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MN-166 (Ibudilast) Clinical Trial for Progressive MS

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    MN-166 (Ibudilast) Clinical Trial for Progressive MS

    Ibudilast
    From Wikipedia, the free encyclopedia
    Definition of Ibudilast


    Ibudilast (current development codes: AV-411 or MN-166) is an antiinflammatory drug used mainly in Japan, which acts as a phosphodiesterase inhibitor, inhibiting the PDE-4 subtype to the greatest extent,[1] but also showing significant inhibition of other PDE subtypes.[2][3]
    Ibudilast has bronchodilator, vasodilator [4] and neuroprotective effects,[5][6] and is mainly used in the treatment of asthma and stroke.[7] It inhibits platelet aggregation,[8] and may also be useful in the treatment of multiple sclerosis.[9]
    Ibudilast crosses the blood–brain barrier and suppresses glial cell activation. This activity has been shown to make ibudilast useful in the treatment of neuropathic pain and it not only enhances analgesia produced by opioid drugs, but also reduces the development of tolerance.[10]
    It may have some use reducing methamphetamine addiction.[11]

    Initiation of a cooperative phase 2b trial of MN-166 in progressive MS announced
    (19/07/13)
    MediciNova, Inc.announced the funding and regulatory approvals of a NIH-based grant for a Phase 2b trial of MN-166 (ibudilast) in subjects with progressive multiple sclerosis (progressive MS). The principal investigator will be Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic.

    The grant is for a funded cooperative effort by the NeuroNEXT clinical trial network within the National Institute of Neurological Disorders and Stroke (NINDS) at the U.S. National Institutes of Health (NIH). The collaboration additionally includes multiple academic centers, MediciNova and advocacy support from the National Multiple Sclerosis Society.

    "MS is the leading cause of non-traumatic neurologic disability in young adults and there are no approved therapies to alter the long-term course of this disease," noted Dr. Robert Fox, who has no financial relationship with MediciNova. He further added that "this will be a very important trial in the U.S. as we will have an opportunity to both evaluate the safety and efficacy of a potential neuroprotective therapy and to advance the development of clinical tools for studying neurodegenerative disorders."

    Dr. Fox became intrigued with the potential for MN-166 (ibudilast) as a peer-review expert of the summary data from MediciNova's Eastern European trial in relapsing multiple sclerosis wherein neuroprotective activity was indicated. He and MediciNova leaders recognized that ibudilast may be best positioned for utility as a new treatment for progressive multiple sclerosis (MS) and, together, began exploring a grant option with the NINDS' NeuroNEXT Phase 2 clinical trial network. Dr. Fox concluded that "we are very pleased to have successfully completed the requisite NIH and FDA review phases and look forward to initiating patient enrollment this fall."

    "There is a significant, unmet need for treatments that can benefit people with progressive forms of MS," says Timothy Coetzee, PhD, Chief Research Officer of the National MS Society. "This clinical trial of ibudilast will provide important information on a potential way to stop MS damage, as well as how to measure treatment benefits, and aligns well with the Society's research agenda for stopping MS progression."

    "We are pleased with the selection of MN-166 for this NeuroNEXT trial and the opportunity to advance its development in progressive MS.," said Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. "The safety and efficacy data derived from this trial will add to our overall development efforts and will complement efforts underway for Phase 2 trials of MN-166 in methamphetamine addiction and opioid addiction in the U.S."

    About the Trial

    The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 250 qualifying subjects will be randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of 100 mg/day (i.e. 50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization will be controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are: 1) to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) to evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/day) versus placebo administered orally in subjects with primary or secondary progressive multiple sclerosis.

    Secondary measures include imaging analyses of brain and retinal tissue integrity, cortical atrophy, disability, cognitive impairment, quality-of-life, and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses. The trial is expected to require approximately three years for enrollment, treatment, and data analyses.

    About the Cooperative Effort

    The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS's Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS' existing relationships with academic investigators and patient advocacy groups.

    A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at University of Iowa. Dr. Fox and colleagues at the Cleveland Clinic will collaborate with co-investigators at over 20 additional academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA Division of Neurology Products and additionally provides scientific and analytical support and drug and placebo supply.

    About MN-166 Clinical Development

    Clinical development of MN-166 (ibudilast) is ongoing in Phase 2 trials in three neurological areas - all via external funding. In the drug addiction arena, a National Institute of Drug Abuse (NIDA)-funded Phase 2a trial of MN-166 (ibudilast) in opioid dependence is ongoing with investigators at Columbia University and the New York State Psychiatric Institute and a NIDA-funded Phase 2b proof-of-concept trial in methamphetamine dependence is anticipated to initiate enrollment later this year with investigators at UCLA. An investigator-funded Phase 2a trial in chronic medication overuse headache pain is near completion at the University of Adelaide in Australia.

    "Our MN-166 development program is in a strong position to proceed on more than one commercial path with collaborating investigator expertise and generous funding and organizational support," said Dr. Iwaki. "We look forward to results of these important Phase 2 clinical trials" commented Dr. Iwaki.

