Potential Progressive MS Treatment, Ibudilast, Approved for Fast Track Development by FDA

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Potential progressive MS treatment

MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease.

MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential in treating relapsing-remitting MS (RRMS). MN-166 is a first-in-class, orally bioavailable, small-molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that works by suppressing pro-inflammatory cytokines and promoting neurotrophic factors. It reduces activated glia cells, which play a significant role in a number of neurological conditions.

Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, that were the basis for investigating its therapeutic utility in neurodegenerative diseases like progressive MS and amyotrophic lateral sclerosis, and in substance abuse and chronic neuropathic pain.

“We are very pleased that MN-166 has received Fast Track Designation for progressive MS and believe this validates its potential to address unmet medical needs for this serious disease. We look forward to providing further updates from our ongoing clinical trial in progressive MS,” Yuichi Iwaki, MD, PhD, MediciNova’s president and chief executive officer, said in a press release.

In MS, an abnormal immune response turns against the patient’s own central nervous system (CNS), including the brain, spinal cord, and optic nerves. The immune system attacks nerve fibers and myelin, a fatty substance that encircles and protects nerve fibers. Damage to myelin and nerve fibers can interrupt nerve impulses between the brain and spinal cord, leading lead to a variety of symptoms that include spasticity, numbness, walking difficulties, fatigue, depression, and cognitive and emotional changes.

Nearly 85 percent of all MS patients are diagnosed with RRMS, characterized by inflammatory attacks on myelin and a series of new or progressing neurologic symptoms. These patients, over time, transition to SPMS, marked by a progressive worsening of neurological function and disability, but few to no relapses. About 10 percent of MS patients are initially diagnosed with PPMS, characterized by a worsening of neurological function from its onset.

Current MS therapies address the inflammatory response in RRMS, but are of limited or no benefit regarding neurodegeneration or brain tissue repair.

The FDA’s Fast Track designation is awarded to speed the development and review of drugs with the potential to address unmet medical needs in serious or life-threatening diseases.

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  1. Shasha says:

    The MS attacks are due to gluten/dairy/soy/sugar/GMO…Low oxygen in the brain due to low Vit B12/low thyroid/low Vit D3 etc..no need for this fast tracked drug. The American die hurts people’s brain/body. Eating organic and no gluten/hidden gluten/GMO/sugar/soy/dairy may help them heal fast. LDN may help block hidden gluten which maybe in the air. Eating no food in a box/bag/label may help. Just eating pure foods/getting sunlight/exercise/good water/low stress/detox/clean up infections etc may help MS.

      • Shasha says:

        I have MS and suppress it this way. MS people can heal and I watched my friend heal fast and is dating/driving again/went sky diving/rides on the back of a motor cycle/now has 2 jobs compared to being slumped over in a wheel chair. MS people can heal. You have free. If you want a drug that is your choice. LDN $1 helps me. People have choices. You have free will lto pick want you want. People need to know there is another choice…natural which has healed MS/cancer etc fast. Alternative doctors/chiropractors etc may help if people make an effort. Best wishes.

        • Cindy says:

          LDN is not the answer. I was on it for MS when I was still able to walk and I still got progressively worse. I’m in a wheelchair now. I gave up on LDN a few years ago.
          I’m hopeful that something will come along that will restore some of what I’ve lost.

    • George Duncan says:

      Proper diet and exercise will help with any chronic illness. I have changed my diet, exercise regime, quit smoking etc. Along with a disease modifying therapy and meds that ease brain inflammation, I believe the course of my disease has been altered. I am right there with you by not polluting my body, but there is strong clinical evidence that shows this drug may help. If it does I hope you may benefit from it as well.

  2. Suzanne Branch says:

    Shasha, that’s called remission. I had an optical problem. I took prednisone for six weeks. I didn’t have a relapse for 17 years. I ate bread, processed food, you name. This is m s. No one has figured out its path or how to control. For the past 16 years, I’ve tried everything . Who knows if anything helped. I’m in a wheelchair now. 33 years later.

