#ACTRIMS2018 – Clene Nanomedicine Presents Positive Results for MS Remyelinating Therapy
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Clene Nanomedicine says its pre-clinical studies demonstrate the remyelination effects of CNM-Au8, supporting its potential to treat multiple sclerosis (MS) and other demyelinating disorders.
Clene presented its data in a session, “Nanocrystalline Gold As a Novel Remyelination Therapeutic for Multiple Sclerosis,” that took place at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in, held Feb. 13 in San Diego.
In MS, demyelination — the loss of the myelin sheaths surrounding neurons — is accompanied by a disturbance in the ability of nerve cells to conduct signals to and from the brain.
CNM-Au8 is an orally administered gold nanocrystal suspension that triggers oligodendrocyte cells to produce new myelin. Oligodendrocyte precursor cells are present in adult brains and have been detected in and around MS lesions. Yet they must be activated into mature oligodendrocytes in order to produce new myelin. CNM-Au8 induces the activation and differentiation of oligodendrocyte precursor cells.
CNM-Au8 has been shown to induce remyelination in multiple animal models of MS. Researchers demyelinated these animal models either by feeding them cuprizone, a toxin, to demyelinate neurons in the central nervous system, or injecting them with lysolecithin to demyelinate spinal nerve axons.
In the lysolecithin model, through the use of Luxol fast blue (LFB) staining, CNM-Au8 was found to induce remyelination. Researchers commonly use LFB to observe myelin under a microscope. Furthermore, behavioral and fine motor assays in cuprizone-treated mice showed that CNM-Au8 restored behavioral function following demyelination.
The results also suggested that CNM-Au8 enhances cellular bioenergetic processes, which most likely helps increase myelination.
One of the major drawbacks to therapies now used to treat MS is that they don’t work to remyelinate MS lesions.
“Remyelination of MS lesions represents an important unmet clinical need unaddressed by current therapies,” Mark S. Freedman, neurology professor at Canada’s University of Ottawa, said in a press release. “Clene’s preclinical remyelination data are very encouraging, and the proposed mechanism of action of enhanced bioenergetics driving cellular differentiation and myelin production is unique and represents a paradigm shift in MS therapeutics.”
Added Clene’s CEO, Rob Etherington: “The therapeutic potential of CNM-Au8 for helping patients with demyelinating disorders is significant. No other drugs approved for the treatment of MS have been shown to remyelinate chronic MS-induced lesions. For this reason, we are looking forward to the launch of our VISIONARY-MS Phase 2 trial in the summer of 2018 with oral administration of CNM-Au8 in adults with relapsing remitting multiple sclerosis who suffer from chronic optic neuropathy.”
Clene, which is headquartered in Salt Lake City, Utah, collaborated with Stephen D. Miller of Northwestern University and Robert H. Miller of George Washington University in these pre-clinical studies.
Bob Parham
I would like to be apart of the phase 2 trials. I'm a patient with primary MS for Over 18 years.
Peggy
How do I find out more about your phase 2 trial. I have SPMS.
Thank you.
Flake28
Hi Bob and Peggy.
Sorry to say you both may not be eligible:
The study is focused on participants with RRMS < 10 years and significant optic nerve damage as a result.
Please see ClincalTrial NCT03536559, which specifies this criteria.
Hang in there, Its a great time for MS research and hopefully there'll be a strong remyelinating product available in the next 5 years.
Martin Knudsen
Best news for my wife and I ever!
melvin spears
awesome !! great news !! where does one sign up to be considered to be a part of the planned upcoming clinical trial ? i would very much like to be considered for the clinical trial if possible.
thank you
Melvin Spears
Jan Gear
I would like to get info on the trial coming up. Thank you
Kevin Estrem
My wife has primary progressive MS but has had no active lesions for her last 5 MRIs making her ineligible for some other new therapies that have come out in the last 12 months. She's immobile from her stomach to her toes (still has feeling, just no motor function.
She is 63 years old and was diagnosed in May 2010. Would she be a candidate to try this new oral therapy?
John Bell
Dear Kevin
From the description you gave about your wife's
PPMS , it sounds as if she would be a prime candidate for
MD1003 or (Biotin) My wife Sandra is taking it and we are
sure that she has stopped getting any worse !
Read up on biotin for progressive MS and good
luck to you both
Regards. John
Douglas Fisher
I want to try md1003 biotin. I can't find it in the states. Would like to hear more about availability. Send me an email at [email protected]. thank you
LAURIE
I'm hoping this will work on all types of MS. We need to
find better ways to treat this disease. Especially for those of us who have tried anything and everything but have only gotten worse.
JOYCE CERVENKA
I hope I live long enough to see this happen.
Christopher
This earth moving break threw is a positron introduced bye a computer sequence transferred and processed bye a scientific reversal, as in the MATRIX.... Blessings to the master Creator for Codes>>>><<<<<<<< <<<<<<Beautiful Code Breakers<<<<<<
Larry
Exciting news. Would like to learn more about participating in trials, and help accelerate the approval process.
Merichel
Great news! Hope they can make this work as a treatment for humans without severe side effects. If it's safe this would be the best thing ever discovered for us.
Marla Couch
I would like to take part in this clinical trial. I have relapse remitting MS. How do I sign up for this? I was diagnosed in April 2010.
Thank you.
Bart Dek
Could this lead to a treatment for Primary Progressive MS patients as well?
Dave
Unfortunately, by the time most of us folks inflicted Ms can benefit, it will not matter...but thanks for trying. So much for Trump trying to fast track things through the U.S. pharmaceutical system. Oh well. Big pharmaceutical is much thicker than any border wall we will ever have? Well folks keep yer heads up. Godspeed To your health.?