    About MN-166 (ibudilast)

    MN-166 has been marketed in Japan and Korea since 1989 to treat cerebrovascular disorders, including post-stroke complications, and bronchial asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical for potential utility in MS. Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines including IL-1ß, TNF-a, and IL-6, and which upregulates the release of the anti-inflammatory cytokine IL-10 and neurotrophic factors such as NGF and GDNF.

    It attenuates the activation of brain glial cells in certain neurological conditions. Ibudilast's anti-neuroinflammatory and/or neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in progressive MS, drug addiction, and chronic neuropathic pain. MediciNova's development paths are firmly founded on issued method-of-use patents which, in the case for the treatment of Progressive MS, expires no earlier than 2029 in the U.S. A drug supply collaboration with Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has expanded to include development of higher dosage strength ibudilast capsules.

    Source: Market Watch Copyright © 2013 MarketWatch, Inc (19/07/13)

    #2
    I am signed up for this trial, and got my information in the mail yesterday. I will be at the Vanderbilt MS Clinic in Nashville, TN.
    Donna K: dx RRMS 12/07. Rebif 2/08 - 3/09, Tysabri 3/09 - 7/12, ended due to JCV+. Betasaron 8/12 - present
    Filed for SSDI 8/12. Approved 11/12
    dx PPMS 7/13. Added Metotrexate 2.5 mgx3 to Beteseron. Stopped all meds 3/14 to quality for ibudilast clinical trial for PPMS

    Comment


      #3
      Ibudilast looks promising. Best of luck to you Donna!

      Comment


        #4
        Good luck Donna!

        I'm so glad to hear of a promising trial for progressive patients. Please keep us updated.

        Comment


          #5
          I'm going to be in the study in NYS. Just waiting to get the paper work in the mail.

          Comment


            #6
            Does anyone know if ibudilast has severe side effects ? I have been trying to read all of the information about this drug and I haven't seen much about the side effects.

            Comment


              #7
              I'm in the trial

              Did all of my blood work, MRI, testing, etc. and I received word yesterday that I've been accepted into the trial. I am patient 243 or so out of 250.

              I go back Nov 20 to get the drug (or not).

              Comment


                #8
                Progess Report

                I've been on the drug almost 3 months with no side effects to speak of. It's a lot of pills, though. It's 10 pills daily, 5 in the morning with breakfast and 5 at night with dinner. Apparently, some people experience problems when taking the medication on an empty stomach.

                I have no idea if I received the drug or the placebo. Since the drug is being tested for helping to stop or slow progression, I don't expect to see a difference in my daily life. It's also way too early to know how my MS is progressing, which would give me inkling of whether I received the drug or not. Of course, that assumes that the drug actually does help stop/slow progression.

                Finaaly, I appear to have developed a UTI. I haven't felt any symptoms, but the last 2 tests showed an infection. Of course, like many people with MS, I have bladder issues. This infection might not have anything to do with the drug trial.

                Comment


                  #9
                  Thank you for sharing BJG55.

                  I hope you are on the drug and that your MS progression is halted. Please keep us updated with your progress.

                  Best wishes!

                  Comment


                    #10
                    best of luck with your UTI. I get them fairly often myself, but they never present any pain or any difficulties exceeding what I presently have.
                    Thank you for taking part in this trial. It is people like you that are willing to take a chance that keep the ball rolling forward.
                    hunterd/HuntOP/Dave
                    volunteer
                    MS World
                    hunterd@msworld.org
                    PPMS DX 2001

                    "ADAPT AND OVERCOME" - MY COUSIN

                    Comment


                      #11
                      If this drug is being investigated at Columbia Presbyterian Med, I think I was offered admission to the trial several months ago. I declined because I couldn't find a way to travel to NYC. I know how to get there, but I wouldn't be in any shape to do anything, due to the tremendous fatigue factor that I experience.
                      I wish all of the participants the best of luck with this trial. And, in about 6 years, my neurologist will tell me how 'promising' this 'treatment' is. I'm willing to be wrong. Prove me wrong.

                      Comment


                        #12
                        Just got the consent forms, and think I'm going to apply. It would be at Cleveland Clinic, so a bit of back and forth driving for me. I noticed that one of the secondary measures is neuropathic pain. Since that's my biggest baddest symptom, I'm really hoping that if I get in, and if I'm among the 50% who are getting the real stuff, that it will help with that.

                        I hope that your UTI is gone by now, BJG55. Good luck--please keep letting us know how you're doing.
                        PPMS
                        Dx 07/13

                        Comment


                          #13
                          Progress

                          FYI - My UTI is gone and I hope it stays that way. Also good news is that after several monthly visits, I now only have to make the 60+ mile (one-way) journey on a quarterly basis.

                          Comment


                            #14
                            Hope things are still looking up for you, BGJ. I'm still waiting here. Apparently, my hometown health system has been sitting on my records for quite some time, but the Cleveland Clinic woman finally called them, and said that maybe I'll hear some time next week.
                            PPMS
                            Dx 07/13

                            Comment


                              #15
                              Ready to scream at someone--my healthcare system still hasn't sent my records to Cleveland Clinic! They did this with my MRIs and lumbar puncture results when I was trying to get diagnosed. They practically had me in tears, beginning them over and over again to please get them in the mail. They are beyond neglectful...they are evil.
                              PPMS
                              Dx 07/13

                              Comment

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