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MSBase and icometrix have joined efforts in a large-scale project to identify imaging markers of multiple sclerosis (MS) that could help diagnose the disease in its early stages. The combination of magnetic resonance imaging (MRI) information collected from MS patients with clinical information from the MSBase Registry can offer new insights in disease progression, potentially leading to new predictive tools for MS. It may also promote more standardized use of imaging measures in clinical practice. With more than 52,000 MS patients, the MSBase Registry is an international database committed to collecting patients’ information as well as sharing, tracking and evaluating overall outcome data in MS and other neurological conditions. Until now, the MSBase Registry included only descriptive information regarding patients' imaging analysis results, with no access to full imaging data. This joint, large-scale project will include MRI scan data routinely acquired in clinical setting taking advantage of icometrix’s software platform, MSmetrix. “We wish to unlock the power of MRI for personalized monitoring in MS," Helmut Butzkueven, director of MSBase, said in a press release. "The MSBase Scientific Leadership group has selected MRI integration as the top strategic priority for MSBase. We believe that already conducted MRI scans represent an enormous missed opportunity, because advanced measurements to assess change over time from these scans are not currently in practical use.” Butzkueven said MSBase "will test the predictive power of this unlocking of MRI data in the first phase," with a total of 10,000 MRI data points in at least 3,000 MS patients from all over the world. The project is expected to identify disease progression markers that could help detect early signs of MS by MRI evaluation. This investigator-initiated collaboration between icometrix and the MSBase Foundation is being supported by three global pharmaceutical giants: Novartis, Biogen and Roche. “MRI measures play an essential part in the complex puzzle of MS,” said Danny Bar Zohar, global head of neuroscience development at Novartis. “Partnering with MS Base and icometrix in this exciting project will bring the acquisition of high-quality real world data to the next level, ultimately improving the outcome of people living with MS.”

Innate Immunotherapeutics' MIS416 has failed to help secondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups. Trial participants who received MIS416 had no meaningful improvements in neuromuscular function or the outcome of their disease, compared with those who took received a placebo. “It is disappointing that these results don’t show benefit for people with secondary progressive MS, for whom there are few treatment options,” Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release. Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells, decreasing the inflammation and brain tissue damage associated with MS. Deterioration of the coating is a hallmark of the disease. The one-year trial (NCT02228213) tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week. There were no differences in the groups' scores on a disability index — the expanded disability status scale — or in brain volume changes detected by magnetic resonance imaging. In addition, there were no differences between in disease outcomes that patients reported. The self-reported barometers included the Multiple Sclerosis Impact Scale, the Neurological Fatigue Index, and the Brief Pain Inventory. "I am extremely disappointed by this outcome," Professor Pam McCombe, a principal trial investigator, said in a company press release. "Looking for measurable changes in patients with progressive MS using the assessment tools currently at our disposal is frustrating and complicated. We were hopeful that MIS416 would be an option to treat this group of patients who currently do not have effective treatment options." In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group. The events were mainly related to the first dose, Innate said. The main problems were fever, chills, and muscle weakness. The company has been providing MIS416 to Australian MS patients under a compassionate use program. It said it will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients. Those findings will determine the future of the compassionate use program, it said. “These results are a shock, and definitely not what we were expecting based on our previous clinical experience with MIS416 and the reporting of treatment benefits we have received from many compassionate use patients over an extensive eight-year period," said Simon Wilkinson, Innate Immunotherapeutics' chief executive officer. "These data will be as distressing to them as they will be for all the stakeholders who were relying on the outcome of this study."

The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled “Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. “The existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,” the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. “A longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,” the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.

Problems with sense of smell are more frequent and severe in patients with primary progressive multiple sclerosis (PPMS) than in those with relapsing-remitting multiple sclerosis (RRMS), a study reports. The research, “Olfactory dysfunction in patients with primary progressive MS,” was published in the journal Neurology: Neuroimmunology and Neuroinflammation. A distinguishing feature of RRMS, the most common form of the disease, is attacks of new or increasing neurologic symptoms, such as movement disorders, and then recovery periods. About 15 percent of patients have the primary progressive form, or PPMS. Its main feature is gradually increasing neurologic disability without recovery periods. Some scientists believe PPMS is a less inflammatory course of MS. The differences in the processes that underlie each form are not well understood, however. Several researchers think that studying differences in the two groups' ability to smell — or olfactory dysfunction — could shed light on these underlying processes. Autopsies of MS patients in one study showed that 71 percent had experienced demyelination, or loss of neurons, in the brain's olfactory pathway. The processes that led to this dysfunction were unclear, however. Researchers decided to test the hypothesis that olfactory impairment is more pronounced in patients with PPMS than RRMS. The team examined 32 patients with PPMS, 32 with RRMS, and 32 healthy controls. The yardstick they used to evaluate sense of smell was the olfactory Threshold Discrimination Identification (TDI) Test. It involves patients smelling 48 sniffin' sticks. In addition to an overall TDI, there were subscores on olfactory threshold, odor identification and odor discrimination. Olfactory threshold refers to the lowest concentration of an odor that a person can detect. Researchers found olfactory dysfunction in 27, or 84 percent, of the PPMS patients; 10, or 31 percent, of the RRMS patients; and 1, or 3 percent, of the healthy controls. The TDI score and all subscores were significantly worse in patients with PPMS than in the controls, when considering patients of similar age and the same sex. The TDI score was also worse in PPMS patients than in the RRMS group, after adjusting for age, sex, MS disability level, the length of time patients had the disease, and patients' ability to identify and discriminate among odors. Researchers acknowledged limitations to the study. One was the small size of the groups in the research. Another was not using magnetic resonance imaging, or MRI, to measure olfactory pathway deterioration. Comparing the brain's olfactory pathway region with other brain regions in both the RRMS and PPMS groups could have shed light on the processes underlying the olfactory dysfunction differences between the two, researchers said. “The findings suggest that olfactory dysfunction might be a surrogate of neurodegeneration in these patients," the researchers wrote. "Studies correlating olfactory function with radiologic and clinical markers of disease progression would be of interest.”

