News

December 14, 2017 News by Iqra Mumal, MSc

Chronic and Neuropathic Pain in MS Patients Should Be Routinely Evaluated, Study Says

Multiple sclerosis patients should be routinely assessed for chronic and, especially, neuropathic pain in order to properly diagnose and treat this condition, which appears to directly affect the degree of a patient's disability, a new study reports. Pain is one of the most disabling clinical symptoms of MS, associated with suffering, distress, and lower quality of life. Many studies have investigated the prevalence of chronic pain in MS patients but with highly varying results: estimates range from 29 percent up to 92 percent. This disparity is likely due to methodological differences between the studies, as well as differences in the studied population. The result is the prevalence of pain in MS is still unclear, and underdiagnoses of pain in this patient population likely. Researchers in Italy conducted a single-center study to determine the prevalence and characteristics of chronic pain, defined as constant pain for more than three months, in a population of MS patients. Pain was evaluated using validated tools, and the results were analyzed in relation to clinical features such as disease duration and disability. In total, 374 MS patients with different disease severities were assessed for pain. Results found an overall prevalence of chronic pain of 52.1, most frequently affecting the lower limbs. Neuropathic pain, which refers to pain resulting from a lesion or disease impacting the sensory nervous system, was the most frequent type of chronic pain, affecting 23.7 percent of the patients analyzed. Pain intensity was also found to be significantly higher in patients with neuropathic pain compared to those with non-neuropathic pain. Researchers measured patients' disability using the Expanded Disability Status Scale. They determined that patients with chronic pain, and especially those with chronic neuropathic pain, had significantly higher EDSS scores (meaning greater disability) than those without such pain. Both these patient groups were also more likely to be on long-term pain medications: 33 percent of MS patients with neuropathic pain, and 24 percent of those with chronic pain. These results indicate that pain is underdiagnosed and undertreated in MS patients, and a factor that may contribute to increased disability. “Our results suggest that clinical disability is higher in MS patients with chronic pain and, in particular, in those with neuropathic pain,” the researchers concluded. “The present study supports the routine assessment of neuropathic pain in MS patients.”

December 11, 2017 News by Alice Melão, MSc

Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on the therapy. Health Canada and the European Commission approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MS studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progression and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."

December 8, 2017 News by Patricia Silva, PhD

Toyota Foundation and Nesta Launch $4 Million Global Challenge to Create ‘Smart’ Mobility Devices

Teams of inventors working to improve mobility for people with lower-limb paralysis, including those with multiple sclerosis (MS), are invited to take part in a $4 million technology challenge launched by Toyota Mobility Foundation and Nesta’s Challenge Prize Centre. The most common causes of lower-limb paralysis are MS, spinal cord injury, and…

December 7, 2017 News by Patricia Silva, PhD

Partners in Huge Cannabis Therapy Operation Planned for Australia Apply for Licenses

Two companies that plan a huge cannabis-growing and research facility in Australia have applied for licenses to run the operations, whose products could benefit multiple sclerosis patients. MYM Nutraceuticals and PUF Ventures Australia asked the Australian Office of Drug Control for both medical cannabis and cannabis research licenses. The applications come at…

December 7, 2017 News by Alice Melão, MSc

University of Illinois Researchers Win $300,000 Falk Award to Improve MS Drug Delivery

A research team at the University of Illinois College of Medicine has received $300,000 from the Falk Medical Research Trust to develop a novel drug delivery method that could improve the treatment of patients with multiple sclerosis. Established in 1979, the Dr. Ralph and Marian Falk Medical Research Trust - Catalyst Award is granted every year to a dozen U.S. research groups. It provides one year of funding to high-risk, high-reward projects to complete preliminary studies. Catalyst Program winners who achieve their goals can then enroll in the Falk Transformational Awards Program, which offers $1 million for two years to further support the projects. The UIC team, led by Ernesto Bongarzone and Maria Givogri, hope to transform naturally occurring small vesicles released by several cell types into drug targeted delivery vehicles. Cells commonly use these vesicles to communicate with each other. They pack inside the vesicles with many cell products, like proteins and small RNA molecules, then release them into the bloodstream and cerebrospinal fluid. These vesicles can travel to distant places in the body until they find and fuse with their target cell, dumping their cargo. However, the content of vesicles may not always be good, as they have been shown to play a role in spreading cancer, said fellow anatomy and cell biology professor Givogri. "There is much more to learn about how they function in this way,” she added. The team will use the Catalyst Award to test different methods of vesicles production from mesenchymal stem cells. They will also engineer these vesicles to specifically target oligodendrocytes in the brain and spinal cord. Oligodendrocytes are cells that specialize in producing the nerve cell’s protective myelin layer. The efficacy and safety of this new delivery method will be tested in mice. After completing these preliminary studies, the team expects to apply for further funding. The UIC researchers plan to use the vesicles to transport and deliver small RNA molecules, called microRNAs, that can boost myelin production.

