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Possible Cures for Type-1 in the News (November)

Discussion in 'Research' started by joshualevy, Nov 19, 2017.

  1. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    Merck Cancels "Smart Insulin" (MK-2640) After Unsuccessful Phase-I Trial

    This is the news everyone hoped we would not get. After completing a phase-I trial of "Smart Insulin" (also known as MK-2640), Merck has decided not to move forward with it. They have not published the results, but have published this: "MK-2640 was discontinued due to lack of efficacy".

    News report: http://www.pharmaceutical-journal.c...es/towards-a-smarter-insulin/20203828.article


    This was the first (and so far only) glucose responsive insulin to be tested in humans. However, there are several "smart insulins" being tested in animals, not to mention "smart artificial cells" and "smart membrane" based technologies, all aimed at automatically regulating the amount of insulin in the blood stream. I expect some of these to enter human trials in the next few years. So "smart insulin" may yet be a trail blazer, even if it itself was unsuccessful.

    If results from this study are ever published, I'll blog on them here. However, there is nothing forcing Merck to publish these results if they don't want to.

    Phase-II T-Rex Trial Update

    Caladrius Biosciences recently announced that they had enrolled the 70th patient (out of 111) in their clinical trial of CLBS03 for T1D. So it has taken them roughly 18 months to recruit 2/3 of the patients they need. If they can keep up that pace, they will finish recruiting in the third quarter of 2018, and finish collecting data in the third quarter of 2019, and publish in 2020.

    Previous Blogging: http://cureresearch4type1diabetes.blogspot.com/search/label/Polyclonal Tregs

    A quick summary of this treatment is as follows: remove one specific type of T regulator cell (called "CD4(+)CD25(+)CD127(lo)") from a person with type-1 diabetes. Grow them out so you have about 500 times more, and then put them back in the same person. Since regulatory T cells naturally regulate the body's immune system, and the patient now has more of them, the hope is that they will prevent the autoimmune attack which causes type-1 diabetes.

    They are recruiting patients in about 15 locations all over the US, so read the clinical trial registry to get a complete list and some contact information.

    News Report: https://www.caladrius.com/press-rel...clinical-trial-of-clbs03-for-type-1-diabetes/
    Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02691247

    SIMPONI (Golimumab) Starts A Phase-I Trial In Pre-Symptomatics

    Golimumab (sold as Simponi) is an immune system modulator, which has been approved in the United States and many other countries for treatment of several autoimmune diseases, so testing it on type-1 diabetes makes a lot of sense. This is the second trial underway for this drug. (The other one is called T1GER, and is for honeymooners.) Simponi has already been approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.

    This study is recruiting people who have two autoimmune antibodies (but no other symptoms of type-1 diabetes). They are recruiting 30 kids (aged 6-21), and will follow them for 17 months. Each kid will get 26 weekly injections. Half the patients will get Simponi and the other half will get a placebo. They hope to finish this study in mid 2021.

    This study is current recruiting in Linkoping University Hospital, Linkoping, Sweden, SE 58185.
    Study contact: 844-434-4210 JNJ.CT@sylogent.com
    They hope to start recruiting at other locations in Sweden and Finland soon.

    The unusual thing about this trial is that they will not measure any effectiveness data at all. The only data gathered will be safety and side effect data. No C-peptide data, no A1c, or insulin usage. That's very unusual for a type-1 diabetes study. In my experience, even the phase-I studies gather some effectiveness data.

    Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT03298542
    Previous Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02846545

    Joshua Levy
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
  2. katerinas

    katerinas Approved members

    Apr 20, 2010
    Really sad to hear about Merck but not at all surprising after all these years.
  3. Ali

    Ali Approved members

    Aug 1, 2006
    Oh I am sorry. I really hope for a smart insulin as that is such a simple inexpensive way to help all people around the world. It does not matter if you are a T1 or T2, you would only need needles, still a big issue in many parts of the world, and a bottle of insulin! I assume maybe test strips but probably cheap urine strips would help figure out the dosing. I love all cgms and pumps and AP advances but that is just not realistic for so much of the world living with T1.
  4. Pavlos

    Pavlos Approved members

    Nov 28, 2007
    Awful news about Merck. Smart Insulin would have been the next best thing to a cure.

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