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Progressive MS: Positive Phase 3 Trial Results

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    Progressive MS: Positive Phase 3 Trial Results

    French firm's drug succeeds in pivotal trial for progressive MS


    LONDON, April 17 (Reuters) - An experimental drug comprising of a high-dose formulation of the food additive biotin has successfully helped patients with progressive multiple sclerosis in a major clinical trial, its French maker said on Friday.

    Biotin, also known as vitamin H, is already an approved food additive but the pharmaceutical-grade dose used in biotech company MedDay's drug MD1003 is 300 mg a day, which is 10,000 times the recommended daily food intake.
    While there have been a number of recent advances in the treatment of relapsing-remitting multiple sclerosis (MS), there are currently no effective treatments to slow or stop the gradual increase in disability in people with progressive MS.

    The progressive form the disease affects around 40 percent of MS patients.

    MedDay said a pivotal Phase III study with MD1003 met its goal of improving disability scores in patients after nine months and one year of treatment
    , potentially paving the way for the medicine to reach the market next year.

    Full details of the study results will be present at the annual meeting of the American Academy of Neurology in Washington on April 24.

    http://mobile.reuters.com/article/id...50417?irpc=932

    #2
    Thanks Marco This is really promising!!
    1st sx '89 Dx '99 w/RRMS - SP since 2010
    Administrator Message Boards/Moderator

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      #3
      Marco, you really have your ear to the walls on these new developments. And it is amazing that the two elements(?) that you have introduced in these posts are ( I am guessing) naturally occurring (vitamin H and biotin). Can this be true? I sincerely hope that it is true. Thanks for your diligence!

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        #4
        Oops! It seems that I misspoke about the Biotin. I read a few entries on the internet and realize that Biotin is also known as vitamin H. So it may be that the french scientists have identified that this can be a useful treatment. If this becomes something great, that means that a Frenchman identified the disease, (Charcot) and French scientists found a useful remedy. Wouldn't that be poetic. Oh if it would only come true !

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          #5
          What do these phase 3 trials mean to us, MSer's? Does this mean that Biotin will become the basis of a new treatment plan? Does this mean that the FDA is planning to accept this drug into the U.S. clinical trial stream? Where does this information go from here?

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            #6
            The Press Release is here: http://www.businesswire.com/news/hom...y#.VTsFdyFVhBc

            One of the better news articles is here: http://www.bioworld.com/content/meddays-md1003-hits-ambitious-endpoints-its-ms-phase-iii-trial

            SAS reported its phase III trial of MD1003 in progressive multiple sclerosis (MS) has met the challenging primary endpoint of improving mobility, with 12.6 percent (p = 0.051) of patients showing an improvement in either the Expanded Disability Status Score (EDSS) or a timed 25-foot walk (TW25), after nine months of treatment.

            At the request of the FDA, patients were assessed again at 12 months, when the improvement was maintained.
            In addition to prompting improvements in a significant proportion of patients, there was a decrease in the rate of disease progression of 67 percent in the treated group as a whole (n = 103).
            Overall, the mean change in EDSS in the active arm was -0.03 at 12 months, compared to progression in the placebo group of +0.13 (p = 0.015).
            "This is the first time there has been a study of a drug that not only prevents progression, but also improves a significant number of patients," said Frederic Sedel, CEO of Paris-based Medday.

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              #7
              Thanks Marco. This is news worthy of 'dancing in the streets' ! If I could dance ! Maybe some day soon !

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                #8
                Biotin...a cheap supplement. Why wouldn't you start taking it now? So I am.

                After doing some research there seem to be no risks associated with such a high dosage. Also, I wonder how they settled on 300mg as a trial dose?

                I've been taking about 50mg Biotin in a sublingual form now for about a week that should yield better absorption than the capsules used for the trial. I plan on giving it a go for two months.

                The only change I've noticed so far is greater energy.

                Apparently, Biotin is often used to promote hair and nail health, which may make sense in respect to myelin health/growth because many B-vitamins are essential for both.

                You can buy sub-lingual Biotin 5mg tabs for about three bucks at Swanson's. They taste like cherry sweet tarts.

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                  #9
                  I started taking 1 single 10,000 mcg dose daily. I think I will do it for a month and then evaluate my condition. If there seems to be any positive changes, I will go for another month.