December 6, 2017 News by Patricia Silva, PhD

National MS Society Endorses US-Canada Registry Aiming to Advance Research and Patient Care

The National Multiple Sclerosis Society has endorsed the North American Registry for Care and Research in Multiple Sclerosis, a collaborative effort involving other multiple sclerosis registries, clinicians, researchers and patients in the U.S. and parts of Canada. NARCRMS is a public-private partnership, bringing together academia, industry, governmental agencies, and nonprofit organizations with an interest in MS. It operates under the auspices of the Consortium of Multiple Sclerosis Centers. It consists of a database of clinical records and patient-centered outcomes, providing clinicians and scientists with a greater and more integrated ability to track the incidence, prevalence and course of MS. Like many registries, NARCRMS includes data collected by physicians, like neuroimaging scans, genetic markers, cognitive assessments and specimen collection, and testing for identification of biomarkers of disease progression. It also adds patient-reported outcomes focused on disease challenges and impacts on daily life. Its goal is to improve the understanding of MS, facilitate multi-level care, and aid in recruiting patients into clinical trials. NARCRMS is the first open-source database to connect MS centers across North America to regional databases by state, region and zip code. To date, NARCRMS has recruited 10 centers, with another three in the process of coming aboard, and has enrolled 113 patients. The registry builds on North American Research Committee on Multiple Sclerosis (NARCOMS), the oldest patient-driven registry in the U.S. using patient experiences to advance MS clinical care and life quality. NARCOMS was created in 1993 by the CMSC. More than 37,500 people had joined the registry as of 2015. Researchers used NARCOMS data on 2014 to report on outcomes in switching treatments, therapy effectiveness, disease progression, co-existing conditions, and other topics that help understand the MS experience.

December 6, 2017 News by Alice Melão, MSc

Health Canada Approves Merck’s Mavenclad to Treat RRMS

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drug’s approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotes long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse rates and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.

