treatment

The laboratory-generated antibody GNbAC1 continued to limit brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and Servier were reporting on the 12-month results of a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…

Topline results of an exploratory Phase 2 clinical trial revealed that Flex Pharma‘s treatment candidate FLX-787 improves muscle cramps, spasms and muscle stiffness in patients with multiple sclerosis (MS). The double-blinded trial, conducted in Australia, evaluated an oral dose of 19 mg FLX-787, taken twice daily in liquid…

A year after U.S. regulators approved Genentech’s Ocrevus (ocrelizumab) as the first treatment for both the relapsing and progressive forms of multiple sclerosis, a prominent neurologist involved in the Phase 3 clinical trials that led to its authorization says it has been beneficial for some MS patients. But it’s simply…

Cigarette smoking increases the relapse rate in patients with relapsing-remitting multiple sclerosis who are being treated with interferon-beta, a study suggests. The findings suggest that RRMS patients who smoke may have fewer relapses if they quit. An article on the results, “Smoking affects the interferon beta treatment response in multiple sclerosis,” appeared in the journal Neurology. A number of studies have looked at the link between environmental and lifestyle factors and the risk of developing MS. These factors include how much sunlight and vitamin D patients get and whether they have an Epstein-Barr virus infection. Cigarette smoking is a well-documented risk factor in MS, but most of the studies on it have focused on the link between smoking and MS, or the link between smoking and the  disease's progression. “Studies that addressed the relationship between smoking and disease activity in RRMS are rarer,” the researchers wrote. The team decided to investigate whether smoking during interferon-beta treatment would affect relapse rates. Previous research had set the stage for the study by showing a link between smoking and gene mutations that make people more susceptible to developing MS. The mutations were in the HLA and NAT1 genes. The team looked at DNA from 834 RRMS patients in the Danish Multiple Sclerosis Biobank who were treated with interferon-beta. Well-known brand names of the treatment include Rebif, Avonex, and Plegridy. There are also other brand names and biosimilar drugs. Researchers also looked at patients’ medical records two years before they started on interferon-beta. Before making any conclusions on possible links between smoking and patients' relapse rate, the team adjusted for patients’ sex, age at the start of treatment, and number of relapses in the two years before treatment began. Their key conclusion was that smoking increased by more than a quarter the number of relapses in patients on interferon-beta therapy. “Each pack of cigarettes more per day during IFN-β [interferon-beta] treatment increased the number of relapses by 27%,” the team wrote. The researchers found no association among smoking, relapses, and mutations of the HLA or NAT1 genes. “Our results confirm that lifestyle factors are important in MS, suggesting that smoking cessation may be associated with a reduction in disease activity,” they wrote. “Although not formally proving that smoking cessation will decrease disease activity in RRMS, the results should encourage physicians to inform patients with MS about the harmful effect of smoking and increase focus on smoking cessation,” they observed.

Six months ago, I was a reasonably svelte 14 and a half stone. I’m not sure how I managed it, but it was certainly before pitting edema wrapped itself around my shins and calves like bulbous sacks of wineskins. I managed to get on the scales a while…

Emerald Health‘s investigational cannabidiol-derived EHP-101 reduces neuroinflammation, the risk of loss of myelin, and nerve cell damage in two mouse models of multiple sclerosis (MS), a new study shows. These results support the potential therapeutic benefits of EHP-101 for MS, and Emerald Health Pharmaceuticals expects to launch a human…

Medical cannabis is a safe and effective treatment for pain relief and should be integrated into current clinical practice, according to a new evidence overview. Benefits also include reduced spasticity in multiple sclerosis patients. The overview, titled “Special Issue: Cannabis in Medicine,” was published in the…

Symbiotix Biotherapies has gained access to Harvard University material that could help it develop treatments for autoimmune and inflammatory diseases like multiple sclerosis and inflammatory bowel diseases. It obtained access to the intellectual property, much of which deals with gut bacteria, under a licensing agreement with Harvard. Intellectual property typically includes…

Blood stem cell transplants lead to significant improvements in relapsing-remitting multiple sclerosis patients’ disability, a Phase 3 clinical trial shows. The 110 patients who took part in the MIST study (NCT00273364) were having relapses after receiving standard therapies such as beta interferon, Copaxone (glatiramer acetate), Novantrone (mitoxantrone), Tysabri (natalizumab), Gilenya (fingolimod),…

Treatment with umbilical cord stem cells was found to be safe and leads to sustained improvements in disability and brain lesions of multiple sclerosis (MS) patients, according to a clinical trial. The study, “Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis,” was…

As we all know, the cost of prescription medications can be outrageous. Disease-modifying therapies aside, even with insurance, the medications we get from a pharmacy can take quite a bite out of a budget. Though many people don’t know it, there are times when it can actually be…

