Category Archives: MS Treatment

TG Therapeuticsand the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab)to potentially treatrelapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the design and size of proposed protocols meant to ground a new drug application (NDA). The SPA marks the conditions under which the trial design adequately addresses objectives that, if met, will support consequent regulatory submission for approval of TG-1101. Stanford Universitys Dr. Lawrence Steinman will lead the program, which is expected to begin this year. Itincludes two Phase 3 clinical trials (ULTIMATE I and ULTIMATE II) both randomized, double-blind, active-controlled studies comparing TG-1101 to Aubagio (teriflunomide) in patients with relapsing MS. By targeting relapsing MS, TG-1101 could potentially be approved to two particular forms of the disease:relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS), which often follows RRMS. TG-1101 is TGs novel glyco-engineered monoclonal antibody that targets a specific and unique epitope on the CD20 proteinfound on mature B-cells. The primary endpoint of the trials will be changes inannualized relapse rate after 96 weeks of treatment in about 440 randomized patients in each … Continue reading →

Believe it or not, until 1993 there was no treatment available for multiple sclerosis (MS), with doctors turning to steroids to manage patients symptoms. But over the past several years, there's been an influx of new disease-modifying agents for MS, which affects more than two million people worldwide. "When MS therapeutics were new, there was a tendency to start with lower potency medications and escalate to a higher potency agent only if the patient with MS continued to worsen, Dr. Ellen Lathi, director of the Elliot Lewish Center in Wellesley, Mass., told Fox News. Now most MS specialists believe that it is best to start more potent medication earlier in the disease in many patients to avoid future disability. We know that once disability occurs, we can do little about it; it is best to treat as aggressively as needed to avoid this disability. Jud Ehrbar, of Manhattan, was diagnosed with relapsing-remitting MS nearly 20 years ago. At the time, the now-47-year-old was a drummer in a band, and had started teaching math in public school. He eventually sacrificed both as his symptoms worsened over the years. MICHIGAN BABY FACING LIFE-THREATENING DISEASE SIMILAR TO CHARLIE GARD'S DIAGNOSIS "Eating was a … Continue reading →

White House Press Secretary Sarah Huckabee Sanders (Screenshot of White House video) (CNSNews.com) - President Donald Trump is taking heat for comments he made last week that some believe seemed to endorse police brutality against members of the MS-13 gang and criminal cartels. During an event to highlight law enforcements efforts to combat the MS-13 gang in Long Island, N.Y., the president said Acting ICE Director Tom Homans guys are rough. And I can tell you, I saw some photos where Toms guys -- rough guys. They're rough. I don't want to be -- say it because theyll say that's not politically correct. You're not allowed to have rough people doing this kind of work, Trump said. Later in the speech, Trump said, Right now, we have less than 6,000 Enforcement and Removal Officers in ICE. This is not enough to protect a nation of more than 320 million people. It's essential that Congress fund another 10,000 ICE officers -- and we're asking for that -- so that we can eliminate MS-13 and root out the criminal cartels from our country. He went on to say, Now, we're getting them out anyway, but we'd like to get them out a … Continue reading →

Two different types of brain stimulation therapy are being tested to help relieve a number of MS-related symptoms such as leg spasticity and stress. Different types of brain stimulation are being tested, and also used, for the treatment of many multiple sclerosis symptoms. Two noninvasive brain stimulation procedures are showing potential and success in helping people with multiple sclerosis (MS) live better lives. One type is called Transcranial Magnetic Stimulation (TMS), and the other is called Transcranial Direct Current Stimulation (tDCS). These two brain stimulation methods are different, yet both are finding their ways into MS research. In TMS, a large machine is used to create a magnetic field that introduces electric current into of the brain. The procedure is performed in a clinic by a lab technician. Between the two therapies, TMS is considered stronger and can make electrons fire. tDCS is not as strong and only encourages electrons to fire. TMS has been tested on a variety of MS-related symptoms over the years. These include fatigue, mood and attention, chronic pain, and oxidative stress. TMS is also used for moderating the blood brain barrier, which has also been found to be of clinical significance in the treatment of … Continue reading →

What does your neurologist consider when he or she is deciding how best to treat your multiple sclerosis? A recent report from Spherix Global Insights, a business intelligence and market research company that looks at drug trends every quarter, sheds some light on that. In my last column I wrote about what that research revealed about the latest trends in disease-modifying drugs (DMDs): which treatments are hot and which are not. This column focuses on what that report has to say about how and why neurologists decide on the treatments they choose. Although the sample size is small, with only about 100 neurologists answering an online survey, it seems to do a good job of looking at this sort of thing. The neurologists surveyed are split on their treatment priorities. There was one goal that very few of the neurologists said they were interested in achieving. Only 2 percent thought it was important to stop the rate of their patients brain volume loss. That last bullet point, taking insurance coverage into consideration, appears to be becoming a much more common practice. A Spherix report from last April, DMT Switching in MS, says that in more than half the recent switches, … Continue reading →