December 5, 2017 News by Patricia Inacio, PhD

Human Vaccines Project Studies Aim to Unveil Workings of Immune System

Scientists announced positive and encouraging outcomes from two clinical studies — running as part of the larger Human Vaccines Project — aiming to unravel the mechanisms that underlie our immune system’s ability to fight disease. The results are expected to shed light on unknown aspects of the immune system that scientists at the Human Vaccines Project, a public-private partnership, hope to translate into new trials for diseases linked to the immune system, such as multiple sclerosis. Results from the trials — the Human Immunome Program and the Immunity to Hepatitis B Vaccine study — were recently presented at the World Vaccine and Immunotherapy Congress in San Diego, California. In the ongoing Human Immunome Program, researchers are trying to fill a major knowledge gap in the components and mechanisms of the immune system that allow it to recognize various threats, from viruses, parasites and bacteria to cancer cells. They are using blood samples from healthy people to analyze, at an unprecedented depth, the whole repertoire of genes that make up the surface receptors of immune B- and T-cells, the core cells of the immune system’s defence mechanisms. Results will likely advance how scientists diagnose and treat various diseases, and could prompt the development of new, improved vaccines. "We are studying the immune systems of healthy individuals to identify common elements, which could be important for facilitating new and improved vaccines," James E. Crowe Jr., MD, director of Vanderbilt University Medical Center's Vaccine Center, the leading scientific institution of the Human Immunome Program, said in a press release. Researchers will cross the sequencing information with participants' microbiome composition — the natural community of microbes that reside in an organism and are key for a healthy immune system — and other health and sociodemographic characteristics. "We also plan to expand these studies to complete the catalog across different demographics and geographies and compare healthy subjects with individuals with immune-mediated diseases such as multiple sclerosis, cancer and Alzheimer's, which could also reveal novel diagnostic markers," Crowe said. The second study, the Immunity to Hepatitis B Vaccine trial — currently recruiting participants — aims to understand why some people achieve protection against Hepatitis B after a single vaccine shot, while others require up to three immunizations to acquire full immunity. Understanding why the immune system responds differently in individuals can help researchers improve existing vaccines and potentially lead to one-shot vaccines that provide long-term immunity for all populations. Researchers in this study are analyzing genes belonging to the innate-immune system — a general immune system response, not one tailored to specific threats — and observing that activation of these genes in certain immune cells can predict who will be a responder after a single shot of the Hepatitis B vaccine. Preliminary results of the Immunity to Hepatitis B Vaccine study were delivered in two separate sessions at the congress. One was given by Manish Sadarangani, director of the Vaccine Evaluation Center of the University of British Columbia and BC Children's Hospital Research Institute, and the by and Richard Scheuermann, director of the J. Craig Venter Institute in La Jolla, California. "These preliminary data points toward strategies to understand why some people respond better to vaccines than others," Sadarangani said. "Using single cell analyses, we now have the opportunity to probe vaccine-induced responses more effectively, to not only learn what happens immediately after vaccination, but to monitor responses over time and utilize machine learning to eventually predict the human immune response to vaccines," added Scheuermann. Wayne C. Koff, president and chief executive officer of the Human Vaccines Project, emphasized that researchers are optimistic with the results obtained so far, as they "provide important insights into the scale and complexity of the human immune system and how vaccines confer protective immunity." "With our network of academic and corporate partners, we aim to build on these findings and decode the human immune system, giving the world the tools required to advance the development of future vaccines and therapies to defeat major global diseases," Koff concluded.  

December 5, 2017 News by Marta Figueiredo, PhD

Laquinimod Fails to Slow Brain Atrophy and PPMS Progression, Says Developer Active Biotech

Sweden's Active Biotech said its experimental therapy Laquinimod failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potential to treat primary progressive multiple sclerosis. Laquinimod, also known as Nerventra or ABR-215062, was developed by Active Biotech and Israel's Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod — 0.6 and 1.5 mg/day — in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release, Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression. “There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,” said the company's president and CEO, Helén Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active Biotec stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntington’s disease in a Phase 2 clinical trial.

November 30, 2017 News by Janet Stewart, MSc

Health Costs Higher, But Outcomes Better for MS Patients Who Take Their Meds, Study Finds

Multiple sclerosis patients who adhere strictly to their medication pay more but stay healthier in the long run than those who don't, a study found. Researchers at Liberty University College of Osteopathic Medicine in Lynchburg, Virginia, analyzed data from 2004 to 2013, including electronic health records, insurance claims and self-reported medication adherence. They based their assessment of health outcomes on inpatient admission, emergency room visits, outpatient appointments  and healthcare costs. In total, 681 participants answered questionnaires about medication adherence and disease outcomes, including the Multiple Sclerosis Impact Scale and the Kurtzke Expanded Disability Status Scale. Also used was the Treatment Satisfaction Questionnaire for Medication to assess satisfaction with the medication taken. Patients who took their medicines most rigorously reported 14 percent less severe physical impact of MS, and 17 percent less severe psychological impact than those with low adherence. These patients also reported a 12 percent decrease in disability level, and believed their treatment plan was 7 percent more effective. However, the total overall costs were higher for patients who adhered to their doctor's orders. The researchers said it's more difficult to detect improvements in health outcomes for MS than for other chronic illnesses. This is partly because the only test for changes in disease status is brain imaging, which is expensive and not done routinely. Furthermore, brain imaging only detects new lesions following a relapse, which cannot be compared to previous or future imaging in a quantifiable way. In fact, no simple tests exist for measuring disease severity in MS as there are in other chronic diseases, making it difficult to determine whether treatment benefits justify their cost.

