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Thread: Jerry Silver and Other Discussion from ChinaSCINet Update

  1. #461
    Quote Originally Posted by Wise Young View Post
    No, Paolo. Most of these tasks have been already accomplished for testing umbilical cord blood cells and lithium. You haven't helped.

    Instead of being so negative, perhaps you can answer the question that I asked Pelican. What therapy would you suggest?

    Wise.

    Professor what is your opinion on epidural stimulation of Dr. Harkema louiseville in conjunction with your treatment to stimulate the spinal cord? and tell me your general opinion on the epidural stimulation of the spinal cord and I also wanted to know why the electrodes year positions at the lumbar level and not at the level of the spinal cord INJURY
    JustaDollarPlease.org

  2. #462
    Quote Originally Posted by jsilver View Post
    Wise, what is holding back the use of chondroitinase in your future plans? Do you think the hundreds of positive pre-clinical results at acute stages as well as positive results now in several long chronic models aren't sufficient?
    Jerry, as you know, I am a strong supporter of taking chondroitinase to trial. ChinaSCINet is ready to do so. Wise.

  3. #463
    Quote Originally Posted by Fly_Pelican_Fly View Post
    Thanks for your comprehensive reply Wise.

    I agree that the advisory boards are often so political that they end up choosing "nothing" by default. This is definitely an issue that needs to be resolved.

    I agree that advisory boards must be suitably skilled members with academic, pre-clinical, clinical and commercial backgrounds. A balance is vital. Patient representation would also be useful if possible. Perhaps members of advisory boards should be asked to "reapply" for their membership on an 24-month basis? It is after all an honour to serve on a scientific advisory board.

    I agree that clinical trials are incredibly tough to execute. I think everyone appreciates the incredible amount of hard work that has been put in to make this a reality.

    I agree that the success of a trial should be measured by robustness of the data produced ie reliable answers either way. I understand your theory of 'elimination'. There's nothing wrong with it 'in theory'. However, in reality, to sustain a non-commercial trial network that relies on funding from supporters affected by chronic SCI you may only have a finite number of chances before the faith and support is lost. We are a fickle bunch unfortunately At the same time, although China has a large population of SCIs - the number willing to take part in trials is still finite. Will participants continue to sign up in sufficient number when the network has a track record of multiple trials without 'success in their eyes'? Something to consider.

    We know that combination therapies are incredibly complex to plan clinical trials for. And I, like everyone here, want to see therapies racing through the pipeline. But, as an 'investor' who has to tirelessly interface neutrally with dozens of hungry scientists all competing, politicking, bamboozling and sniping, I'd personally like to see an additional step in the pre-clinical work for combination strategies. This way we may see at least one or two more of the dozens of scientists agreeing that the therapy is sound for clinical trial. And that would make me more confident in my 'investment' ie de-risked. Of course, it could still fail - but that's risk management.

    In terms of therapies to take to trial - well, there is one therapy that everyone seems to be sitting on their hands about. And everyone in the field seems to be OK that one commercial entity can hold it's potential in the pipeline when there is enough data to show that breathing in chronic injuries could be restored. And yes, there is a human-grade version of the agent available elsewhere. That's a crying shame - actually, that's a travesty for those on ventilators!
    Thanks. We have agreement on many points. Let me comment on three issues that you raised:
    Dearth of subjects if the network does not encounter success in the first trials. Of the hundreds of thousands of people with chronic spinal cord injury who would be eligible for clinical trial, I don't think that we will have trouble recruiting 240 of them for our upcoming phase III. While success in the first trial may attract more subjects for future trials, I am not sure that we want to attract subjects for that reason alone. People volunteer for the trials because they want to help their community identify therapies that restore function. We do our very best to choose the therapies that we think are safe and the most likely to restore function to them. We are committed to offering future trial options to people who have already participated in our trials. We will work together identify the most effective and safe therapies for the whole community. This is the best approach that we can take.
    Achieving greater consensus amongst scientists for which treatment to take to trial. Who is this consensus for? Is it for the SCI community, companies, the regulatory agencies, clinicians, or the investors? If the consensus is intended for the investors, so that they will invest in the trials, the risk vs. profit analysis will probably proceed as follows. If investors can get regulatory approval on a product at a low cost, such as $12 million vs. industry standard of $2 billion, it would be a very attractive investment even if the risk of failure is relatively high. If the consensus is intended for companies who have potential products for trial, the knowledge that the trial will be done efficiently and rapidly for a limited investment would be more important than the promise of the therapy, which the company believes in anyway. If the consensus is for the SCI, scientific, clinical, and regulatory communities, it would be nice to have more support but the results of the trials will be the only things that matter and will speak louder than any pre-trial consensus. Should we be delaying trials for such consensus? Do you see any prospect of consensus amongst spinal cord injury scientists now?
    Better risk management. What are the risks of clinical trials? Clinical trial risks fall into three categories: clinical trial execution, product safety, and treatment efficacy. Obviously, if the trials don't get executed well, the investment is wasted. A serious safety issue can kill a product (or worse, somebody). Even minor safety issues will make the product more difficult to approve and eventually to market. Treatment efficacy is of course important because an ineffective therapy will not receive regulatory approval. However, a robust mechanism of action is often considered more important than preclinical evidence of therapeutic efficacy in animal models because animal models don't always predict the human response and some therapies cannot be adequately tested in animals.