                  Comment


                    #10
                    From: http://www.md-health.com/Biotin-Side-Effects.html

                    Biotin Side Effects


                    Biotin, known as vitamin B7 or vitamin H, helps maintain the metabolism, hair and nails. While biotin can be very beneficial, taking too much can cause side effects including acne, allergic reactions, miscarriages and interactions with certain medications that can be dangerous.

                    Biotin may be known as vitamin B7 or vitamin H. This water-soluble B-complex helps specific enzymes throughout the body function more efficiently. You can get biotin from a variety of food sources such as cucumber, oats, dried fruit, eggs, cabbage, goat or cow's milk, cauliflower, royal jelly, raspberries, brewer's yeast or strawberries. You have a recommended dietary allowance that is very low for biotin.
                    Children should not get more than 5-12 units of biotin a day and adults should not get more than 20-30 units. It is rare that people suffer from a biotin deficiency, but it is possible. Those that are suffering from a biotin deficiency can take supplements to make up this difference. However, knowing the necessity and potential side effects of biotin can help you better determine if you need to take a supplement at all.
                    Biotin Side Effects

                    • Acne. Getting too much biotin in your system increases your risk of developing cystic acne on the chin and jawline. The reason why this occurs is unknown, but it is found that the acne fades a few weeks after you stop using biotin supplements. Make sure you take doses of biotin that are less than 2500 mcg or less each day and drink plenty of water while using biotin supplements to reduce your risk of developing cystic acne. You may need to experiment with different doses until you find the amount that works best with your skin.
                    • Allergies. Allergic reactions to biotin are not common, but they are still possible. People that have known allergies to vitamin B12 cobalamin or cobalt tend to be allergic to biotin as well. If you are suffering from an allergic reaction to biotin you may feel nausea, develop an itchy rash, tightness or pain in your chest and swelling of the throat and face. If you start to develop these symptoms call your doctor for help immediately as some of these developments can be fatal.
                    • Miscarriage. If you are taking high doses of biotin while you are trying to get pregnant it can increase your risk of suffering a miscarriage. The reasoning behind this is not clear, and no tests have been performed on humans to better determine the likelihood of this risk. Talk to a medical professional before taking biotin while pregnant to ensure your safety.
                    • Interactions. Biotin negatively interacts with anti-seizure medications and medications that help lower cholesterol, causing these medications to work less effectively. While biotin is helpful in regulating your metabolism and blood sugar levels, it can have a distinct effect on the overall blood glucose level in your body. If you are taking medications like cholesterol medication or anticonvulsants or treating a condition like diabetes, taking biotin can have an impact on your symptoms. It is rare that people have a life-threatening experience while taking biotin. There is only one recorded case where a woman that suffered from heart and lung condition known as eosinophilic pleuropericardial effusion developed life threatening conditions while taking vitamins B5 and B7 at high doses. After she stopped using these supplements her symptoms stopped. It is currently not known what role each of these vitamins or the combination of the two had in her symptoms.

                    Biotin Benefits

                    Although taking too much biotin may have potential side effects, biotin is one of the most vital nutrients in the B-vitamin complex, helping you promote growth and overall health. This nutrient carries carbon dioxide in the tricarboxylic acid cycle or TCA cycle. This helps your body convert protein, fat and carbohydrates into glucose energy to promote a better functioning metabolism. Biotin also helps you maintain the look and health of your hair and nails, preventing them from becoming brittle and dull. Diabetics find that biotin can help them manage their symptoms, as do those that suffer from depression or high cholesterol. Biotin can help you metabolize carbohydrates more effectively, helping you to manage your blood sugar levels.
                    Biotin Dosages

                    Some medical treatments may require you to take high doses of biotin. Treatment of Candidia albicans requires people to take as much as 500 mg of biotin each day to help manage this type of yeast infections. Some professionals also use high doses of biotin to treat diabetes patients since the vitamin can help you increase your natural sensitivity to insulin while increasing the enzymes that help you process sugar.
                    There is not currently a recommended daily allowance for biotin since it is very rare that someone suffers from a deficiency of the vitamin. In general, it is recommended that children take 10-20 micrograms of biotin when they are 3 and younger. Those between 4 and 6 may take 25 mcg per day, those between the ages of 7-10 can take 30 mcg each day and those older than 10 can ingest 30-100 mcg of biotin daily. There are 1000 micrograms for every milligram, so taking 5000 mg is an extremely high dose of biotin. These types of treatments should not be attempted without direct supervision from a physician to avoid potential side effects.


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