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Thread: MIS416 for SPMS gets US patent

  1. #1
    Distinguished Community Member agate's Avatar
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    Default MIS416 for SPMS gets US patent

    It's really unusual to find any research being done toward helping people with SPMS. This drug has had only small studies, apparently, but it just might be useful. (Thanks for the info, Peg!)


    US patent for new MS drug

    A new drug for the treatment of secondary progressive multiple sclerosis (SPMS) called MIS416, developed by New Zealand biopharmaceutical company Innate Immunotherapeutics, has been granted a patent in the United States.

    Innate’s chief executive Simon Wilkinson says the US patent is a significant milestone as the US market represents around 70% of the worldwide MS market by revenue. He says currently there are no drugs approved to effectively treat SPMS.

    The granting of the patent comes ahead of the world’s largest annual gathering of the healthcare/pharmaceutical investment sector in early January. The JP Morgan conference in San Francisco attracts major investors and pharmaceutical companies. While big listed companies take centre stage with their plans for the coming 12 months at the conference, Mr Wilkinson says companies like Innate will also be there talking with potential investors.

    "Following the success of our Phase 2A trials, where the data showed 80% of the patients had at least a 30% (or greater) improvement in at least one measure of MS related clinical status, we have attracted interest from both pharmas and investors," he says.

    Innate is now looking to convert this interest into funding for a larger randomized Phase 2B clinical trial. Meanwhile patent applications for MIS416 have been filed in other major markets including Europe, United Kingdom and Australia.

    In parallel with the planning for the 2B study, Innate has expanded its NZ 'compassionate use' access programme to allow 12 patients from the completed 2A trial to stay on treatment at the patients’ request. This brings the total number of patients with progressive MS who have received MIS416 on compassionate grounds to 21.

    In 15 patients with SPMS who have received six or more doses, 13 (87%) have reported modest to significant improvement in their health-related quality of life.

    Of the seven patients who have been on treatment for 20 weeks or more, six (86%) report sustained improvements. MS related quality of life improvements are measured using the internationally accepted "MS Quality of Life Inventory" (MSQLI) assessment tool.
    The article appeared here: http://www.voxy.co.nz/health/us-pate...-drug/5/143780
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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  3. #2
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    Agate, thanks for this. It gives a few more of us hope. However, I assume that this means it would be years away from being put on the market, unless it is so good that it gets a fast track through. It did not say how it is given. Not that I really care that much if it just would help those of us who have no other means of being helped.

    I am SPMS and on Rebif simply because they have not proven that it does "not" help those with SPMS. Just maybe not as much as people with RR, but I have always felt the need to be trying something to feel I am helping myself. My Doctor keeps me diagnosed as RR in order to let me stay on it.

    This is good news!
    Virginia

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    Small study.

    Much hope.
    ANN
    There comes a time when silence is betrayal.- MLK

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    Thanks Joan, Can't wait to try it.
    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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    Virginia, it sounds as if it is being fast tracked:

    NZ biopharma has promising MS drug trial results

    Tuesday, 19 June, 2012 - 13:00 New Zealand biopharmaceutical company Innate Immunotherapeutics says trials of its drug to help people with chronic, progressive multiple sclerosis (MS) are showing positive results.

    Simon Wilkinson, chief executive of Innate Immunotherapeutics, says results of the Phase 1/2 clinical trial have shown MIS416 to be well tolerated and identified a clinical dose for further evaluation.

    MIS416 is the lead product from the Auckland-based biopharma's proprietary immune modulating microparticle technology.

    Neurologist Professor Tim Anderson, co-principal investigator for the study, says the preliminary data indicate that MIS416 was safe and well tolerated. The MS-related clinical status assessment tools used during the study also indicate that the trial agent may have had some positive effect for many of the treated patients.

    During the dose confirmation portion of the study, eight of 10 patients with secondary progressive MS treated with MIS416 for 12 weeks showed some improvement in their MS-related signs and symptoms.

    "For example, 50% of the study subjects showed some improvement in EDSS scores over the relatively short 12 week duration of the trial," Professor Anderson says. "These interim results are encouraging and merit the consideration of a randomised, controlled trial in patients with secondary progressive multiple sclerosis."

    Innate Immunotherapeutics expects to complete the current Phase 1/2 study and announce final results in late 2012. It then plans to enroll MS suffers in 2013 for a 12 month Phase 2B study to investigate the sustainability of the improvements in seen in the first study.

    "We plan to conduct most of the next study in Australia, to take advantage of that country's greater patient availability and the financial support offered by the Australian government," Mr Wilkinson says. "If we can get appropriate local support it would be good to also have trial sites in New Zealand."

    Rosie Gallagher, National Director, Multiple Sclerosis Society of New Zealand, says the research is an exciting and extremely positive move.

