News

#ACTRIMS2019 – Stem Cell Tourism Poses Threat of Complications for Patients, First US Neurologist Survey Says

Academic neurologists are seeing many patients with neurological diseases interested in or receiving unapproved stem cell-based treatments, sometimes with negative health and/or financial consequences, according to a U.S. survey of neurologists. The data were reported byĀ Wijdan Rai, MD, from Ohio State University in aĀ poster titled ā€œComplications of Stem Cell…

#ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial

Full results of a Phase 2 clinical trial testing TG Therapeuticsā€™ lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

#ACTRIMS2019 ā€“ Jeffrey Cohen, MD, is New President of ACTRIMS

Jeffrey Cohen, MD, director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis Treatment and ResearchĀ at the Cleveland Clinic, is the newly named Ā president of ACTRIMS, the Americas Committee for Treatment and Research in Multiple Sclerosis. Cohen’s appointment concluded the 2019 ACTRIMS ForumĀ that ran…

#ACTRIMS2019 – Leukocyte Telomere Length Shortening is Predictive of Disability Progression in MS, Study Shows

As the protective molecular caps of our genetic information ā€” called telomeres ā€” become shorter in certain immune cells, the extent of multiple sclerosisĀ (MS) disability progression increases, regardless of age, researchers at theĀ University of California, San FranciscoĀ (UCSF) reported. The findings were presented at the annual…

#ACTRIMS2019 – No Evidence of Disease Activity Seen in POMS Adolescents Taking Rituximab, Small Study Shows

Data supporting the off-label use of rituximab in adolescents with pediatric-onset multiple sclerosis (POMS) was presented atĀ the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2019. The session, titledĀ ā€œNo Evidence of Disease Activity in the Majority of Pediatric-Onset Multiple Sclerosis Patients Receiving Rituximab,ā€…

Axim Improves Delivery of Cannabinoids in Chewing Gums

Axim Biotechnologies announced that it has succeeded in microencapsulating cannabinoids (chemical compounds in cannabis) into the companyā€™s patented chewing gums, which are used to treat several disease symptoms, including pain and spasticity associated withĀ multiple sclerosis (MS). Since the active cannabinoids are degradable in the body, the company needed…

Switching from Tysabri to Aubagio Can Help Lower Relapse Risk in MS Patients, Phase 4 Trial Shows

Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment toĀ Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, ā€œReducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,ā€…

Aubagio, Tecfidera Show Comparable Effectiveness in Relapsing MS, Real-world Phase 4 Trial Finds

Aubagio (teriflunomide)Ā seems to be superior to Tecfidera (dimethyl fumarate)Ā in slowingĀ whole brain shrinkage in patients withĀ relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…

New Compounds Offer Significant Anti-inflammatory, Neuroprotective Benefits in MS Mouse Study

