October 27, 2017 News by Patricia Silva, PhD #MSParis2017 ā Phase 3 Trial Data Show Ozanimod Safe, Effective in MS Patients Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi,Ā from theĀ Vita-SaluteĀ San RaffaeleĀ University, in Italy, announced the results in a presentation during the ongoing…
October 19, 2017 News by Patricia Silva, PhD #MSParis2017 – TG Therapeuticsā Ublituximab Depletes Harmful B-cells and Lowers MRI Lesions, Trial Shows TG TherapeuticsāĀ ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis,Ā according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition,Ā ublituximabĀ reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in threeĀ poster presentations at theĀ 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was thatĀ over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions.Ā The speed-up results indicated thatĀ ā if proven effective and safe ā ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.
October 2, 2017 News by Patricia Silva, PhD Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study A five-year study demonstrated that Sanofi-Genzymeās Lemtrada (alemtuzumab) provides long-term benefits forĀ relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…
September 20, 2017 Columns by Mike Knight Data Differences: Better Records, Better Care āIām sorry, these files take forever to copy,ā the woman at the registration desk says, breaking the silence that had settled between us while she uploaded MRI scans from the CD I gave her moments earlier. āI know it can be a…
September 12, 2017 News by Patricia Silva, PhD Swedish Study Suggests Stem Cell Transplants as Possible Treatment for Aggressive RRMS Autologous hematopoietic stem cell transplants for relapsing-remitting multiple sclerosis (RRMS) are superior to currently approved disease-modifying drugs,Ā according to a Swedish studyĀ published in the Journal of Neurology, Neurosurgery & Psychiatry. In addition, says the review, the procedure’s safety profile has improved in the last decade, and is now just…
August 8, 2017 Columns by Ed Tobias ‘Easy Rider’ Dreams? Say Yes to the Motorcycle Reading some social media posts the other day, I found myself humming a line from a late 1960s Arlo Guthrie song: “I don’t want a pickle. Just want to ride on my motor-sickle.” I didn’t think it was possible for someone with MS to ride a “motor-sickle.” It…
July 11, 2017 News by Patricia Silva, PhD Europe Restricts Use of MS Therapy Zinbryta After Liver Damage Cases and a Death The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…
July 10, 2017 News by Charles Moore Experts Call for Tighter Regulation of Stem Cell Therapies in Use at Clinics Worldwide Advertising for stem cell therapies not supported by clinical research ā often made directly to patients and sometimes promoted as a "cure" for diseases like multiple sclerosis or Parkinson's ā is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling such "stem cell tourism" potentially unsafe. Stem cell tourism is the unflattering name given to the practice of encouraging patients to travel outside their home country to undergo such treatment, typicaly at a private clinic. The article, titled "Marketing of unproven stem cellābased interventions: A call to action" and recently published in the journal Science Translational Medicine, was co-authored by scientists with universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of the commercial promotion of stem cell therapies and ongoing resistance to regulatory efforts. Its authors suggest that a coordinated approach, at national and international levels, be focused on "engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments." Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even though those claim often lack or are supported by little evidence . They also noted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially can endanger a patient's life. The researchers emphasize that tighter regulations on stem cell therapy advertising are needed, especially regarding potential clinical benefits. They support the establishment of international regulatory standards for the manufacture and testing of human cell and tissue-based therapies. "Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk," Sarah Chan, a University of Edinburgh Chancellorās Fellow and report co-author, said in a news release. Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices. "Stem cell therapies hold a lot of promise," Chan said, "but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments." According to the release, the report and its recommendations followed the death of two children at a German clinic in 2010. The clinic has since been shut down. Certain stem cell therapies ā mostly involving blood and skin stem cells ā have undergone rigorous testing in clinical trials, the researchers noted. A number of these resulted in aproved treatments for certain blood cancers, and to grow skin grafts for patients with severe burns. Information about the current status of stem cell research and potential uses of stem cell therapies is available on the website EuroStemCell.