In case you missedthem, here are some news stories that appeared in MS News Today that caught my eye over the past week: Those of us with MS know that if something can repair our myelin, the nerve insulator attacked by MS, theres a good chance some of our MS symptoms could be reversed. So this announcement, written by Magdalena Kegel, certainly lit my radar. Though this trial is limited to patients with a different disease, its certainly encouraging that this type of trial is moving ahead. A cell therapy intended to boostmyelin regeneration Q-Cells byQ Therapeuticshas received agreen light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that, likemultiple sclerosis, is characterized by myelin damage. FDA approval of the companys Investigational New Drug (IND) application allows researchers to start a Phase 1/2 clinical trial in whichnine patients will receive increasing doses of the treatment. **** Neither of the statements in this headline should surprise someone who has MS, particularly if that person frequents MS web sites and Facebook pages. As Magdalena Kegel reports, Ocrevus has stirred up a ton of interest among patients and doctors since … Continue reading →

Local woman trying experimental treatment to stop debilitating disease Monica Robins, WKYC 12:11 AM. EDT July 06, 2017 (Photo: Submitted by Chelsea Jennings) Chelsea Jennings uses yoga to stay centered. Its teaching keep her positive, which is important for for someone about to risk her live to save it. She's only 26 and facing a rapidly progressing debilitating disease that will likely put her in a wheelchair within a year. As a new mom, she won't accept that. That's why she's risking her life for an experimental treatment that could possibly cure her disease. Her motivation to try an experimental stem cell transplant to control her multiple sclerosis? Her 18-month-old son Camden and husband Jeff. "I understand that there is an extreme risk, but if the medication is not working for me I cannot just slowly deteriorate in front of my family, my son," Chelsea says. "I cannot have that happen." Diagnosed five years ago, Chelsea tried every MS medication available, but couldn't tolerate them. She researched alternatives and found Dr. Richard Burt at Northwestern University who performs hematopoietic stem cell transplantation for MS. Last month, she went in for testing and was approved. Unfortunately it's not covered by her … Continue reading →

Innate ImmunotherapeuticsMIS416has failed to helpsecondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups. Trial participants who received MIS416 had no meaningful improvements inneuromuscular function or the outcome of their disease, compared with those who took received a placebo. It is disappointing that these results dont show benefit for people with secondary progressive MS, for whom there are few treatment options, Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release. Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells,decreasing the inflammation and brain tissue damage associated with MS. Deterioration of the coating is a hallmark of the disease. The one-year trial (NCT02228213)tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week. There were no differences in the groups scores on a disability index the expanded disability status scale or in brain volume changes detected by magnetic … Continue reading →

Fitzgerald, Susan doi: 10.1097/01.NT.0000521713.03202.29 Features A new study found that minocycline may slow the progression of multiple sclerosis (MS) in patients who have early signs of the disease, but independent MS experts disagree about the efficacy of the treatment. Minocycline, an inexpensive decades-old antibiotic, may slow the progression of multiple sclerosis (MS) in patients who have early signs of the disease, according to a randomized, controlled trial reported in the June 1 issue of The New England Journal of Medicine. The study found that minocycline reduced the risk of conversion from a first demyelinating event, also known as clinically isolated syndrome (CIS), to a diagnosis of MS compared with placebo over six months. Minocycline, traditionally used to treat severe acne, has been shown in animal and laboratory studies to have anti-inflammatory and neuroprotective effects, and a few smaller human trials suggested it may have a place in MS treatment, either alone or in combination with other drugs. The results from this new trial conducted in Canada created a buzz in the MS community, but opinions vary on whether minocycline is poised to become part of the standard lineup of MS drugs. The study, funded by the Multiple Sclerosis Society of … Continue reading →

MS patients who start treatment at a younger age, and whose condition requires hospitalization, are more likely to stop treatment, a Canadian study reports. The research, published in the journal Dovepress,dealt with the main reasons Canadian patients quit first-line injected disease-modifying therapies, or DMTs. Itwas titledPersistence to disease-modifying therapies for multiple sclerosis in a Canadian cohort. DMTs can reduce MS activity, but patients must stick with them in order for them to be effective. There is currently a paucity of clinical trial data on what happens to individuals when they discontinue DMT, the researchers wrote. However, recent preliminary evidence from observational studies suggest increased relapses and disability in those who discontinue DMT. Researchers sought to identify MS patients at higher risk of discontinuing treatment. They looked at Manitoba Provinces medical database to identify the types of drugs MS patients were taking, and for how long. The analysis covered 721 patientswho received injected beta-interferons or Copaxonebetween 1996 and 2011, and whom doctors followed for at least a year. Tevamanufactures Copaxone, whose generic name isglatiramer acetate. The mean age of the patients in the study was37.6 years, and 74.2 percent were women. Researchers defined a discontinuation of a DMT as a 90-day … Continue reading →