Two newly identified variants of the known pharmaceutical agent chloroindazole showed significant anti-inflammatory and neuroprotective benefits in a mouse model of multiple sclerosis, a new study shows. Multiple sclerosis is an autoimmune, demyelinating disease of the central nervous system with no known cause or cure. Patients with MS characteristically show loss of the myelin sheath, a protective coat in nerve cells that helps increase cell-to-cell signaling. Several studies have suggested that estrogens ā€” a type of hormone ā€” are beneficial to the functioning of the central nervous system, and help regulate the immune system. Thus, they are attractive candidates for the treatment of MS. However, despite their potential to treat MS, estrogen-based therapies can have several undesirable side effects, such as feminizing male recipients and increasing the risk of developing breast and endometrial cancers in females. Interestingly, estrogens work by binding and activating two different types of receptors: the estrogen receptor (ER)Ī± and ERĪ². The cancer-inducing effects of estrogens are mediated mainly through estrogen receptor ERĪ±. Hence, therapies that specifically target ERĪ² can bypass these deleterious effects. Chloroindazole (IndCl), a pharmaceutical agent, has up to 100-fold relative binding affinity for ERĪ² over ERĪ±. IndCl has been shown previously to have beneficial effects on modulating the immune system and the central nervous system, and inducing myelination of nerve cells in mouse models of MS. Furthermore, IndCl and other ERĪ²-activating agents directly support the growth, differentiation (maturation), and overall myelination activity of oligodendrocytes, which are the nerve cells that produce the myelin sheath. Therefore, in order to optimize the benefits of IndCl, researchers developed and screened seven novel IndCl analogues for their ability to promote oligodendrocyte survival, growth, and differentiation. These analogues have a molecular structure closely similar to that of IndCl, but interact with estrogen receptors in subtly different ways. Among these seven compounds, researchers found two analogues ā€” IndCl-o-chloro and IndCl-o-methyl ā€” that stimulated growth and differentiation similar to the original IndCl. Next, researchers evaluated the benefits of these compounds in a mouse model of MS ā€” the experimental autoimmune encephalomyelitis (EAE) mouse model ā€” to determine whether they could alter the disease course, white matter pathology (level of demyelination), and inflammation. Results indicated that both compounds ā€œameliorated disease severity, increased mature OLs [oligodendrocytes], and improved overall myelination in the corpus callosum and white matter tracts of the spinal cord,ā€ researchers wrote. Corpus callosum is a thick band of nerves that connect the left and right side of the brain. White matter tracts connect the cortex (the largest part of the brain) with other areas in the central nervous system. These beneficial effects were accompanied by a reduced production of the toxic, inflammatory molecules interferon-Ī³ and CXCL10. Additionally, IndCl-o-methyl also reduced the levels of peripheral interleukin (IL)-17, a molecule that strongly induces inflammation. Furthermore, IndCl and both analogues upregulated the expression of a compound called CXCL1, which is associated with increased production of oligodendrocytes. Not only were these two newly identified compounds equivalent to IndCl, but the two analogues performed better in reducing disability and encouraging remyelination than the original compound, and without any obvious side effects. ā€œTheĀ o-Methyl andĀ o-Chloro IndCl analogues represent a class of ERĪ² ligands that offer significant remyelination and neuroprotection, as well as modulation of the immune system; hence, they appear appropriate to consider further for therapeutic development in multiple sclerosis and other demyelinating diseases,ā€ the researchers concluded. ā€œWe believe we created a drug that does two things really well, modulating inflammation and allowing axon remyelination. No other drug on the market can do these two things simultaneously,ā€ Seema K. Tiwari-Woodruff, said in a press releaseĀ written by Stacy Kish. Tiwari-Woodruff is the study's lead author. ā€œThe most amazing part of the study is that these new analogues of a known estrogen modulator, chloroindazole, are superior in treating mouse model of multiple sclerosis,ā€ she added. The team has patented the analogues, and hopes to begin further pharmacological and toxicity studies soon.

FDA Warns Against Plasma Transfusions from Young Donors Being Used to Treat MS and Other Diseases

The U.S. Food and Drug Administration (FDA) has warned against the use of plasma transfusions from young donors toĀ alleviate or treat the symptoms ofĀ multiple sclerosisĀ or other diseases, noting such transfusionsĀ have no proven clinical benefitĀ and carry known health risks associated with their use. Plasma is the liquid component of blood, containing proteins that help in clotting, and can be used to treat bleeding disorders and cases of trauma. But its use inĀ transfusions as a means of treating conditions ranging from multiple sclerosis, dementia, Alzheimerā€™s,Ā Parkinsonā€™s, heart disease and post-traumatic stress disorder are of concern, the FDA said in issuing itsĀ statement of Feb 19. "We have significant public health concerns about the promotion and use of plasma for these purposes," the FDA statement reads. "[W]eā€™re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing ā€¦ [necessary] to confirm the therapeutic benefit of a product and to ensure its safety." Scott Gottlieb, theĀ FDA's commissioner, and Peter Marks, director of its Center for Biologics Evaluation and Research, jointly issued the statement cautioning healthcare providers and the public that plasma infusions ā€” being done at "a growing number of clinics" in several U.S. states ā€” are not an FDA-approved or recognized treatment for aging, memory loss, multiple sclerosis, or other diseases. FDA-approved treatments largely come through clinical trials overseen by researchers and independent boards, and performed under anĀ investigational new drug (IND) applicationĀ that helps to ensure patient safety. ā€œOur concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised,ā€ theĀ statement notes. According to the FDA, large volumes of plasma might be also be needed for such transfusions and that volume can pose significant risks, including allergic reactions, infections, and heart and respiratory problems. The agency also expressed concern that such transfusions could discourage patients from taking medications or other treatments known to be safe and effective for their condition. According to the agency, some "establishments" across the country are recommendingĀ young donor plasma infusions and "touting" them "as cures and remedies," while sometimes "charging thousands of dollars." The FDA advises patients to consult with their treating physician before opting for any treatment to confirm that it is approved for use, meaning its safety and effectiveness have been demonstrated. ā€œSimply put, weā€™re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors,ā€ the FDA statement reads. It also asks that patients who have undergone a plasma transfusion report any ill effects to its MedWatch program, which tracks adverse events related to treatments.

Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports

Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, ā€œClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā€ was published in the journalĀ …

Vitamin B12, Folic Acid Supplements Yield Multiple Benefits for MS Patients

Vitamins B12 and B9 (folic acid) supplements can lower levels of homocysteine (a common amino acid), improve anemia status, and boost self-reported physical health in patients withĀ multiple sclerosis, according to new research. The study suggestsĀ a potential role for these two vitamins in improving the quality of life of MS patients. Despite treatment, MS patients often experience symptoms that interfere with their daily lives. Many patients have turned to dietary supplements with the hope they would reduce the severity of their symptoms. There is substantial literature suggesting the benefits of various supplements for MS, including vitamin B12 and folic acid. Homocysteine, of which high levels are associated with heart disease and detrimental effects in the nervous system, can be more prevalent in MS patients compared to healthy individuals. That suggests homocysteine is "one of the causative factors in the pathogenesis [development] of MS," researchers wrote. Lack of vitamin B12 ā€” naturally found in meat, fish, poultry, eggs, and dairy products ā€” can lead to a disruption in myelination, the process of forming a protective myelin coat around nerve cells. The loss of myelin is a hallmark of MS. A lack of folic acid, together with too little vitamin B12, has been linked to neurological symptom onset in MS patients. Meanwhile, vitamin B12 and folic acid supplements have shown promising results among these patients. In addition, MS patients are known to have an increased risk for the development of megaloblastic anemia ā€” a condition in which the bone marrow produces unusually large, immature red blood cells referred to as megaloblasts. TheĀ most common causes ofĀ megaloblastic anemia are a deficiency of either vitamin B12Ā or folic acid. Based on these observations,Ā researchers from Urmia University of Medical Sciences and Kermanshah University of Medical Sciences, in Iran, studied the effects ofĀ vitamin B12Ā and folic acid supplements inĀ Ā relapsing-remitting multiple sclerosis (RRMS)Ā patients. The team looked specifically at serum homocysteine levels, anemia status, and quality of life. This double-blinded clinical trial (IRCT2015100313678N7) enrolled 50 RRMS patients (age 20-40 years), who were divided into two groups:Ā the vitamin group, which received three doses of 1 mg vitamin B12 injection (spaced a month apart) plus 5 mg folic acid tablets daily; and theĀ placebo group, which receivedĀ neutral saline injections. All participants completed two quality-of-life questionnaires, one geared toward physical health and the other toward mental health, at the start and end of the study. Blood samples were collected from all participants, and blood pressure readings were taken. Results showed a drop in average homocysteine blood serum levels in the vitamin group, which may be indicative of an improvement in nervous system health.Ā Researchers also observed a decrease in mean corpuscular volume (MCV) in the vitamin group, which is indicative of improved anemia status. At the end of the study the vitamin group showed improvements in both physical and mental fields in the quality-of-life questionnaires. However, RRMS patients in the control group (without vitamin supplements) also had an increase in the quality-of-life questionnaire for mental health, obscuring any conclusions on the effect of vitamin supplements in MS patientsā€™ mental health. ā€œResults of the present study have shown that homocysteine levels, anemia status, and eventually the quality of life of patients with MS can be significantly improved by administration of 1 mg of vitamin B12 monthly and adding rich-food sources of folic acid on their diet,ā€ the researchers wrote. The team nonetheless emphasizes that "further studies in the field of MS dietary patterns must be conducted."