Dale
hi
Would like to sign up my brother who has MS for 5 years now and is degenerating quickly. Any person that you could recommend that we could contact?
Shirley A. Nobbs
I would like to take part in the study as well. I have primary progressive MS.
Eamonn Cullen
I suffer with AMN and these early trials suggest that this drug maybe beneficial for my condition. I would very much appreciate the opportunity to try this new drug.
Regards
Eamonn
Shiwanshu Shiwam
I have diagnosed for MS in December 2017. The first attack was the weakness in right hand and right leg. This affected my motor function and now I cannot write properly as before.
As per Doctor, There is no cure and I have to live with this and wait for next attack which can be anything as per MS symptoms. Please advise if any treatment is there to slow the progress.
Shelby
Get a new doctor. There are many drug therapies to slow the progression. I take tecfidera. I haven’t had a relapse since being diagnosed in 2015. Good luck, and take care of yourself. Don’t give up.
Jennifer Aumuller
I have RRMS for 11 years. Would love to be a part of the clinical trial.
Stacie Zeller
Sign me up. I am a 45 year old Caucasian woman. I've had MS for 20 years. The last year-and-a-half MS has tried to Define who I am but it's Mind Over Matter. I will win. Currently not on any medication. Prior medications started with Copaxone ended with Tecfidera. Would love more information on this study
Coleen
I would like to take part since I have failed 7 meds and 25 times in the hospital. I'm am totally interested! Help!
Karen hutter
I too would be interested in this trial study. I have been diagnosed with relapsing remitting MS since Aug 2010.
Kerry Ĺewis
Where do people sign up,and how long will it take to get approval from fda!
M.Palmer
Sounds so amazing. Would love to be part of the trial. We NEED this drug to come to fruition.
Victor
I am a 47 yr old male with RRMS diagnosed in 2012,still mobile but worsening, I am interested in taking part in your trial.
Charla Chapman
Very interested in participating in the phase 2 trial
Eugene Banjs
I know God has a plan that will work out for everybody
Gordon
S there any way this med can be purchased. Maybe under another label. Without lousy cheats trying to scam us
Warrior
"For this reason, we are looking forward to the launch of our VISIONARY-MS Phase 2 trial in the summer of 2018 with oral administration of CNM-Au8 in adults with relapsing remitting multiple sclerosis who suffer from chronic optic neuropathy.”
Angela Batzel
Very interested in participating in next phase.
Craig M. Bryda
Diagnosed in July 2017
At 69 years old, shocked at that news but in thinking back I remember things changing mobility wise back to 2000. I presently have no use of my legs. Haven't (cannot) walk or stand.Any kind of relief of this crippling disease would be welcome. I would definately be very interested in taking part in any tests & studies. Sign me up. Thank you.
Julie
I would like to take part in the trial if available. I have had RRMS since 2010 and have tried 4 different medications. Now on Ocrevus. I have had many relapses. I would love to see if my myelin can be reversed. You can contact me anytime at my email address. Thank You
jane stone
have primary provressive ms which has stablized with ocrevas. please include me in trial.
Janet garcia
I would also like to be a participant for this trial study,
Karren
My 33 yr old son was diagnosed in 2010 & is very interested in participating in this study.
Chas
I wAnt to be in study too!
Tanith Marais
Diagnosed in 2000 with RRMS, currently 39 female from South Africa. How long would it take to get here?
Betty Jane Easley
I was diagnosed in 2004, but of course had it much longer. I’m 61 years and I’m very interested in the study! I would very much appreciate being considered! Thank you!
Lyn Heaton
Have RRMS and on Ocrevus and seem to be getting worse, not working! I'd love to try this theraphy.
James Farrar
I would like to try. I was diagnosed 4 years ago, and ive been in a wheelchair over 2 1/2 years. Im a jiu-jitsu black belt, with a 4 year old son. Ive been on ocrevus, and am going for my 2nd infusion. I need help please.
Douglas Domonoske
Would love to be part of this trial was diagnosed with MS three years ago
Theresa riess
I would love to be in the trial. I have rrms and chronic optic neuritis going on 2 years. Please contact me!!
Penny Nairn
My Son suffers from progressive MS where can he sign up for these trials ???
Rick Davis
This is awesome news, my wife would have loved to hear this news, she was diagnosed in 09 with relapse remitting, wich quickly went to primary progressive, in 2017 got brain cancer and has passed away, someone please help these people
Michelle
Where do I sign up? I would love to hear more!
Flake28
Hi everyone!
Many of you are affected by SPMS or PPMS. I am sorry to say the eligibility for NCT03536559 is quite restricted as it is a very early phase 2 study - it has barely been tested in humans yet at all.
1) At least 18 years of age and up to 50 years of age (inclusive).
2) Clinical diagnosis of MS (meeting McDonald criteria, 2010) who have had RRMS no longer than 10 years from diagnosis.
3) Presence of chronic optic neuropathy defined by clinical and/or multifocal visual evoked potential (mf-VEP) criteria.
4) Retinal Nerve Fiber Layer (RNFL) thickness > 70 μm.
5) Stable disease activity based on the Investigator's judgment over the prior 12 months.
6) Able to understand and give written informed consent.
Criteria 2,3,4 and 5 are going to limit many applicants. Hang in there - We'll get the answers we need in the early study and if this works out well, we can progress to phase 3 and phase 4 studies. This is how we got Ocrevus approved recently, and if CMN-Au8 works in humans than this will be the same route.