New Spherix Report Finds PPMS Treatment Increased Significantly in Past Year Primary progressive MS has, in some eyes, been the stepchild of the disease-modifying therapies. PPMS patients move steadily downhill, and some believe treatments haven’t kept pace with their disease. Now, the research company Spherix has news…

AbobotulinumtoxinA, marketed as Dysport Therapeutic by Ipsen Biopharmaceuticals Canada, was approved by Health Canada for the treatment of lower limb focal spasticity in adults. Focal spasticity is a medical disorder characterized by an abnormal increase in muscular stiffness in one or more muscles, and usually is the result…

Since Genentech‘s Ocrevus was approved a year ago, the treatment rate of primary progressive multiple sclerosis (PPMS) has increased significantly. However, a closer look at the data shows that other disease-modifying therapies (DMTs) are equally responsible for this increase. The findings were reported by Spherix Global Insights in their new study…

The National Multiple Sclerosis Society will award $433,800 to 10 high-risk pilot studies that will quickly evaluate new strategies and interventions and enhance knowledge about multiple sclerosis (MS). According to a press release, the award winners will address different aspects of the disease, including potential treatments for fatigue and loneliness, to improve patients' walking abilities, and a strategy to change gut bacteria effects in MS. The year-long Pilot Research Grant program is a way to support early-stage research projects to quickly test their effectiveness. The MS Society also said that additional projects will be awarded this year. Results of a recent survey of approximately 300 pilot grant recipients revealed the program successfully promotes new ideas and brings new researchers to the MS field. About 90 percent of the respondents agreed that the financial support was very important for their research project. In 85 percent of cases, the grant supported new ideas, and in 56 percent it allowed support for additional grants. These pilot grants allow researchers to obtain preliminary data so they can decide to apply for additional funding, if the project looks  promising, or to put the idea to rest.

MMJ Bio Science has become the first company to obtain a Canadian license to produce medical cannabis, with the initial authorization covering products for multiple sclerosis and Huntington’s disease. The Health Canada license allows the company to extract cannabinoids from plants that it grows to produce therapies that will be tested in U.S.

Genetically modified human umbilical cord blood cells can help nerve cells recover the myelin layer necessary for normal functioning, researchers found in a preclinical study. This finding may support the development of cell-based therapeutic approaches to help patients with spinal cord injuries or demyelinating diseases, such as multiple sclerosis (MS).

High levels of a protein called calnexin in the brain may disrupt the blood-brain barrier of patients with multiple sclerosis, a Canadian study suggests. The finding could lead to new treatment strategies to prevent brain damage in MS. The research, “Calnexin is necessary for T cell…

Merck KGaA’s evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…

An exploratory Phase 1/2 clinical trial in primary progressive multiple sclerosis (PPMS) conducted at the National Institutes of Health (NIH) confirms the safety profile of Raxone (idebenone) at a dose of 2,250 mg daily over two years. But no difference in effectiveness was found between the Raxone-treated group and…

One way the body may protect itself from nerve cell inflammation is to have cells in the blood-brain barrier increase their production of a protein that keeps immune cells from entering the brain, researchers in Germany and Canada report. The finding suggests that scientists could develop a multiple sclerosis therapy around the protein, known as EGFL7. It would work by preventing as many inflammation-generating immune cells from entering the brain. The underlying trigger for MS is immune cells crossing the blood-brain barrier to invade the central nervous system (CNS). The barrier is a selective membrane that shields the CNS from general blood circulation. Therapies that prevent immune cells from entering the brain can help control the disease, studies have shown. They include Tysabri (natalizumab, marketed by Biogen). But “as with other highly effective disease-modifying therapies which influence a broad range of peripheral immune cells, potential devastating adverse events limit the use of this therapy as a first-line agent,” the researchers wrote. The team at Mainz University Medical Center in Germany and the University of Montreal wondered if epidermal growth factor-like protein 7 (EGFL7) could prevent the brain inflammation in MS.  Although scientists had not previously linked it to MS, it was shown to regulate the migration of immune cells into breast cancer tumors. The CNS response to the chronic inflammation seen in MS patients and a mouse model of the disease was to increase EGFL7 in the blood-brain barrier, the researchers found. Researchers said the increase prevented pro-inflammatory immune cells from crossing into the CNS. Endothelial cells that line blood capillaries in the blood-brain barrier are the ones that secrete EGFL7. “We postulate that EGFL7 upregulation by BBB-ECs [brain blood barrier-endothelial cells] is induced as a compensatory mechanism to promote survival and recovery of BBB function in neuroinflammatory conditions,” the team wrote. Researchers then tested what happened in mice that lacked EGFL7. They found that the mice developed MS earlier and that their blood-brain barrier membrane was less efficient at keeping immune cells out. Treatment with EGFL7 improved the disease severity in the MS mice and tightened the blood-brain barrier, they said. “In light of our findings, smaller EGFL7 agonists, in development for other diseases, could therefore constitute an appealing therapeutic avenue for MS,” the team concluded.