The stress of caring for a family member with multiple sclerosis (MS) or another neurodegenerative disease may directly affect the quality of care, according to a study showing that poor caregiver mental health causes higher mortality rates among the patients they care for. The study, published in the journal Proceedings…

A variation in the NLRP1 gene is associated with multiple sclerosis that runs in families, Slovenian researchers report. Their study, “Identification of rare genetic variation of NLRP1 gene in familial multiple sclerosis,” was published in the journal Scientific Reports. The research was led by Dr. Borut Peterlin of Ljubljana University Medical Center's Clinical Institute of Medical Genetics. Scientists believe MS arises from a combination of a person's genetic background and the environment. Although previous studies have suggested that genes are behind MS that runs in families, researchers had yet to confirm that hypothesis. The Slovenian team wanted to identify any genes that were at play in both the MS and malignant melanoma that two siblings had. Although disease surveys indicate the two conditions can occur together, scientists had been unable to identify a shared cause for the two conditions. Interestingly, research has shown a link between a person's susceptibility to MM and a mutation of the NLRP1 gene. And recent studies have indicated that NLRP1 plays a role in the development of MM. The Slovenian team decided to evaluate the association between an NLRP1 mutation and multiple sclerosis in two groups. One consisted of 38 people with MS whose disease ran in the family. The other was 44 people with MS whose disease did not run in their family. Researchers used genomic, molecular biology and immunology measurements to decide whether there was a link between the mutation and MS. They found a connection between the mutation and MS that runs in families. The mutation affects the function of the protein the gene generates — a protein known to be involved in inflammatory processes. Researchers also found other NLRP1 mutations in patients with and without a family history of MS that they believe could be involved in the development of the disease. In addition, the team found evidence of a connection between MS associated with NLRP1 mutations and the development of MM. That evidence involved immune responses to the two conditions. Stimulating the production of immune-system components known as peripheral blood mononuclear cells, or PBMCs, triggered immune responses in MS patients with NLRP1 mutations. The responses included increased production of the pro-inflammatory cytokine IL-1β. Higher levels of that protein have been found in MM tissue. PBMCs include such immune cells as lymphocytes, monocytes, and macrophages. "IL-1β has been implicated in a variety of inflammatory and neurodegenerative processes occurring in MS,” the researchers wrote. Overall, the findings demonstrated an association between MS running in families and MM, they said. And the genetic link between the two may be the NLRP1 gene mutation, they added. The team said scientists might be able to develop a treatment for MS by finding a way to lower the increased production of IL-1β that NLRP1 mutations trigger.

TG Therapeutics’ investigational treatment — ublituximab (TG-1101) — led to a near total depletion of B-cells in patients with relapsing forms of multiple sclerosis (MS) taking part in an ongoing Phase 2 trial, the company recently announced. In addition, the company said that ublituximab had an infusion time as short as one hour, without excessive side…

Merck’s cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve the tablets. “The positive opinion from the CHMP [the committee] is an extraordinary…

A recent study has found Tysabri (natalizumab) treatment for two years to be efficient and safe in Japanese patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Safety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial,” appeared in the journal…

The Multiple Sclerosis Association of America (MSAA) has released three new resources for people with multiple sclerosis (MS), available for free as both printed and online versions on MSAA’s website. According to a press release, the three new resources are: A cover story in the latest edition of MSAA’s…

Lemtrada (alemtuzumab) may be an effective option for relapsing-remitting multiple sclerosis (RRMS) patients withdrawing from prior treatment with Tysabri (natalizumab), an Italian study shows. The study, “High-Risk PML Patients Switching from Natalizumab to Alemtuzumab: an Observational Study,” appeared in the journal Neurology and Therapy. Tysabri, an antibody with…

Ocrevus (ocrelizumab) significantly reduces disease activity and disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive MS (PPMS), according to results of post-hoc analyses of Genentech’s Phase 3 clinical trial program assessing the drug.

