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Thread: Clinical Trials

  1. #81
    Senior Member KIM's Avatar
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    Here we go again

    Quote Originally Posted by KIM
    NOW MYSTERIOUS CHANGE IN DATES
    New Drugs and Therapies for Spinal Cord Injuries


    Neuraxo Biopharmaceuticals, a German biopharmaceutical company stands for pioneering the therapy of acute and chronic Spinal Cord Injuries with its proprietary technology platform: the Regeneration Promoting Treatment (RPT).
    As a first clinical application of the RPT Neuraxo is focusing on the clinical development of Cordaneurin® - a drug for the treatment of acute Spinal Cord Injuries which received Orphan Drug Status in 2004. In pre-clinical studies Cordaneurin® has already demonstrated its high efficacy in extensive recovery of sensory and motor function. Cordaneurin® will enter clinical trials in 2006.
    As a second application Neuraxo will take up the challenge to develop a therapy also for chronic injured patients. This cure called CordaChronTM will include additional components to Cordaneurin® such as the patent protected nerve growth stimulating factor, the chemokine SDF-1gamma. First clinical trials with CordaChronTM are expected in 2008.
    Neuraxo's pipeline is filled with additional new and promising drug candidates in the field of neurotherapeutic drugs.
    NEURAXO - New Dynamics for Neural Regeneration


    New Drugs and Therapies for Spinal Cord Injuries


    Neuraxo Biopharmaceuticals, a German biopharmaceutical company stands for pioneering the therapy of acute and chronic Spinal Cord Injuries with its proprietary technology platform: the Regeneration Promoting Treatment (RPT).
    As a first clinical application of the RPT Neuraxo is focusing on the clinical development of Cordaneurin® - a drug for the treatment of acute Spinal Cord Injuries which received Orphan Drug Status in 2004. In pre-clinical studies Cordaneurin® has already demonstrated its high efficacy in extensive recovery of sensory and motor function. Cordaneurin® will enter clinical trials in 2007.
    As a second application Neuraxo will take up the challenge to develop a therapy also for chronic injured patients. This cure called CordaChronTM will include additional components to Cordaneurin® such as the patent protected nerve growth stimulating factor, the chemokine SDF-1gamma. First clinical trials with CordaChronTM are expected in 2009.
    Neuraxo's pipeline is filled with additional new and promising drug candidates in the field of neurotherapeutic drugs.
    NEURAXO - New Dynamics for Neural Regeneration

  2. #82
    Senior Member Schmeky's Avatar
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    Thanx Kim for the update. Doesn't surprise me.

  3. #83
    Not sure whether this has been brought to your attention on this message board but thought it might interest a lot of you.

    #1



    This is from a research company in Israel and is definitely a reputable outfit. The company is called Proneuron and their website address is http://www.proneuron.com/index.html

    #2
    http://www.genengnews.com/news/bnitem.aspx?name=17054289

    "Q Therapeutics is an emerging biopharmaceutical company, venture-backed and privately held. The Company is developing products to treat debilitating diseases of the central nervous system. The Company's first product, Q-Cells(TM), is a cell-based therapeutic intended to replace the insulating myelin on damaged neurons and thus regenerate normal function of these neurons. Q-Cells are applicable to a wide range of demyelinating diseases, including multiple sclerosis (MS), cerebral palsy, spinal cord injury and white matter stroke. Clinical trials are targeted to commence in 2008 in Transverse Myelitis, a rapidly paralyzing, inflammatory spinal cord injury related to MS. Q's pipeline includes other cell products for treating diseases including Parkinson's and Alzheimer's Diseases and ALS, as well as peripheral neuropathies."
    Last edited by TheBaron; 05-09-2007 at 08:51 AM.

  4. #84
    Senior Member Schmeky's Avatar
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    Proneuron's lead product is ProCord, an experimental cell therapy that is being developed to treat acute spinal cord injury.
    Acutes only.

  5. #85
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    When I read cell therapy so and so I think it is just bogus these days. Know about the company of course and the serious collaborations. Proneuron Biotech. and Shepherd C, is serious as such, but media plays a role, but cell therapy is an overstatement and a word misused by many these days. Understanding of the cord and the network communication studies as for basal research to enter applied research is not. There is a difference here in all this, say for a sailor to drop the anchor wherever without having some understanding of the seabed underneath.

  6. #86
    Quote Originally Posted by Leif
    When I read cell therapy so and so I think it is just bogus these days. Know about the company of course and the serious collaborations. Proneuron Biotech. and Shepherd C, is serious as such, but media plays a role, but cell therapy is an overstatement and a word misused by many these days. Understanding of the cord and the network communication studies as for basal research to enter applied research is not. There is a difference here in all this, say for a sailor to drop the anchor wherever without having some understanding of the seabed underneath.
    Leif, it is so sad that we allow unscrupulous companies and others to destroy the reputation of therapies that they decide to use. It is sad. For example, umbilical cord blood has been successfully used for many conditions and is a perfectly legimate therapy. But it needs to be rigorously tested for each condition. It would compound the travesty if their failure to do so gives a good therapy a bad reputation so that doctors don't want to use them. Let's evaluate treatments based on their merits and evidence, not public perception of the therapies due to newspaper articles.

    I was really taken aback when various people wrote me about the story of the the Australian woman who was treated by Geeta Shroff with so-called human embryonic stem cells. Many of them were saying that they themselves or somebody they love should go there for the treatment, that if it worked for one person, it may work for them. This kind of thinking is frightening.

    I have no idea whether or not the cell transplant therapy helped this particular person, whether it was the physical therapy, or even the motivation that the procedure provided (I hesitate to call it a placebo effect until we actually have real controlled data). But, one case does not show that a therapy works, particularly a therapy that is as murky as the one that is being promulgated by Dr. Shroff. I am skeptical that the transplanted cells are really human embryonic stem cells, that the cells are acting as stem cells to begin with, and that intravenous or even intrathecal administration of these cells would be helpful to somebody with spinal cord injury.

    More than probably anybody else, I understand the urgency and the desperation that people feel. It is particularly irksome to me when companies and doctors take advantage of this desperation to offer unproven therapies with unsubstantiated claims of efficacy and safety. While I realize that most of the time the companies and the doctors are themselves convinced that the therapies work, because it would be epitome of evil if they were not convinced that it worked and they went ahead to sell the therapy, this does not ncessarily mean that the treatment is safe and efficacious. This is why clinical trials are necessary.

    Everybody assumes that clinical trials are just for the purpose of showing that things work. In fact, most companies don't want to fund clinical trials that show that a therapy does not work. It is almost impossible to get funds for clinical trials to show whether a therapy does not work. From what I can gather, hundreds or perhaps even thousands of people with various desperate neurological conditions are paying for cord blood cell transfusions based on claims that such therapies are 80% effective (or at least satisfying) and 100% safe. It is the responsibility of the company to document safety and efficacy. If they do not, who else would? Worse, if they do not, it is clear that they have no interest in determining the safety and efficacy of the treatment, since most such studies will show some safety problems and some limitations of efficacy.

    It is paramount that we don't condemn a therapy (such as human embryonic cells or umbilical cord blood cells) because some unscrupulous people have used them. That would the saddest thing of all, if a company or doctor were to taint a well by using it unethically. Cellular therapies are not only possible replacements for cells that our body are not adequately replacing. They are also the next generation of gene therapies, just packaged differently from a virus. They can be used to deliver growth factors and to provide a temporary bridge for axons to grow on. They are the future of therapeutics. The very reason that makes them so exciting is the same reason why so many scam artists are now surrounding them and offering them to people in fly-by-night clinics in out-of-the-way places.

    Wise.

  7. #87
    Senior Member spidergirl's Avatar
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    This is very interesting that you wrote this. In fact I was watching something on ABC on the news TODAY about some Iraqi War Veteran idiot going to Tijuana for an UBC blood stem cell procedure. He lived in San Diego which is just a hop, skip jump and away from Tijuana but still I was baffled that he would he even do this. I call him an idiot because Tijuana, Mexico is the last place I would go. I wouldn't even buy a pinnate there. The coverage was somewhat nice at least but than they had this other US Dr. Dr. Snyder come in and say that UBC stem cells will NEVER EVER cure spinal cord injury and they are not the right cells. He called them blood cells. Now I don't know if Dr. Young knows or you know who he is but this man straight put down everything the CHINASCINET stands for down. I was really in a state of shock. I am really exhausted right now to filter thru the internet and find the segment. It was on ABC at 6:00 PM in Los Angeles. (maybe someone else can post it if they can find it on utube ) This all just really coincides with a lot and leaves me scratching my head.

    Not to mention whoever this Dr. Snyder is said we are still decades away. I don't know where they found this guy to say anything. They found him under a rock. I mean they make regenerative therapies look like they are going to surface when cars are flying.


    Quote Originally Posted by Wise Young
    Leif, it is so sad that we allow unscrupulous companies and others to destroy the reputation of therapies that they decide to use. It is sad. For example, umbilical cord blood has been successfully used for many conditions and is a perfectly legimate therapy. But it needs to be rigorously tested for each condition. It would compound the travesty if their failure to do so gives a good therapy a bad reputation so that doctors don't want to use them. Let's evaluate treatments based on their merits and evidence, not public perception of the therapies due to newspaper articles.

    I was really taken aback when various people wrote me about the story of the the Australian woman who was treated by Geeta Shroff with so-called human embryonic stem cells. Many of them were saying that they themselves or somebody they love should go there for the treatment, that if it worked for one person, it may work for them. This kind of thinking is frightening.

    I have no idea whether or not the cell transplant therapy helped this particular person, whether it was the physical therapy, or even the motivation that the procedure provided (I hesitate to call it a placebo effect until we actually have real controlled data). But, one case does not show that a therapy works, particularly a therapy that is as murky as the one that is being promulgated by Dr. Shroff. I am skeptical that the transplanted cells are really human embryonic stem cells, that the cells are acting as stem cells to begin with, and that intravenous or even intrathecal administration of these cells would be helpful to somebody with spinal cord injury.

    More than probably anybody else, I understand the urgency and the desperation that people feel. It is particularly irksome to me when companies and doctors take advantage of this desperation to offer unproven therapies with unsubstantiated claims of efficacy and safety. While I realize that most of the time the companies and the doctors are themselves convinced that the therapies work, because it would be epitome of evil if they were not convinced that it worked and they went ahead to sell the therapy, this does not ncessarily mean that the treatment is safe and efficacious. This is why clinical trials are necessary.

    Everybody assumes that clinical trials are just for the purpose of showing that things work. In fact, most companies don't want to fund clinical trials that show that a therapy does not work. It is almost impossible to get funds for clinical trials to show whether a therapy does not work. From what I can gather, hundreds or perhaps even thousands of people with various desperate neurological conditions are paying for cord blood cell transfusions based on claims that such therapies are 80% effective (or at least satisfying) and 100% safe. It is the responsibility of the company to document safety and efficacy. If they do not, who else would? Worse, if they do not, it is clear that they have no interest in determining the safety and efficacy of the treatment, since most such studies will show some safety problems and some limitations of efficacy.

    It is paramount that we don't condemn a therapy (such as human embryonic cells or umbilical cord blood cells) because some unscrupulous people have used them. That would the saddest thing of all, if a company or doctor were to taint a well by using it unethically. Cellular therapies are not only possible replacements for cells that our body are not adequately replacing. They are also the next generation of gene therapies, just packaged differently from a virus. They can be used to deliver growth factors and to provide a temporary bridge for axons to grow on. They are the future of therapeutics. The very reason that makes them so exciting is the same reason why so many scam artists are now surrounding them and offering them to people in fly-by-night clinics in out-of-the-way places.

    Wise.
    Last edited by spidergirl; 05-25-2007 at 01:40 AM.

  8. #88
    Senior Member lynnifer's Avatar
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    And therein lies the crux of the problem ... there are so many conflicting ideas. One doctor says one thing, another says something totally different. Just in the other thread I posted about FES, Dr Young said everyone should try it. I emailed the Cleveland Clinic for FES a year ago and they said don't bother ...
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

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  9. #89
    Quote Originally Posted by spidergirl
    This is very interesting that you wrote this. In fact I was watching something on ABC on the news TODAY about some Iraqi War Veteran idiot going to Tijuana for an UBC blood stem cell procedure. He lived in San Diego which is just a hop, skip jump and away from Tijuana but still I was baffled that he would he even do this. I call him an idiot because Tijuana, Mexico is the last place I would go. I wouldn't even buy a pinnate there. The coverage was somewhat nice at least but than they had this other US Dr. Dr. Snyder come in and say that UBC stem cells will NEVER EVER cure spinal cord injury and they are not the right cells. He called them blood cells. Now I don't know if Dr. Young knows or you know who he is but this man straight put down everything the CHINASCINET stands for down. I was really in a state of shock. I am really exhausted right now to filter thru the internet and find the segment. It was on ABC at 6:00 PM in Los Angeles. (maybe someone else can post it if they can find it on utube ) This all just really coincides with a lot and leaves me scratching my head.

    Not to mention whoever this Dr. Snyder is said we are still decades away. I don't know where they found this guy to say anything. They found him under a rock. I mean they make regenerative therapies look like they are going to surface when cars are flying.
    Is this what you're talking about?

    http://sci.rutgers.edu/forum/showthread.php?t=82474

  10. #90
    Quote Originally Posted by lynnifer
    I emailed the Cleveland Clinic for FES a year ago and they said don't bother ...
    I was told the same thing, by a different clinic of course.

    But I met a really good therapist named Dan Boneratti who tried all
    sorts of e-stim on me anyway. No contraction, so no bike.

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