May 16, 2017 News by Patricia Silva, PhD Multiple Sclerosis Experts Offer Guidelines on Contraceptive Use Among Women with MS Two studies that recently appeared in theĀ Multiple Sclerosis JournalĀ shed light onĀ how contraceptive use may affect women with MS, as well as how the disease might affect the safety and effectiveness of birth-control medications. Relapsing MS patients treated with older drugs such as interferons and Copaxone (glatiramer acetate) have a…
May 12, 2017 News by Patricia Silva, PhD MSAA’s Dr. Jack Burks Responds to Readers’ Questions About Ocrevus and Its Use Recently approved, Ocrevus (ocrelizumab) should now be available nationwide for patients prescribed the therapy. But as with any new treatment, concerns about safety and practical issues are on many patientsā minds. Multiple Sclerosis News Today asked Dr. Jack Burks ā a neurologist and researcher who servesĀ as chief…
April 27, 2017 News by Patricia Silva, PhD Genentech Highlights Rapid Actions of MS Therapy Ocrevus at AAN Meeting Within the first two months of treatment, Ocrevus (ocrelizumab) reduced relapses in multiple sclerosis (MS) patients by more than half compared to those on Rebif, and almost completely prevented new brain lesions, according to data underscoring the drug’s rapid effects. Researchers from San Francisco-basedĀ Genentech and its Swiss parent…
April 20, 2017 News by Patricia Silva, PhD AAN Annual Meeting Offers First Ocrevus Data Update Since MS Therapy’s Approval by FDA New data on the recently approved multiple sclerosis (MS) drug Ocrevus (ocrelizumab) will be presented at the upcoming American Academy of Neurology (AAN) Annual Meeting 2017, which will take place April 22-28 in Boston. The meeting is the first scientific conference focusing on neurology since the U.S.
April 19, 2017 News by Patricia Silva, PhD Are Ocrevus and Rituxan Similar? Neurologists Respond to Patients’ Concerns While manyĀ multiple sclerosis patients celebrated the recent approval of Ocrevus (ocrelizumab), others argued that the drug is largelyĀ a rebranded version ofĀ rituximab. Rituximab ā sold as Rituxan for indications like non-Hodgkin’s lymphoma,Ā chronic lymphocytic leukemia, andĀ rheumatoid arthritis ā is used off-label to treat relapsing MS. In online forums and social media,…
April 4, 2017 News by Patricia Silva, PhD Transcript of Interview with Dr. Robert Lisak, a Neurologist and MS Expert, About Ocrevus Here is a transcript of the Multiple Sclerosis News Today interview about Ocrevus (ocrelizumab) with Dr. Robert Lisak of the Consortium of Multiple Sclerosis Centers (CMSC). Lisak, a professor of neurology and of immunology and microbiology at Wayne State University School of Medicine, is aĀ former…
April 4, 2017 News by Patricia Silva, PhD Ocrevus Holds Promise, But Needs to Prove Itself in ‘Long Term,’ Says Dr. Robert Lisak with CMSC Interest inĀ Ocrevus (ocrelizumab), the first FDA-approved treatment for bothĀ relapsing and primary progressive multiple sclerosis, isĀ running high among patients and the organization representing them ā as, arguably, are expectations ofĀ its use. But how do physicians involved in MS care view the newcomer? Dr. Robert Lisak (Photo courtesy…
March 20, 2017 News by Patricia Silva, PhD Alkermes Begins Phase 3 Study of ALKS 8700 as Relapsing MS Treatment AlkermesĀ has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better thanĀ Tecfidera…
February 27, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – Novantrone Lowers Relapse Rates over Long Term, But Carries Cancer Risk Ten years after completingĀ treatment with Novantrone (mitoxantrone), a chemotherapy drug, multiple sclerosis (MS) patients showed evidence of markedly lowerĀ annualized relapse rates, but the therapy’s effects began to wane after five years, a studyĀ presented atĀ ACTRIMS 2017 ForumĀ reported. The study also assessed howĀ Novantrone affects disease progression in primary and secondary progressive…
February 24, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – 3 Trials Show MS Patients Receiving Ocrevus Had No Elevated Infection Risk A detailed analysis ofĀ relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections ā serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…
February 3, 2017 News by Patricia Silva, PhD How MS Patients Judge Their Treatments Differs from Doctors’ Views, Study Reports Considerable differences exist in how multiple sclerosis patients, healthcare providers and insurance companies assess the value of current MS treatments, according to a literature review study by the data analysis firmĀ Real Endpoints. ForĀ the study, a team of clinicians and researchers looked at more thanĀ 300 research articles, covering topics like…
August 15, 2016 News by Patricia Silva, PhD New Pre-HSCT Treatment May Make Stem Cell Transplants a Safer Option for MS Patients Scientists at Stanford University School of Medicine have developed a method for stem cell transplants that may doĀ away with the need for prior systematic treatment with chemotherapy or radiotherapy. If successful, stem cell transplants could be an option for patients with multiple sclerosis (MS), an option nowĀ limited by the…
July 15, 2016 Columns by admin Patients Need To Know What Drugs Do Inside Our Bodies Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis ā according to Biogen, the company that developed it. Thatās good news, and something we need to know. The company agrees that for some time, the long-term effectiveness and safety of this oral…
July 5, 2016 News by Katie McCallum Latest Findings on RRMS Oral Therapy Tecfidera (Dimethyl Fumarate) Detailed in New Report Since its approval by the U.S. Food and Drug Administration (FDA) in 2013,Ā TecfideraĀ (dimethyl fumarate) has emerged as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). While two separate clinical trials demonstrated Tecfidera’s ability to significantly reduce both the rate of relapse…