November 29, 2017 News by Patricia Silva, PhD

MMJ Files US Patent for Multiple Sclerosis Cannabinoid Treatment

MMJ International Holdings has applied to the U.S. Patent and Trademark Office (USPTO) for new pharmaceutical compounds and methods to treat and prevent symptoms associated with multiple sclerosis (MS) and other diseases responsive to cannabinoids. The patent covers MMJ BioScience’s intellectual property portfolio, which comprises several patent families…

November 29, 2017 News by Alice Melão, MSc

Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

November 28, 2017 News by Patricia Silva, PhD

European Neurologists Ready to Use Both Mavenclad and Ocrevus, Survey Shows

Mavenclad has become the multiple sclerosis therapy of choice for one in five neurologists in Germany and the United Kingdom, according to a Spherix Global Insights survey. Meanwhile, many European neurologists are looking forward to the continent's approval of Ocrevus, particularly as a treatment for primary progressive multiple sclerosis, or PPMS. The United States approved the therapy in March of 2017. European neurologists are using Mavenclad for both relapsing-remitting multiple sclerosis, or RRMS, and secondary progressive multiple sclerosis, SPMS. The report that Spherix issued on European neurologists' treatment choices is called "RealTime Dynamix: Multiple Sclerosis EU." It was based on a survey of 261 neurologists, who were asked about thei disease-modifying drugs they prescribed and the way they manage MS, according to a press release. The survey focused on Merck KGaA’s Mavenclad, which the European Union approved in August 2017, and Genentech’s Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval by recommending its authorization earlier this month. Mavenclad is the first disease-modifying therapy that most of the patients who are on it have tried, according to the survey. Spherix analysts said this indicates that Mavenclad may expand the proportion of MS patients using disease-modifying drugs. But while Mavenclad’s label allows patients to use it as a first-line therapy, the survey revealed that many neurologists are not comfortable prescribing it as an initial treatment. This suggests that the Mavenclad-treated population may later include more patients who switched treatments, Spherix said. Mavenclad reduces MS relapses by resetting the immune system, studies have shown. Neurologists who prescribe it as a first-line treatment appear to endorse the idea of induction therapy. This approach involves more potent therapies being used from the onset of the disease. British neurologists in particular appear to favor the induction approach, the report revealed. Patients who had been on previous treatments have switched mainly from Copaxone (glatiramer acetate), interferons, or Novartis' Gilenya, the report showed. Many neurologists' lack of familiarity with Mavenclad may be limiting its use, the report said. It noted that two out of five neurologists had not received a detailed briefing on the drug, and more than one-third had not attended any launch activities. Limited market access was the second most common obstacle to Mavenclad prescription, the report indicated. Interestingly, those who had participated in Mavenclad launch activities said these consisted mostly of independent research or discussions with colleagues, rather than activities organized by Mavenclad’s developer Merck KGaA. Spherix’s survey was done just before the European Medicines Agency recommended Ocrevus' approval in mid-November. Even before the endorsement, the survey indicated, Ocrevus was by far the MS drug in development that most neurologists looked forward to using. The reasons, the neurologists said, were its beneficial effectiveness-safety profile, its new mechanism of action, the fact that it only needs to be given once every six months, and a treatment label that includes PPMS. It is the first disease-modifying drug ever approved for PPMS patients. Twice as many neurologists said they look forward to using Ocrevus as a first-line treatment for PPMS as those saying they wanted to use it as a first-line treatment for relapsing MS. And neurologists estimated that twice as many PPMS patients as RRMS patients are appropriate candidates for Ocrevus treatment. In a report in October about U.S. neurologists' treatment preferences, Spherix said those doctors estimated the number of PPMS Ocrevus candidates at three times that of RRMS patients. Nonetheless, about equally as many PPMS and RRMS patients had tried Ocrevus four months after its launch, the survey showed. The European situation may evolve in a similar manner, since the European Medicines Agency recommended a specific use of Ocrevus in PPMS patients. It specified that the drug be used in PPMS patients who show “imaging features characteristic of inflammatory activity." This makes it likely that only a subgroup of PPMS patients will receive the treatment. The use of Biogen's Tysabri, Gilenya, and Rituxan (rituximab), also made by Roche's Genentech subdivision, will be most impacted by Ocrevus' introduction. Despite this, neurologists believe rituximab's use will grow in the next six months, because Ocrevus is still not available, while lower-cost rituximab biosimilars are.

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