    "Disease modifying therapies for those with MS tend to be of the immune-suppressant variety and are specifically for those with the relapsing-remitting form of the disease," she says. "However, these treatments have little to no effect on secondary progressive MS patients. This is a worry for the future, as around 75% of those with the relapsing-remitting form of the disease will eventually move into being classified as secondary progressive.
    "We welcome and encourage more research into MIS416, which, as well as potentially offering relief to those with this debilitating chronic illness, also gives hope to those with secondary progressive MS in that they may finally have a tangible symptomatic treatment option."

    In addition to financial support from the New Zealand Ministry of Science and Innovation, Innate Immunotherapeutics also has the support of the United States-based National Multiple Sclerosis Society. The society's venture capital arm, Fast Forward, accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS.

    Dr Timothy Coetzee, Chief Research Officer at the National Multiple Sclerosis Society, says it is pleased to help advance Innate's important research, which is designed to speed the development of an effective treatment for secondary progressive MS.

    Innate Immunotherapeutics is also collaborating with New Zealand and US universities that specialise in oncology research, to conduct preclinical studies of MIS416 in other applications, including treatment vaccines for a number of different cancers.



    http://www.voxy.co.nz/health/nz-biop...sults/5/126722

    This may give a clue about how it's administered--maybe once or twice a week intravenously?
    Safety:

    Animal toxicology studies have demonstrated that acute, twice weekly (for 4 weeks), and once weekly (for 26 weeks) i.v. administration of MIS416 is well tolerated and at doses up to 20 times the target human dose, observed effects were not explicity adverse and were the result of the drug's extended pharmacological effects.
    http://www.innateimmunotherapeutics.com/lead-candidate
    Last edited by agate; 01-14-2013 at 11:25 AM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Default Sour Grapes

    Looks like another drug developed to hit a number of different ailments such as influenzia, plague, breast & lung cancer, TB, maleria, etc. and not specifically developed for SPMS but developed for broad application and investment potential.

    Only 8 out of 10 SPMS reported any improvements to quality of life issues. That is not enough patients to even count as a qualifying clinical trial.

    Why is it being reported as an effective treatment for SPMS?

    Gabriella
    Last edited by Gabriella7; 01-16-2013 at 08:45 PM.
    Progressive/Relapsing MS, Myasthenia Gravis, Spinal Stenosis, Degenerative Disc Disease, Diabetes, Hypertension, Hashimoto's Thyroiditis
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    "Life is mostly froth and bubble, two things stand like stone. Kindness in another's trouble, Courage in your own"........Adam Lindsay Gordon

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  13. #7
    Distinguished Community Member agate's Avatar
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    We're kind of a jaded bunch here, no doubt about it. Maybe we've tried so many "remedies" already that one more coming down the pike just leaves us among the last to line up for it.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Agate, you might be right to some extent. However, I think it is more that it just seems so far away that many of us think it might never get to us. We have waited so long for so many different things just to see them fade away and not materialize. I just hope this is not another one of those. I guess I am one of those people who have gotten to the point that "I want something and I want it now". I know that's not realistic where MS is concerned and I get frustrated.

    I printed off all the articles so that I could take them to my Neurologist in March to see if he has heard anything, but I bet he hasn't. I will keep taking everything I can to him as long as it is reasonable and not something that will make me look like a nut.

    Just keep coming up with things! Thanks!!!
    Virginia

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    I really can't argue that we are or are not jaded. I think we all would like to see the research that is done to be for the benefit of the multiple sclerosis patients instead of just a broad spectrum "hit or miss" pharmaceutical that might work for some of us. Think about what this new drug is directed toward and how different all these diseases are in cause and effect..... cancer.....TB.....plague (I thought that was cured long ago)....malaria?

    The NMSS claims to be raising money for research into the cause and treatment of multiple sclerosis so where are the results???? Really.... every drug that I have been offered was originally developed for another disease such as cancer...... and not specifically developed for MS. This is what I see in the information presented here....it is designed to be used in a number of different diseases and vaccines. The NMS society's venture capitalist are using FDA approved drugs which didn't work out for other diseases. That is probably why these drugs don't work for MS either.

    Why isn't the money for research raised by the NMSS used for research into treatments for multiple sclerosis only? If questioning the facts of how the research money is being spent makes me a "jaded" person then I guess I am. I would like to see research being conducted into the cause of MS and then researchers could use that information and develop a treatment or even a cure! Just because the FDA approves a drug to treat any number of other diseases does not mean it is a drug that will help PwMS!

    In case anyone notices, I added more comments after rereading the articles and getting "hot" under the collar! This is just a big smoke screen to keep us thinking something big is coming.

    Gabriella
    Last edited by Gabriella7; 01-16-2013 at 09:01 PM. Reason: additional comments
    Progressive/Relapsing MS, Myasthenia Gravis, Spinal Stenosis, Degenerative Disc Disease, Diabetes, Hypertension, Hashimoto's Thyroiditis
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    "Life is mostly froth and bubble, two things stand like stone. Kindness in another's trouble, Courage in your own"........Adam Lindsay Gordon

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    Hi Agate. I have recently read & have spoken with a pharma co. that is doing trials with Domperidone for SPMS'rs. Apparently this med is supposed to be helpful for walking. Peace

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