Shared decision-making between patients and their doctors and healthcare providers was considered a critical step in the process of treating multiple sclerosis (MS), according to an article published in the journal Practical Neurology. The article “Shared Decision-making in Multiple Sclerosis Management” was written by Amy Perrin Ross, a board-certified…

Multiple sclerosis patients taking Tecfidera, or dimethyl fumarate, were more productive at work than those on Copaxone or beta-interferon therapies, according to a study. Tecfidera also increased patients’ quality of life, researchers said. The study covered patients with relapsing-remitting multiple sclerosis, or RRMS. The four beta-interferon treatments were Avonex, Betaseron, Rebif,…

Stephen L. Hauser, MD, director of the University of California, San Francisco (UCSF)‘s Weill Institute for Neurosciences, has been awarded the 2017 Taubman Prize for Excellence in Translational Medical Research. Recognized for scientific work that challenged the way multiple sclerosis (MS) is regarded, Hauser’s discoveries have opened new therapeutic…

Heidi Redl was in the physically demanding job of ranching when a doctor told her in 2004 that she had multiple sclerosis. Reluctant to give up her physical capabilities without a fight, the horseback rider and runner from Williams Lake, Canada, searched for unconventional as well as conventional MS treatments. In…

Fatigue and limited leg function are more common among older people with progressive multiple sclerosis than in those with relapsing forms of the disease, according to a study. In fact, they are a sign that the disease of a person with relapsing MS is becoming worse by reaching the progressive MS…

Physical disability may have no link to brain lesion volume in some patients with multiple sclerosis (MS), concludes a recent study led by Dr. Rohit Bakshi, a neurology and radiology professor at Harvard Medical School. The study, “Characterizing Clinical and MRI Dissociation in Patients with Multiple Sclerosis,” appeared in the Journal…

AXIM Biotechnologies has secured an additional $4 million in institutional financing to advance clinical trials of its cannabinoid therapies for multiple sclerosis (MS) and irritable bowel syndrome. Some of the trials involve a chewing-gum therapy delivery system. The financing will let the company continue developing a patented chewing-gum-delivered therapy for pain and spasticity. AXIM…

Cigarette smoking is certainly no good for you, but it may not necessarily make your primary progressive multiple sclerosis (PPMS) worse, a new study finds. The study, “Smoking does not influence disability accumulation in primary progressive multiple sclerosis,” appeared in the European Journal of Neurology. It contradicts what was…

The U.S. Food and Drug Administration (FDA) has expanded approval of Dysport (abobotulinumtoxinA) for treatment of spasticity in adults, a condition that affects many people in the United States, including multiple sclerosis patients. The decision was based on Dysport’s supplemental Biologics License Application (sBLA)…

The National Multiple Sclerosis (MS) Society has selected research highlights from a recent MS conference in an effort to help make living with the disease less burdensome. Presentations from the May 24-27 annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in New Orleans — which ranged from advice on smartphone apps to diet…

Researchers managed to change the immune system — replacing inflammation with immune tolerance — in a mouse model of multiple sclerosis (MS) using so-called quantum dots, or nano-sized particles carrying pieces of myelin. Experiments with this advanced technological solution may help researchers design MS therapies that are based on promoting regulatory T-cells rather…

Air pollution, particularly tiny inhalable particles around 10 micrometers in diameter, is a likely trigger for relapses in multiple sclerosis patients, a French study reports. The study, “Air pollution by particulate matter PM10 may trigger multiple sclerosis relapses,” was published in the journal Environmental Research. A growing number of epidemiological studies suggest…

The National Institutes of Health (NIH) has awarded a $1 million grant to IQuity, a Nashville-based company looking into novel RNA targets that ultimately benefit patients with multiple sclerosis (MS) and other autoimmune disorders. The NIH grant is part of the institute’s Small Business Innovation Research (SBIR) program.

Eating a diet high in salt won’t worsen or speed up multiple sclerosis (MS) symptoms, concludes a study of MS patients with clinically isolated syndrome (CIS). That contradicts earlier studies by researchers from Argentina, Vermont and elsewhere who warned of a possible link between high sodium consumption and MS. The…

A stressful microenvironment, characterized by low metabolites and low oxygen levels, triggers the generation of immune cells directly implicated in a variety of inflammatory diseases, such as multiple sclerosis (MS). The study, “Cellular Stress in the Context of an Inflammatory Environment Supports TGF-β-Independent T Helper-17 Differentiation,” was…

Patients with secondary progressive multiple sclerosis (SPMS) have a higher burden of illness than patients with relapsing-remitting multiple sclerosis, a new study showed. The study, “Characteristics, burden of illness, and physical functioning of patients with relapsing-remitting and secondary progressive multiple sclerosis: a cross-sectional US survey,” appeared  in…

Previously unpublished results of clinical trials of Lemtrada (alemtuzumab) appears to contain key information as to why many multiple sclerosis patients who use it develop other autoimmune diseases. Researchers looked at the immune cell mix after Lemtrada depleted many of those cells. They discovered that certain B-cells repopulate the body earlier…

The National Multiple Sclerosis Society and a dozen other advocacy groups have banded together to support the Air Carrier Access Amendments Act of 2017, a bill seeking to strengthen the rights of airline passengers and close service gaps often faced by patients with disabilities, including those with multiple sclerosis (MS).