lower on T-cells than on B-cells also expressing this marker. Treatment with one dose of Ocrevus substantially lowered the levels of CD20-positive T- and B-cells within two weeks, reflected by a frequency of 0.04% and an absolute cell count decrease from 224.9 to 0.57/microliter. “Our results demonstrate that treatment with [Ocrevus] does not exclusively target B-cells, but also CD20+ T-cells, which account for a substantial amount of CD20-expressing cells,” the researchers wrote. “These findings suggest that CD20+ T-cells might play a pivotal role in the pathogenesis of MS, and we speculate that depletion of CD3+CD20+ cells by anti-CD20 monoclonal antibodies might contribute to the efficacy of anti-CD20 therapy,” they added. However, they also emphasized that the findings need to be confirmed in studies with larger groups of MS patients.

The U.S. Food and Drug Administration (FDA) has approved BrainStorm Cell Therapeutics‘ request to open a Phase 2 clinical trial testing the safety and effectiveness of its proprietary NurOwn mesenchymal stem cell (MSC) treatment in progressive multiple sclerosis (MS) patients. The request was in the form of Investigational New Drug…

Atara Biotherapeutics’ 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…

BrainStorm Cell Therapeutics is planning to launch a Phase 2 clinical trial in the United States to evaluate the safety and activity of its lead cell therapy candidate, NurOwn, in people with progressive multiple sclerosis (MS). The company announced that has submitted an Investigational New Drug (IND) application to…

Women with multiple sclerosis are being diagnosed at younger ages and in greater numbers than men, except for those with primary progressive disease (PPMS), where men 50 or older tend to predominate, a European review study that looked at trends over several decades reports. The study “Age‐dependent variation of female…

Treating primary progressive multiple sclerosis (PPMS) patients with Ocrevus (ocrelizumab) can help to preserve strength and function in their hands and the arms, analysis of data from a Phase 3 trial found. The research, “Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive…

A Phase 3 clinical trial intending to confirm the potential of MD1003, a high-dose biotin, in treating progressive multiple sclerosis (MS) patients is completely enrolled, MedDay Pharmaceuticals, the investigational therapy’s developer, announced. The randomized, double-blind, and placebo-controlled study (NCT02936037), called SPI2, follows the previous Phase 3 trial (NCT02220933),…

NICE Postpones Final Opinion on Adding Ocrevus to Public Health System for PPMS Patients in UK This last-minute reprieve from the agency that dictates which medications may be prescribed for patients of the U.K.’s National Health Service (NHS) is welcome news. Last summer, the National Institute for…

A final and weighty opinion regarding whether Ocrevus (ocrelizumab) will be among treatments available at low or no cost to primary progressive multiple sclerosis (PPMS) patients in England and Wales — through the National Health Service (NHS) — has been put on hold, according to the Multiple Sclerosis Trust. The…

Stem cells from patients with Parkinson’s disease and primary progressive multiple sclerosis (PPMS) are soon to voyage into space, and be brought aboard the International Space Station so cell-to-cell interactions in these neurodegenerative diseases can be studied without gravitational forces acting on them. This research project, proposed to launch in May…

Treating patients with primary progressive or relapsing multiple sclerosis (MS) early with Ocrevus (ocrelizumab) is key to slowing disease progression, according to Hideki Garren, global head of Multiple Sclerosis and Neuroimmunology at Genentech. In an interview with Multiple Sclerosis News Today at the recent 34th congress of the European Committee for Treatment…

Tailored, highly effective therapies early in the disease’s course may be a way forward in multiple sclerosis (MS) treatment, according to Cleveland Clinic neurologist Robert Bermel. Another neurologist with the Cleveland Clinic, Robert Fox, talked about potential and upcoming progressive MS treatments.  In interviews with Multiple Sclerosis News…

Measuring the blood level of neurofilament light chain (NfL) may predict brain shrinkage in primary progressive (PPMS) and secondary progressive multiple sclerosis (SPMS), according to a new study. The findings also show that NfL levels are associated with brain lesion load in these patients. The research, “…

When I was diagnosed in 2010 with primary progressive multiple sclerosis (PPMS), I didn’t know what to expect. It quickly became apparent that my doctors didn’t know, either. I’m sure they could have given me some scenarios of what my future might be…

Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieve no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment…