MS News that Caught My Eye Last Week: Stem Cell Transplant, Cooling Therapy and Exercise, FDA OK for Generic Tecfidera, Top Stories of 2018
Stem Cell Transplant Lessens Disability and Relapses in RRMS Patients, Phase 2 Trial Shows
Here’s another study indicating that a stem cell transplant should be a treatment choice available to all MS patients where medically appropriate. Isn’t it past time to press harder on the stem cell treatment accelerator?
Treatment with autologous hematopoietic stem cell transplant led to a sustained decrease in disability and almost no clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows.
Trial findings were published in the study, “Prospective phase II clinical trial of autologous haematopoietic stem cell transplant for treatment refractory multiple sclerosis,” in the Journal of Neurology, Neurosurgery & Psychiatry.
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Cooling Therapy Before Exercise Can Increase Physical Activity in MS Patients
I like to exercise, and knowing that heat can kick up my MS symptoms, I sometimes use a cooling towel around my neck. But I never thought of cooling down before starting my workout routine. This review of several studies of pre-cooling suggests that it might be a good thing to do.
Lowering body temperature helps to improve exercise and functional capability in multiple sclerosis (MS) patients by preventing disease worsening, researchers in Greece report.
The study with that finding, “Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review,” was published in the journal Multiple Sclerosis And Related Disorders.
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Bafiertam, a Bioequivalent of Tecfidera, Receives Tentative OK from FDA for RRMS
Bioequivalent is a fancy way of saying generic. It’s a copy of a medication that’s required to have the same quality, safety, and strength as the original. So, the fact that the U.S. Food and Drug Administration (FDA) has given tentative approval to a generic for a very expensive MS disease-modifying treatment is exciting. But don’t hold your breath waiting for this. Final approval, if it comes, could still be 18 months away.
Banner Life Sciences has received tentative approval from the FDA for its new drug application for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogen’s Tecfidera (dimethyl fumarate) for the treatment of RRMS.
Final approval is expected no later than June 2020, the company announced.
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Top 10 Multiple Sclerosis Stories of 2018
The most-read MS stories on this website include information about a mouse study that showed potential for remyelination, updated data about Ocrevus (ocrelizumab), treatment with stem cells from umbilical cords, Epstein-Barr disease, and of course, medical marijuana. Check out this list in case you missed any.
Multiple Sclerosis News Today brought you daily coverage of key findings, treatment developments, and clinical trials related to multiple sclerosis (MS) throughout 2018.
We look forward to reporting more news to patients, family members, and caregivers dealing with MS during 2019.
Here are the top 10 most-read articles of 2018, with a brief description of what made them relevant for the MS community.
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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, Bionews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.
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Comments
Elizabeth Hall
Whenever your newsletter talks about stem cell transplants for MS it's usually about a study in Australia or another country besides the USA. Why not do a story about studies in the USA? Dr. Richard Burt is doing amazing things for MS in Chicago at Northwestern Memorial. My daughter just had a a stem cell transplant in December and she is happy she did! She is already noticing differences from her treatment and can't wait to improve even more!
Jason
Kudos! I wish your daughter my best. There are tons of places around the world that are doing this all ready. I was told that Dr. Burt wanted me to go on a drug first and they would see me in six months. I respectfully declined, headed overseas and haven't looked back. It's a shame what these companies are doing to Americans.
natania nunubiznez
tell me where, please- I want to pursue stem cells! even in a different country.
Jason
A.A. Maximov in Russia or Clinica Ruiz in Mexico are just a couple. It's called HSCT that you need. Couple that with sound approaches to your body (exercise, sleep, diet, etc...) and the difference is immeasurable. Good luck.
John Rush
A lot of the clinics overseas do not publish results in peer reviewed journals - and the various HSCT protocols can vary quite a bit (what they actually do to you). What are these centers commitment to helping you with comp,ications after you come back to your native country?
There are also various levels of success with who scientists believe will do well with stem cell transplants. A meta analysis published during 2017 in Neurology by Sormani et al, concludes: "the emerging evidence on this therapeutic approach in MS indiactes the largest benefit/risk profile from this therapeutic approach can be obtained in patients with aggressive MS with a relapsing remitting course who have not yet accumulated a high level of disability."
Here are some links:
https://www.nationalmssociety.org/Research/Research-News-Progress/Stem-Cells-in-MS/Bone-Marrow-Stem-Cell-Transplant-%E2%80%93-HSCT
I wish procedure was cure for MS but it is not. Data show that many experience a decrease in lesions - NEDA - no evidence of disease activity for some time but then disease process starts again.
HSCT is an aggressive therapy than has serious risks. These overseas clinics also charge tens of thousands of dollars.
I am an MS patient with progressive disease who has researched the disease for years. Go to pubmed.gov and type in searches related to any of above for good information/articles.
Also, I am familiar with tthe research at NW and Dr. Burt and have spoken to one of their nurses regarding their protocol; his team likely did you a service by suggesting one of the disease modifying therapies (DMTs) prior to considering HSCT. I do not know your case but likely the clinical presentation of your disease did not warrant immediate move to transplant.
Ed Tobias
Thanks for your very detailed and thoughtful comments, John.
You do a great job of providing some objective perspective to this treatment.
Ed
Jason
I hope you get this. First of all, you need to read Dr. Ruiz. You also need to stop reading the US press. The US is way behind the world. Dr. Burt is currently testing and trying to get something that he knows, and has known, that would pass. He's known of this for 15 years. The pharma companies are BAD. Why did Gilenya's price go from 63,000 in 2013 to 98,000 now? It's 2019 and you think they don't have a cure anywhere in world? If you think that, your a fool. It's two phase approach; do HSCT and get Mesenchymal. Again, the way the pharma companies go, you can't do that here - why? Because it's money.
John Rush
I read Dr. Ruiz - not much out there other than some Facebook posts for his clinic. He did post a recruiting notice for patients for a clinical trial here:
https://clinicaltrials.gov/ct2/show/NCT02674217
In the notice of suitable patients for the trial, he, himself, notes the mortality rates of HSCT as well fact that certain patients are more suitable for HSCT.
Also, you set up false dichotomy comparing costs of drugs from pharmacy firms to HSCT success. One does not follow from other: just because interferon costs are high, does not follow that HSCT is a cure. I do agree that the costs of the drugs are ridiculously high, but to say that Big Pharma is suppressing a cure as they are making too much money from MS patients, sounds like a conspiracy theory.
If Dr. Ruiz truly has a cure, wouldn't the world be beating a path to his door? If patients want to spend their money to pursue these overseas treatments that is of course their right but they should be aware of costs and risks.
As to, "stop reading the US press". I do not use the press for information - I read peer reviewed journals. The one I cited above happens to be in Neurology, which is published by a global company - Wolters Kluwer based out of Netherlands. I am not sure which country they print Neurology in. It doesn't matter to me - I look at the data regardless of country it is published out of.
I do not think there is a cure anywhere in the world, currently, and unfortunately. The data support this. Fool it is.
Jason
Depends on when you go. I was told I had MS and went right away and am fine; more than fine actually. Many people go when it's too late. It stinks that you waited for so long to find out about this - it really does. It's been around for over 15 years. It also really stinks that you can't find Dr. Ruiz's peer related work. Also, you didn't mention Dr. Burt and Dr. Fedorenko - why is that? It's not available in China? Really? There's a reason that you (and people like you) still have it; you're a cash cow. Lastly, you didn't address my question why Gilenya went from 63,000 to 98,000 a year (in 5 years no less). Why is that?
John Rush
I did mention Dr. Burt (last paragraph of my original post) - I mentioned I talked to his nurse. Here is latest talk by him that was just posted Jan 15 to YT, with latest MS results of his:
https://www.youtube.com/watch?v=5Qpw7XQWQgQ
I see no peer reviewed results for Dr. Ruiz, please share a link, I'll review. Same with Dr. Fedorenko.
As I did mention, HSCT it is not for everyone - that was my whole point. They are finding people with RRMS vs progressive to be the best candidates - ones that have failed a therapy and have active disease. Watch the latest research on attached.
Not available in China? I am not sure what you are referencing. I never mentioned China.
Not arguing MS drug prices are not ridiculously high - they are. Gilenya price still in about the 60K range per the YT link above. Not sure where your 9oK+ number comes from. HSCT at NW is about 120K I believe, per video, but of course this is one time only cost vs year over year cost w MS drugs.