    • Lynda Strecker says:

      Suzanne, I agree that what Shasha was describing could be remission. My 1st attack which was not diagnosed @ the time it occurred was @ age 37. With the exception of minor tingling in my feet and slight numbness in my R. leg, I was fine until I was age 52. In 1993,15 yrs. later, more symptoms began to appear, mainly,my dragging (slightly) of the R. leg and foot drop of same leg. These symptoms were brought on by a stressful emotional period of my life. An MRI showed no signs of MS so a spinal tap was done and the main thing that that indicated was an elevated IGG level. Bladder problems began then also and some weakness in my R. hand. That was a bummer because I was a pianist and taught music in the public schools for nearly 30 yrs. My ability to play w/ my R. hand deteriorated slowly and I was able to teach for 5 more yrs.They talk @ lack of Vitamin D but i was at the beach more than anyone in my family. I WAS/am a sun worshipper for sure and always had a deep tan w/little effort. My sisters were much less exposed to the sun but, I am the one w/MS.
      I do believe however, that diet plays a huge role. I gave up gluten and had great relief from IBS. I saw a nutritionist who put me on a path w/ many of the supplements mentioned above. I rarely eat animal fats, red meat or dairy and cut back on sugar. I have managed to keep it at bay until last yr. when I got the flu and had to be hospitalized.When i came home after @ a wk., I was weak but improving daily until I fell and fracture my R. leg in 10 places. I had to go to rehab for @ 6 wks. and I was in a cast from toes to mid thigh! That event was the worst thing for the MS as I lost alot in terms of mobility. I’m working hard to get back to where I was. The PT I received was spotty and it’s been 3 mos. w/out PT. Like you, I’ve tried everything including bee stings.
      I too am in a powerchair and have also considered trying LDN.
      My cynical view is that “they” do not want to cure any disease as the “Big Pharma” industry would be financially impacted in a huge way. Some MS patients have had great results from various stem cell therapies but w/ price tags of 100,00 dollars and no ins. coverage. Scientists were saying that embryonic stem cells would be extremely effective in healing MS. That was 20 yrs. ago or more. George Bush signed some law prohibiting the use of embryonic stem cells because of the religious objections fron Conservatives. I keep hoping as we all do for a breakthrough or cure but as long as these drug cos. are making billions in profit from the MS drugs (not to mention all the other diseases they claim to help), cures will not be forthcoming:-( A Dr. friend of mine who also has MS, lives in Sweeden and mentioned a seminar she attended some yrs. ago at which the presenter wrote the following statement on the board at the beginning of the meeting. “CURES DO NOT = PROFITS.” That says it all, sadly. There must be a solution which would mean getting huge profits out of this industry. I did not intend to write this lengthy comment but I feel so strongly that patients who suffer from all major illnesses are being held hostage by the pharmaceutical industry. 1959 was the last time a major illness, (polio)was cured. That was Dr. Jonas Salk w/his vaccine. Thank God for him. There needs to be a revolution in this area of medical science.

  3. Sadie says:

    LDN was awful. Used it for over a year and it caused all sorts of problems. Some never resolved! Everyone responds differently to meds alternative or not. Everyone is different so when you try something that doesn’t work you must move on to something. There definately is a need to fast track drugs. People with MS such as myself are getting desperate to try anything! Have had MS for over 20 years.

  4. Scott says:

    “I will stand”

    “It’s OK,
    it’s all right,
    that I’m not strong for this fight.
    It does not matter what I am,
    for in my weakness
    grace shall spand
    I’ve been loved since time began
    So goes my soul
    if I’m worth that plan Not on mine but on His I’ll stand
    So goes my soul
    if says I AM”

    • Lois says:

      Over and over we’ve all grid the purported cure
      Progressive is as progressive does
      I’m All for natural but not being able to walk SUCKsssss
      Just have some compassion and understand all those afflicted with MS just want it gone
      By any means,,,,,,

      • Lynda Strecker says:

        AMEN to that, Lois! I cringe when I hear or read comments which state that this disease is a blessing. Sorry, but the words,” to bless”, mean ,to make happy. I have as much faith as anyone but this disease is not a blessing. I had a health aide who was pretty mean tell me that God was punishing me for something I must have done in the past. I am 74. I, of course, requested she be replaced.

  5. Amit says:

    It is a real pity that when, every single MS patient ultimately transitions from RRMS to Progressive MS, there exists not a single proven effective treatment option for Progressive MS.It just shows the collective ignorance/disdain of the society to the needs of progressive MSers.

    • Shasha says:

      I have MS…suppress it..not get worse. Celiac may get worse with age and drugs may not help Celiac except LDN which helps to block hidden gluten. Celiac may cause MS. Tests may not work to diagnose Celiac. Alternative doctors/chiropractors etc help rebuild the brain/body…restore health. To me drugs let MS get worse since they are not treating the root cause. Best wishes.

