Oral formulation of salmon calcitonin – DMOAD

2»

Comments

  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    What a xmas present this could be – results showing that Oral Salmon Calcitonin is a DMOAD. As soon as I hear, I will post what I know. Good or bad.
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    Results in!

    The recently completed study assesses the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee and had three co-primary endpoints. Novartis informed Emisphere that preliminary analysis of the data from this study shows that the endpoint for the first of three co-primary endpoints, joint space width narrowing, was not met. Novartis also informed Emisphere that results regarding the other two co-primary endpoints indicated clinical efficacy related to symptom modification (WOMAC scales: pain, function). In addition, according to Novartis, MRI analyses suggested an effect on cartilage.

    Looks like it only relieves pain. However it has no dangerous side effects to report. Does anyone know what happens now. Will it go for FDA approval?
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    More info regarding salmon calcitonin. Emisphere emailed me this the other day.

    Under a co-development collaboration with Novartis, Nordic Bioscience is using our Eligen® drug delivery technology in combination with salmon calcitonin to treat osteoarthritis and osteoporosis. For osteoarthritis, Nordic Bioscience completed one Phase III clinical trial and is awaiting first interpretable results from a second Phase III clinical study. A Phase III clinical study for osteoporosis is also currently underway. The Company anticipates that data from these clinical studies will become available during the fourth quarter 2011.

    So before the end of the year. we will know what we have here. 8 year waste of time and money or something doctors may be able prescribe.
  • dreamdaisy
    dreamdaisy Member Posts: 31,520
    edited 30. Nov -1, 00:00
    I have to say that my money is on the waste of time etc but I hope I am wrong. DD
    Have you got the despatches? No, I always walk like this. Eddie Braben
  • frogmorton
    frogmorton Member Posts: 30,027
    edited 30. Nov -1, 00:00
    [

    So before the end of the year. we will know what we have here. 8 year waste of time and money or something doctors may be able prescribe.[/quote]


    Wouldn't it be graet if it was the latter.

    Hope you are doing ok Sturge?

    Toni x
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    Results show it met 2 out of 3 endpoints on pain and function, it also showed it increased cartilage volume over 24month time frame. So we could have our first dmoad on our hands. The next 4-5 months will be interesting.
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    Emisphere have just released this press release, CEDAR KNOLLS, N.J., Dec. 14, 2011 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (OTCQB:EMIS) ("Emisphere" or the "Company") announced today that Novartis Pharma AG ("Novartis") has informed the Company that it will not pursue further clinical development of the investigational drug SMC021 (oral calcitonin) being studied by Nordic Bioscience (the exclusive license partner of Novartis) as a treatment option in two indications, osteoarthritis (OA) and for post-menopausal osteoporosis (OP) and that it will not seek regulatory submission for SMC021 in OA or OP indications.

    Novartis advised the Company that its decision to stop the clinical program of SMC021 in both indications was based on analysis and evaluation of data from three Phase III clinical trials (two in OA and one in OP) that showed that while SMC021 displayed a favorable safety profile, it failed to meet key efficacy endpoints in all three trials.

    Back to the drawing board I think. What a shame.
  • dreamdaisy
    dreamdaisy Member Posts: 31,520
    edited 30. Nov -1, 00:00
    I have a feeling, sturge, that arthritis is one of those things that will never be fixed. Until they really know why it happens how can they? The inflammatory arthritses have a definite cause (and defy most treatments, very few sufferers have total success and fully regain their lives, the rest of us have to compromise) but the 'wear and tear' version is just that. OA is caused by life so there is a cure, but it ain't necessarily the one people want. DD
    Have you got the despatches? No, I always walk like this. Eddie Braben
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    Sorry dreamdaisy, but you have completely lost me there, I don't understand what you are saying. And I find your general comments towards anything which is related to new techniques, therapy or treatment to OA - negative. I only post such information to perhaps inform and give people hope. Then you rail road in with all your doom and gloom, making my efforts seem pointless. Its sad to here this drug didn't work, but we must stay positive. I am one of few people in the UK to try a stem cell injection, suppose you are just going to tell me this type of treatment is a waste of time too. I hope not as millions of pounds is being ploughed into to stem cell and tissue engineering. I'm sure in 20 years time things will be different and we will have more options other than surgery.
  • dreamdaisy
    dreamdaisy Member Posts: 31,520
    edited 30. Nov -1, 00:00
    I'm all for new techinques and treatments, indeed I took part in some very unpleasant research for some asthma meds when younger but arthritis is such a stubborn thing to treat. There are over ten million arthritics in the UK, all of them struggling to some extent or another, and speaking as one whose life is dominated by pain, injections and foul meds on a daily basis I guess I cannot help but feel a little blue about it all. I've had radiation treatment in both knees, all sorts of meds but the inevitable has happend in that I've just bought a rollator: I keep trying to sell it to myself as being a very positive thing but hell, I'm only 52, can no longer walk without any form of support be it wheels or sticks and yes, that feels unjust. I also have both versions of this, the meds for the one sort don't touch the other so I do know how much a battle this can be. I've been there and done that with treatments which are supposed to make a huge difference and they haven't so again the compromise has to come from me. Today I'm off for a bone scan to see how much they have been affected by the steroids, if at all, so at least this should tell me one way or another. I realise that you are equally affected by this sturge, and I'm all for the research (and hats off to you for keeping us abreast with it all) but I do think the answer is a long way off. Do you find the cold weather makes yours worse? DD
    Have you got the despatches? No, I always walk like this. Eddie Braben
  • sturge8
    sturge8 Member Posts: 164
    edited 30. Nov -1, 00:00
    My pain is just a constant burning feeling, not matter what the weather is and it feels like the joint is being pinched.

    Today technology is more advanced, Biotech is big at the moment and so is regenerative therapy. Something surely will work. Thankfully my stem cell injection wasn't dangerous, so if it doesn't work. No harm done.