Alice Melão, MSc,  —

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."

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…

Inhibition of the neuroactive opioid growth factor (OGF) alters the blood levels of important pro- and anti-inflammatory proteins in mice with multiple sclerosis (MS)-like disease. The recognition of this regulatory response may represent a new way to monitor disease progression and treatment response in MS. These findings were reported in a study published in the journal Experimental Biology and Medicine, titled “Modulation of the OGF–OGFr pathway alters cytokine profiles in experimental autoimmune encephalomyelitis and multiple sclerosis.” The study was led by researchers at Penn State University. Understanding the underlying mechanisms involved in MS and finding ways to tackle them is crucial for improving early diagnosis, monitoring disease progression, and patient care. For many years, researchers at Penn State have been focused on understanding the benefits of low-dose naltrexone and its relation with OGF in health and disease, including MS. Naltrexone is marketed with the brand name ReVia, among others. This drug is used routinely off-label to treat MS and other autoimmune diseases, as it has demonstrated to it can reduce fatigue, lessen pain, and confer a general feeling of well-being to patients. Its mode of action is not fully understood, but it is known to block the interaction of the neuroactive OGF with its receptor OGFr. In addition, low-dose naltrexone and OGF were shown to prevent the proliferation of active immune cells in mice with MS-like disease. To further evaluate the role of OGF and low-dose naltrexone in MS, researchers treated mice with naltrexone and analyzed its impact on blood levels of pro- and anti-inflammatory signaling proteins (cytokines). Results showed that after 10 days, MS mice had increased levels in seven out of 10 tested cytokines. Treatment with OGF or low-dose naltrexone was found to specifically increase the levels of the pro-inflammatory IL-6 cytokine, and significantly reduce the levels of anti-inflammatory IL-10 protein. Two other pro-inflammatory proteins, TNF-α and IFN-γ, also were found to be increased in MS mice compared to healthy animals. While TNF-α levels were unaltered upon OGF or low-dose naltrexone treatment, IFN-γ was reduced at 10 days, but still present at higher-than-normal levels after 20 days of therapy. To validate its findings, the team analyzed the levels of the identified signaling proteins in blood samples collected from 14 MS patients and eight non-MS volunteers. Six MS patients were undergoing treatment with Copaxone (glatiramer acetate), and four of them had relapsing-remitting MS (RRMS). Four other RRMS patients and one primary progressive MS (PPMS) patient were receiving Copaxone plus low-dose naltrexone; three RRMS patients were receiving low-dose naltrexone alone. The analysis revealed that IL-10 serum values were comparable between non-MS controls and all MS patients on low-dose naltrexone alone, or Copaxone alone. Patients treated with both Copaxone and naltrexone presented a broad range of IL-10 serum values “that were significantly different from MS subjects receiving LDN [low-dose naltrexone] only,” the researchers wrote. In contrast, IL-6 cytokine was found to be significantly elevated in MS patients treated only with Copaxone compared to patients receiving low-dose naltrexone alone or together with Copaxone. “These data suggest that IL-6, a pro-inflammatory marker is very responsive to OGF and LDN therapy, and thus may be involved in other mechanistic pathways associated with the OGF-OGFr axis,” the researchers wrote. "Identification of inflammatory cytokines that have expression profiles mediated by OGF or LDN [low-dose naltrexone] therapy increase our panel of potential biomarkers for MS,” Patricia McLaughlin, PhD, said in a press release. McLaughlin is professor of neural and behavioral sciences at Penn State, and senior author of the study. “We hope that continued research will identify more specific cytokines and allow us to assemble a reliable panel of minimally invasive biomarkers related to the etiology and progression of MS," she added. Additional long-term human and mouse studies are needed to further evaluate if IL-6 and IL-10 are “appropriate markers to monitor progression of MS,” the researchers emphasized. Still, the team believes this study demonstrates that at least IL-6, IL-10, TNF-α, and IFN-γ, together with OGF, can be useful biomarkers to monitor MS. "McLaughlin and colleagues have researched OGF signaling for several decades, and this seminal discovery of dysregulation in OGF expression in MS patients, and animal models, is very exciting and could lead to prognostic biomarkers for this autoimmune disorder," concluded Steven R. Goodman, PhD, editor-in-chief of the journal in which the study was published.

Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), following Health Canada‘s decision to approve its use with restrictions. Roche/Genentech’s Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of…

Use of medicinal cannabis may pose risks as it may trigger psychiatric problems, but also because it lacks standardized chemical composition, according to a study published in the Journal of the American Osteopathic Association. With the legalization of cannabis in some states for medicinal and recreational proposes, additional pressure…

A stem cell treatment improved the neurological symptoms of three-fourths of the multiple sclerosis patients in a Phase 1 clinical trial, New York researchers reported. The results prompted the team at the Tisch MS Research Center of New York to start a Phase 2 trial to further assess the therapy’s…

A combination of an anti-viral therapy and the anti-depressive mirtazapine can stop the worsening of an infection linked to the multiple sclerosis therapy Tysabri (natalizumab), a case study suggests. The infection, John Cunninghan polyomavirus, can cause a potentially fatal brain infection known as  progressive multifocal leukoencephalopathy, or PML. Both…

Ampyra (dalfampridine), approved to treat walking difficulties in multiple sclerosis (MS) patients, also helps with cognition and movement in the upper and lower extremities, according to a recent scientific presentation. These findings were reported at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in…

A specially tailored program focused on balance and eye-movement exercises can help multiple sclerosis (MS) patients improve balance, dizziness, fatigue, and quality of life, according to a…

Changing from injectable disease-modifying therapies (DMTs) to Gilenya (fingolimod) can benefit people with relapsing multiple sclerosis (MS), regardless of prior therapy regimens. The PREFERMS Phase 4 trial (NCT01623596) concluded that Gilenya, marketed by Novartis, reduces annualized relapse rates (ARR) and brain volume loss (BVL) in both…

Britain’s Multiple Sclerosis Trust is asking patients to help them get the National Health Service to cover Ocrevus (ocrelizumab) as a treatment for primary progressive multiple sclerosis, or PPMS. The key step is trying to persuade the National Institute for Health and Care Excellence to recommend that the health service…

A molecule triggered by the male hormone testosterone protects male mice from developing multiple sclerosis, Northwestern Medicine researchers report. Their discovery may help explain why MS affects more women than men. It could also lead to targeted therapies to protect women against the disease. The study, “…

Registrations are now open for the 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), set for May 30-June 2 at the Music City Center in Nashville, Tennessee. The CMSC Annual Meeting is the nation’s largest educational conference and professional development event for healthcare practitioners, researchers and…

One single session of non-invasive brain stimulation can reduce cognitive fatigue in patients with multiple sclerosis (MS), say researchers at Germany’s Otto-von-Guericke University Magdeburg. Their study, “Electrophysiological and behavioral effects of frontal transcranial direct current stimulation on cognitive fatigue in multiple sclerosis,” appeared in the…

