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Thread: Remylinating development.....not sure of the dates on this research.....rHIgM22

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    Distinguished Community Member Lazarus's Avatar
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    Default Remylinating development.....not sure of the dates on this research.....rHIgM22

    Remyelinating Monoclonal Antibody For Treatment of MS

    rHIgM22 is a remyelinating antibody being studied for the potential treatment of multiple sclerosis (MS). Acorda is currently conducting a Phase 1 clinical trial to assess the safety and tolerability of a single dose of rHIgM22 in people with MS. The study also includes several exploratory efficacy measures.

    MS is a chronic, usually progressive disease in which a personís own immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin (a process known as demyelination) and eventually the nerve fibers themselves. Myelin is a fatty layer of membranes that insulates nerves, facilitating the transmission of electrical impulses through nerve pathways that control neurological function.

    The cells that make myelin, called oligodendrocytes, can initially repair myelin, but as MS progresses, there is little spontaneous repair. Currently, there are no therapies that stimulate the repair or regrowth of myelin once it has been damaged in demyelinating diseases such as MS. If myelin is able to be repaired, it could restore electrical conduction and may serve to protect the exposed nerve fiber from further damage.

    Preclinical studies have found that rHIgM22 promoted remyelination by stimulating oligodendrocytes to repair areas of demyelination. Preclinical studies with rHIgM22 also resulted in sustained improvements in motor activity.

    Acorda and the Mayo Foundation for Medical Education and Research have been collaborating on the remyelinating antibody program since 1995.
    Linda~~~~

    Be the kind of woman that when your feet hit the floor each morning the devil says:"Oh Crap, She's up!"

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    Distinguished Community Member SalpalSally's Avatar
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    Thanks Linda, Sounds good,
    But, it took them 20 years of research to come up with a phase 1 trial.
    Good Lord, I wonder how long it will take to be approved by FDA????
    I'm not gonna hold my breath!!
    Love, Sally


    "The best way out is always through". Robert Frost







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    Distinguished Community Member agate's Avatar
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    Thanks for posting this, Linda. It's a small study and has a way to go but it could turn out to be important. And Mayo Clinic is behind it.

    Seems the FIH (first-in-human) study is currently going forward and will end this September (2014). The drug might be effective for progressive forms of MS.

    This is the most recent information I could find (excerpted from Healthline News, September 2013):

    Trial of New Drug Therapy Seeks to Repair Nerves Damaged by MS

    Written by Jeri Burtchell
    Published on September 18, 2013

    If successful, a new remyelinating antibody called rHIgM22 may help reverse nerve damage caused by MS.

    In a collaboration between the Mayo Clinic and Acorda Therapeutics, Inc., a “first-in-human” trial of the drug rHIgM22 to repair nerve damage caused by multiple sclerosis (MS) is currently [in progress].

    Earlier animal studies of rHIgM22 showed improvements in motor activity, meaning a possible reversal of disability. If successful, this could be a groundbreaking achievement, particularly for those with progressive forms of MS, for which there are no treatments currently available.


    How the Drug Works

    ...
    People with MS experience symptoms that, depending on the size, location, and number of plaques in their brain or spinal cord, can range from numbness and tingling to complete paralysis or blindness.

    There are currently ten disease modifying therapies (DMTs) available that have been approved by the U.S. Food and Drug Administration (FDA). Several more are poised to hit the market soon. While these drugs have become more effective at slowing disease progression and reducing the number of attacks a person with MS might have, none are able to repair or regrow myelin once damage has been done. But that could soon change.

    Moses Rodriguez, M.D., a neurologist specializing in MS at the Mayo Clinic, and his team initially identified rHIgM22, recognizing its ability to protect and stimulate the cells that make myelin, called oligodendrocytes.

    “This remyelinating antibody, if successful in clinical trials and approved, would be a novel approach to treating people with chronic neurologic deficits from multiple sclerosis or other similar conditions,” said Rodriguez in an interview with Business Wire. “We are excited that this Mayo discovery is now being evaluated in people with MS to determine its therapeutic potential.”

    The Clinical Trial Experience

    First-in-human (FIH), Phase 1 studies are typically conducted on a small number of patients to gauge the effectiveness and safety of a drug that has already been tried successfully on animals.

    For this study, which is expected to be completed by September 2014, 60 participants with MS will be randomly given infusions of either rHIgM22 or a placebo. The study’s design is “double-blind,” meaning that neither the volunteers nor the researchers know who will be given the real drug.

    Participants will receive escalating doses of the drug over a 90 day period, and the infusions are given in an inpatient hospital setting.

    “The day of the actual infusion I had to be admitted to the hospital for three days and two nights,” said a study participant from the Midwest who asked to remain anonymous. “Before getting the infusion, I had to give a urine sample, several tubes of blood, and have an EKG and then was hooked up to two different types of heart monitoring. I had two IV lines put in, one for the infusion and one for obtaining blood. The study had a very strict schedule for blood draws, vitals, EKG's, EDSS [neurological exams], physical exams, and walking 500 meters. I was watched very closely for the entire time I was infused and afterwards.”

    For human volunteers, a FIH study poses the greatest risk since, by design, it is the first time the new drug is used on humans. Recruiting volunteers for a FIH study can prove daunting, as people are often reluctant to risk their lives for research.

    “I did the study because I felt the need to push this potential drug forward,” said the study participant. “If the data collected throughout this Phase I study indicates that it works in humans the way it did in mice, it is huge for the MS community and even possibly other central nervous system disorders.”

    But moving from animal models or even FIH studies to a treatment that is FDA-approved often takes many years. “I know I may not benefit from it,” the study subject said, “but if my participation will in any way, shape, or form help someone else that is diagnosed with MS in the future not have to worry about becoming disabled or progress because we now have a drug that will repair myelin and restore nerve function, then it will be totally worth it!”

    Standing Up to MS

    Restoring nerve function is the holy grail of treatments for MS. For those with progressive forms of the disease, there is nothing current DMTs can do. But those who experience what is considered permanent disability from MS may still benefit from rHIgM22. Depending on how effective it is at repairing damaged nerves, these patients might one day be able to literally stand up to the ravages of MS.

    For more details on this clinical study ... visit http://www.clinicaltrials.gov/ct2/sh...acorda&rank=12
    .
    The entire Healthline article is available here.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Distinguished Community Member SalpalSally's Avatar
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    Thanks too, Agate. Sounding even better!!
    Love, Sally


    "The best way out is always through". Robert Frost







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    Distinguished Community Member agate's Avatar
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    You're right though, Sally--it will be a long road, undoubtedly.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Things sound so good and then when we get down to reality we have to realize the time frame we are talking about. If I had read this back when I was first diagnosed I would have been doing cartwheels, but through the years I have learned!!!
    Virginia

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