Novartis and Pear Therapeutics are joining forces to develop novel prescription digital therapeutics to treat patients with schizophrenia and multiple sclerosis (MS). Digital therapeutics are software applications designed to treat diseases and improve clinical outcomes for patients. Combining Novartis’ expertise in biomedical research and clinical development with Pear’s…

Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…

The U.S. Food and Drug Administration has asked Celgene to add more information to its New Drug Application for ozanimod as a treatment for relapsing forms of multiple sclerosis. Celgene said it plans to meet with FDA officials to make sure it understands exactly what new information the agency…

Argentina has become the first country in Latin America to approve Mavenclad (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval covered Merck’s cladribine tablet formulation. Merck expects to make the treatment available in the country in the next few months. Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries. "Having a new MS treatment approved in Argentina is very motivating," Dr. Jorge Correale of the Institute for Neurological Research Dr. Raúl Carrea said in a press release. "Mavenclad allows the patient's immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring," said Correale, head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days' treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors. Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS studies, the Phase 2 ONWARD study, and the long-term PREMIERE study. These trials involved more than 2,700 patients with relapsing MS, some of whom researchers followed for more than 10 years. The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy. The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. "We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad," said Rehan Verjee, the chief marketing and strategy officer of Merck's biopharma business. "Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step."

The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.

Reprogramming skin cells into brain stem cells, then transplanting them into the central nervous system may reduce inflammation and reverse the nerve cell damage in progressive multiple sclerosis, a mouse study shows. Scientists have dubbed macrophages the immune system's big eaters because they engulf abnormal cells like cancer in addition to invaders like viruses and bacteria. Special classes of macrophages live in a number of organs, including the brain and spinal cord, where they’re called microglia. Although they protect the body, microglia can participate in the development of progressive forms of MS by attacking the central nervous system, causing nerve cell damage. MS is an autoimmune disease, or one in which the immune system can attack healthy tissue besides invaders. Recent studies have suggested that neural stem cells, which have the capacity to differentiate into any type of nerve cell, can regulate immune response and inflammation in the central nervous system. At one point, researchers obtained neural stem cells from embryos. But this technique generated only a fraction of the cells needed for treatments. Meanwhile, doctors have tried to avoid collecting stem cells from someone with a different genetic profile than the patient because this increases the risk that the immune system will attack them once they're transplanted. University of Cambridge scientists decided to try reprogramming skin cells into neural stem cells. The idea behind the mouse study was that using skin cells from the same person who will receive the stem cells will reduce the chance that the immune system will attack the stem cells. In the mouse study, the team discovered a link between higher than normal levels of a small metabolite, called succinate, and chronic MS. The metabolite prompts macrophages and microglia to generate inflammation in the cerebrospinal fluid that bathes the brain and spinal cord. Transplanting neural stem cells and progenitors of these stem cells into the cerebrospinal fluid of mice improved the animals' chronic nerve cell inflammation. The stem cells reduced the animals' succinate levels and switched their macrophages and microglia from a pro- to an anti-inflammatory state. This led to a decrease in inflammation and less damage to the central nervous system. “Our mouse study suggests that using a patient’s reprogrammed cells could provide a route to personalized treatment of chronic inflammatory diseases, including progressive forms of MS,” Stefano Pluchino, a principal researcher in Cambridge's Department of Clinical Neurosciences, said in a press release. “This is particularly promising as these cells should be more readily obtainable than conventional neural stem cells and would not carry the risk of an adverse immune response,” said Pluchino, the study's lead author. Luca Peruzzotti-Jametti, a Wellcome Trust research training fellow, said the discovery would not have been possible without a multidisciplinary collaboration. “We made this discovery by bringing together researchers from diverse fields, including regenerative medicine, cancer, mitochondrial biology, inflammation and stroke, and cellular reprogramming."

Pilot Study Is Testing Whether Mediterranean Diet Can Help MS Patients There’s been a good deal of news recently about the possibility that bacteria in our stomachs have an impact on our MS. There’s also been talk, for a long time, about whether certain diets can improve…

Oxygen sensor proteins can regulate immune B-cell activity, preventing inflammation in autoimmune disorders such as multiple sclerosis, a study reports. The research, titled “Hypoxia-inducible factor-1α is a critical transcription factor for IL-10-producing B cells in autoimmune disease,” was published in Nature Communications. An autoimmune disease is one in…

Gilenya (fingolimod) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS) in everyday clinical practice, a new study shows. The therapy was shown to be effective even in patients switching from Tysabri (natalizumab) treatment. The study, “Effectiveness and baseline factors associated to fingolimod response in a…