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on  Novartis’ Gilenya (fingolimod) are likely to experience a surge in disease activity if they stop the treatment, researchers in Turkey report. The study, which dealt with patients with relapsing forms of MS, referred to the surge as "severe disease reactivation," or SDR. Researchers published their article, “Factors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,” in the journal The Neurologist. Studies have shown that Gilenya, which the U.S. Food and Drug Administration approved in 2010, can benefit adults with relapsing MS. It reduces annualized relapse rates and prevents more brain lesions from forming, compared with standard interferon treatments. Lesions are damaged nerve cell areas. Despite its benefits, Gilenya is not recommended for patients with heart or liver problems, low levels of white blood cells, severe herpes virus infections or other infections. Also, patients who do not respond to Gilenya and women who are planning to become pregnant are advised to stop the treatment. Discontinuing Gilenya can lead to a return to pretreatment disease activity, or severe disease reactivation, in some patients. It is unclear why this happens and why it affects only some patients. To better understand what risk factors could be associated with reactivation, a team at Istanbul University compared the demographic and disease features of patients who developed SDR after stopping treatment with Gilenya. SDR was defined as including these elements within 6 months of Gilenya discontinuation: more than 5 gadolinium-enhanced lesions or a tumefactive demyelinating lesion detectable by magnetic resonance imaging, the disease progressing to the point that additional treatment with methylprednisolone or plasma exchange was required, and progressive physical disability reflected by a 1-point or more increase in patients' scores on the Expanded Disability Status Scale, or EDSS, Thirty-one patients at the university’s MS clinic who had discontinued Gilenya were included in the study. Eight experienced SDR and 11 relapses. The mean time for SDR patients' reactivation to occur was 2.6 months, researchers said. Patients had significantly higher levels of lymphocytes — white blood cells involved in autoimmunity — than during Gilenya treatment. When the team compared the disease features of SDR and non-SDR patients, they found that SDR patients had significantly higher annualized relapse rates before starting Gilenya and lower EDSS scores. “A higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,” the researchers wrote. “Patients who had higher ARRs before fingolimod [Gilenya] treatment must be closely followed up both clinically and radiologically in terms of the early signs of severe reactivation,” they wrote. About 38 percent of the SDR patients failed to respond to steroid treatment. They received a plasma exchange, which led to moderate improvement in their condition. Based on this finding, the researchers suggested that “plasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.” "In conclusion, SDR may be observed within the first 3 months after cessation of fingolimod," the team wrote. "This may be explained by the rapid influx of lymphocytes into the CNS [central nervous system]. Patients with higher annualized relapse rates and lower Expanded Disability Status Scale scores before commencing fingolimod treatment were more likely to exhibit SDR."  

A British board that recommends what treatments the National Health Service should cover has advised the system to use only Extavia (interferon beta 1b) as a treatment for MS patients who continue to have relapses. Cost was at the heart of the National Institute for Health and Care…

American CryoStem has received a warning letter from the U.S. Food and Drug Administration (FDA) for marketing its adipose-derived stem cell product Atcell without required regulatory approval, and for "significant deviations" from manufacturing processes that potentially raise safety concerns. The company has 15 working days to respond to the concerns raised by the agency and detail how they will be corrected, or risk "enforcement actions," the FDA said in a Jan. 4 press release. Studies suggest that mesenchymal stem cells can be used to alleviate symptoms and possibly treat several degenerative disorders, including multiple sclerosis. Atcell is a therapy based on the ability of mesenchymal stem cells isolated from adipose tissue (fatty tissue) to transform into a subset of mature cells, which include adipose cells, bone cells, and cartilage cells. Although not approved for use, Atcell is being distributed directly to physicians to treat patients affected by several life-threatening diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis, the FDA said in its release. It is administered intravenously, intrathecally (injection or infusion into the central nervous system) or by aerosol inhalation. The product is designed to be used in the same individual (autologous use) the cells are collected from, an approach intended to reduce risk. The cells are extracted using the company’s proprietary Cellect collection system. They are then expanded in the laboratory using the company's ASCelerate SF-M serum free (animal-product free) media, providing compounds needed for the cells to survive and proliferate. Stem cells put through this process are  ready to be used as therapy or to be stored for future use. A recent FDA inspection found that Atcell’s manufacturing steps are not in line with current good manufacturing practice requirements. Specifically, the manipulation of the adipose tissue was more than "minimal," the FDA reported, changing "relevant characteristics" of the original tissue that could introduce contamination by microorganisms or product defects and represent a "risk of harm" to patients. Because of this manipulation, FDA review is required by law to ensure Atcell's safety and efficacy, the agency said. Evidence of an inadequately controlled manipulation environment, lack of control of components used in production, and insufficient and inadequately validated product testing were also reported. “The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective,” Marks added. American CyroStem, based in New Jersey, did respond to observations raised by the FDA at the time of its inspection. But they were found inadequate to support Atcell’s marketing, and failed to acknowledge that FDA approval was required, either by filing a biological license or investigational new drug application. “As part of our comprehensive policy framework for the efficient development and regulation of cell-based regenerative medicine, we’re going to be stepping up enforcement activities against those who manufacture and market products in ways that put patients at risk,” said Scott Gottlieb, FDA commissioner. “We see great promise from the field of cell based regenerative medicine, but there are also novel risks,” Gottlieb added. Healthcare professionals and patients who have used Atcell are asked to report any adverse events related to the treatment using the FDA’s MedWatch Online Voluntary Reporting Form. Completed forms can be submitted online, or via fax to 1-800-FDA-0178.  

