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Thread: Oral drug BG 12 (dimethyl fumarate) may be available by 2012

  1. #1
    Distinguished Community Member agate's Avatar
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    Default Oral drug BG 12 (dimethyl fumarate) may be available by 2012

    From the Rocky Mountain MS Center e-News, August 24, 2011:

    Breaking News
    Oral Drug: BG 12

    Dr. Timothy Vollmer

    Oral BG-12, also known as DIMETHYL FUMARATE, was originally used to treat psoriasis. It is now being investigated for use as an oral agent in people with relapsing-remitting multiple sclerosis (RRMS). This drug may represent a new class in treatment for multiple sclerosis, could potentially be neuroprotective, and may perform best as part of a combination therapy plan.

    Early this year BG-12 met positive top-line results from DEFINE, the first of two Phase 3 clinical trials designed to evaluate this drug as a monotherapy in people with RRMS. Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a significant reduction in relapse at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging lesions, and in the rate of disability progression as measured by the Expanded Disability Severity Scale (EDSS) at two years.

    In addition to meeting the primary and all secondary endpoints, initial data from the trial showed that BG-12 demonstrated a favorable safety and tolerability profile. The overall incidence of adverse events and serious adverse events was similar among the placebo group and both BG-12 treatment groups. The safety profile was consistent with what was seen in the published Phase 2 study of BG-12.

    Further analyses of the DEFINE study are ongoing, and the company anticipates presenting detailed data at a future medical meeting. Results from a separate Phase 3 trial called CONFIRM will compare BG-12 and Copaxone against a placebo and are expected in the second half of the year.

    BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008. Further evaluation of data and ongoing studies is needed, but if this drug performs well, it could be available in pharmacies by mid 2012.

    The article can be seen here.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

  2. #2
    Distinguished Community Member renee's Avatar
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    Up-upstate NY where it gets cooooold.


    I have been on Rebif for less than 5 months
    and already the experience is getting old and very tiresome.

  3. #3
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    I love to see new drugs being tested. I have found that MS is a fickle disease, and very much it's own person. One drug, I feel will not be the answer for most, for a very long time. I think the effectiveness of a treatment wears thin after a while, and we need to move, (trade off) to something new, sometimes completely different. SO this is very, very good news


  4. #4
    Distinguished Community Member
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    Oct 2006
    Red Sox Nation :D


    "Administered" how? Does anyone know?

    Oops! I just found it in the title. It's oral. Goodie, goodie gumdrops:)

    Thanks Agate.
    Last edited by stillstANNding; 09-02-2011 at 01:16 PM.
    There comes a time when silence is betrayal.- MLK

  5. #5
    Community Member Lady's Avatar
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    Oct 2006
    USA~ Dx MS 1981

    Question It is an old drug.

    Dimethyl fumarate is an ester and an α,β-unsaturated electrophilic compound, undergoing reactions typical to them. It is also a diene acceptor in the ordinary Diels-Alder reaction, where the reactivity of its vinylidenic bond is enchanced by the two electron-withdrawing ester groups. Due to the geometry of the starting ester, the Diels-Alder product will have a trans configuration.

    Dimethyl fumarate is used to treat psoriasis.[2] It is a lipophilic, highly mobile molecule in human tissue. However, as an α,β-unsaturated ester, dimethyl fumarate reacts rapidly with the detoxifying agent glutathione by Michael addition. When administered orally, it does not survive long enough to be absorbed into blood*confused

    Another use for dimethyl fumarate is mold inhibition, mostly for leather products
    Tests in mouse models have been conducted with the aim of using it as part of a specific cancer treatment.[4][5]

    Dimethyl fumarate has been found to be an allergic sensitizer at very low concentrations, producing extensive, pronounced eczema that is difficult to treat

    Concentrations as low as 1 ppm may produce allergic reactions.[6] There are only a handful of equally potent sensitizers.[7]

    The extreme sensitizing risk was brought to public attention by the "poison chair" incident, where Chinese manufacturer Linkwise produced two-seater sofas with dimethyl fumarate sachets inside to inhibit mould while they were in storage or transport.[8][9] In Finland where the chairs were sold from 20062007, sixty users were given serious rashes.[7]


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