    • Shasha says:

      I agree as MS gets worse the doctor may not be as friendly. My Neurologist stopped shaking my hand when I got worse due to heavy metals which I needed to detox. He did not figure out heavy metals were hurting me and did not know how to detox me so I had to leave Conventional medicine and go to Alternative medicine to get the help I needed. I needed EDTA/DMPS IV chelations which saved my life. The Alternative people welcomed me with love/caring/awesome help and were cheap. I had more than one hour visits for cheap and they really listened/knew how to help/heal me. Ask at a health food store for the name of a good Alternative doctor or chiropractor that may help you fast. Best wishes.

  6. Steve Johns says:

    What annoys me is that drug companies have gone through the approval process for many of these treatments for RRMS But excluded PPMS/SPMS so they can wait a few years then do the trials for progressive forms. This lets them claim a new application and so extend their patents by many years and allows them to continue to charge extortionist prices for them. We desperately need reform.

    • Shasha says:

      Yes..they keep the patent by also changing the name of the drug and changing a minor thing in it maybe like water etc. People think it is a new drug, but is the old drug recycled and minor changes only added that don’t make a difference. I have not seen MS drugs help my friends much. A few MS people told me they don’t want to change their diet. Gluten can be like Heroin to the brain and sugar like cocaine so people may not want to give these foods up. Gluten/dairy/soy/sugar/GMO hurt me. I eat now low sugar fruit, but sugar swells my brain and slows mitchondria. Just changing the diet may help greatly. I also take LDN which blocks hidden gluten since it is hard to avoid the hidden gluten. They want each MS drug to cost about $5000 a month. What I do is much cheaper. It takes effort, but is worth it. Best wishes.

      • Angela O'Keeffe says:

        Each to their own Sasha. MS is different in everyone and so much is unknown that it is never possible to truly say that any treatment “works” or not. I live in Australia and have been on Tysabri (Nataluzimab) for 5 years. All I am sure of is that my rate of relapses has reduced dramatically and I have the promise the drug company carefully gave me. It has slowed progression of my disease. I can honestly say that among the pwMS that I know, none are that silly that they think just a drug is the answer. Lifestyle and diet etc are also important. However I know quite a few with progressive disease who would be so grateful to have something to give them hope that they have more time before it is too late for them. I hope this drug is approved very soon by the FDA because we in Australia will be waiting a whole lot longer for it. I hope you remain symptom free forever but I am not going to be taking chances. Bring it on.

  7. JudithIt's indescribably important that we know what is in our food. Epstein says:

    Being it on. I’ve done the all natural route since I was dgnsd in 1990 with rrms due to high solvent exposure (Google Dr. David Wheldon for solvent info). Not everyone is effected by this. Now I’m 5 years past menopause and spms has kicked in slowly. I take homeopathics and don’t know if Ibudilast will be good to use…

    • Shasha says:

      Yes..Natural help for MS may work fast to help MS people. Celiac diet..no gluten/dairy/soy/sugar/GMO..vitamins/good oils/minerals…probiotic…LDN..detoxing etc may help MS and brain/body health issues. Progesterone stops at menopause. Taking estriol/progesterone/testosterone may help restore circulation/lower swelling and inflammation and help bones/brain/body fast. Alternative doctors may help restore brain/body with diet/supplements/detoxing etc. MS is scary/not fun, but people can heal. There is hope/help with Alternative medicine.

  8. Suzanne says:

    In my humble opinion, m s sucks. It sucks my energy as I try to pull my underwear and pants up. It sucks joy out because I know that I can’t drink more than one glass of water when I’m out because there isn’t an accessible toilet. It sucks hope out because most new treatments don’t even pretend to restore function. It is scary, even for the brave because the demyelination occurs every day.
    If changing your diet, controlling your breathing, and thinking happy thoughts works for you, even for an hour, that is a blessing.

    • Christa says:

      That sounds exacting like me. But taking in enough fluids for fear of an accident because I couldn’t make it to the bathroom. What you’re I’d ms do you have, and what do you for yours?

    • Suzanne says:

      Whatever keeps you going. In my opinion , and I have no expertise, everyone with this disease is lucky. Some have better luck, others have bad luck. Drugs, diet exercise, spirituality are all distractions. What we all pray for is better luck and a cure.

  9. Wulf says:

    I just read an article that suggested a 3 day fast then 4 regular days of eating regularly. I was interested in it because the article explained why they thought it worked.
    I don’t have MS, I have the long lost cousin, Charcot Marie Tooth, which also affects the nervous system. I’m dealing with a lot of pain at this time. As always, please use your sound judgement when looking at articles like these.

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