An international panel of multiple sclerosis (MS) experts has proposed revising the McDonald criteria guidelines to improve and expedite the diagnosis of this disease. Co-chaired by Dr. Jeffrey Cohen of the Cleveland Clinic and Dr. Alan Thompson of the University College London, the 30-member panel reviewed newly available research…

A deterioration in multiple sclerosis patients' handwriting aligns with drops in their movement, sensory and cognitive skills, a study reports. MS includes loss of hand dexterity and finger movement control. This affects a patient's capacity to manipulate objects and coordinate hand movement, skills needed in handwriting. Previous studies have shown that MS patients had less handwriting rhythm and control than healthy people. This time researchers decided to compare the handwriting movements of both MS patients and healthy volunteers. The research involved 19 MS patients and 22 healthy age-matched controls. The team asked participants to write a specific sentence on a digitizing tablet. They discovered that the way MS patients wrote was much different than those of the controls. The patients took a lot longer to write each word and to achieve spacing between words. This led to them taking a much longer time overall to write a sentence than healthy people. In addition, analysis of handwriting strokes showed that MS patients' writing wasn't as smooth as that of healthy people. Researchers also found a correlation between patients’ movement abilities and cognitive status on the one hand and their handwriting ability on the other. The team said it believed “these findings might be very useful when planning rehabilitative task-oriented interventions focused on handwriting abilities.” In fact, rehabilitation specialists should consider evaluating “both the motor movement and the cognitive status of PwMS [patients with MS] in order to tailor the intervention."

The U.S. Food and Drug Administration has given fingolimod a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. Novartis is marketing it in the United States under the brand name Gilenya for adults with relapsing MS. It has yet to approved…

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."

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.

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.

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.  

Exposure to certain gut bacteria at a young age may cause multiple sclerosis (MS) and fuel its progression, a new mouse study shows. The study, “Gut dysbiosis breaks immunological tolerance toward the central nervous system during young adulthood,” appeared in the journal Proceedings of the National…

U.S. nurses and physicians’ assistants prescribe antibody-based disease-modifying therapies to their multiple sclerosis patients more than neurologists do, a survey indicates. The trend has been for the doctors to stick with interferon therapies, the study said. Antibody-based disease-modifying therapies are also known as monoclonal antibodies. They are designed to harness the…

Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS are one step closer to accessing Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion — announced in a press release issued Nov. 10 by the EMA’s Committee for Medicinal Products for Human Use — is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whether Ocrevus should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens, any decisions on price or insurance reimbursements will be the responsibility of each member state. Ocrevus won U.S. approval earlier this year. It was also recently approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division of Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Serono’s approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.

Longevity Biotech has received a $316,384 grant from the National MS Society to see if LBT-3627, the nerve cell-protecting therapy it has tested in Parkinson’s, can work in multiple sclerosis as well. The company designed the therapy to protect and repair damaged nerve cells and restore balance to the out-of-whack immune response associated…

A blood-clotting protein called fibrinogen prevents myelin production and blocks the neuron remyelination repair process in mice, a study finds. The study, “Fibrinogen Activates BMP Signaling in Oligodendrocyte Progenitor Cells and Inhibits Remyelination after Vascular Damage,” appeared in the journal Neuron. Its conclusions offer new insights and…

Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis — has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.