    With regard to chondroitinase, please consider the following. Acorda Therapeutics has licensed a use patent for chondroitinase for spinal cord injury from James Fawcett and his colleagues. To my knowledge, Acorda does not hold the composition of matter patent, which is held by a Japanese food company that discovered the bacterial gene. They do not hold the processing patent, which was filed by another Japanese company (Seikagaku) that developed methods to isolate and purify chondroitinase. Neither of these companies have licensed their patents to Acorda. Seikagaku apparently has licensed its processing patent to another Japanese company. Also, both of these patents are relatively old and will probably run out in a relatively short time. Finally, several competing products may soon make chondroitinase enzyme obsolete as a therapy.
    1. Jerry Silver has a small molecule drug, a polypeptide that can be given systemically to block the receptor that mediates the inhibitory effects of CSPG. I assume that it has been licensed to a company. There are reports that it is effective.
    2. Emory University has patented a form of chondroitinase that is less heat sensitive and apparently more potent that the standard bacterial chondroitinase.
    3. Several groups have successfully inserted chondroitinase into cells that then secrete the enzyme, so that these cells can be transplanted into the injury site and deliver chondroitinase locally at much less cost.
    4. A human enzyme that breaks down chondroitin-6-sulfate-proteoglycans has been discovered.


    I don't know how much these factors are influencing Acorda's decisions but they have said that they are doing safety and other studies to produce chondroitinase for trial. These studies are not trivial and require substantial work, investment, and time. I am sure that if a foundation said that they would be willing to fund a chondroitinase trial, it could be done.

    Wise.
    Last edited by Wise Young; 02-11-2013 at 12:57 PM.

  4. #464
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Wise Young View Post
    Jerry, as you know, I am a strong supporter of taking chondroitinase to trial. ChinaSCINet is ready to do so. Wise.

    So wise, can you get ahold of some chondroitinase as soon as possible?? any plans in the works?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  5. #465
    Quote Originally Posted by 6 Shooter View Post
    So, just how would you propose this be done on live humans?
    6 Shooter,

    I like your question!
    My disappointment was directed to the fact that not even in animals the chronic lesion environment has been studied more intensively at chrinic stages. That would be the first step.

    About humans one important thing to do is to do more histology studies of spinal cords of people with SCI when they die (if they agree to donate it to scienze).
    At the same time you remember for sure about Carlos Lima procedure which included the removal of the "scar". That has been a great opportunity to study the human scar, I am not sure if it has been used as best as possible.
    Now a similar procedure should be done in a clinical trial in New Zeland.
    To analize carefully the tissue removed from the spinal cord it would be extrimely interesting I think. I hope it will be done, perhaps we should make sure of that.

    Another important way forward is to develop better imaging technologies. In animals that could become as good as to replace histology.
    Next step would be to use the same imaging in humans so that you have a precise idea of each leasion environment to take the most appropriate approach for every single case.

    Just as an example here is one of the latest imagine technology: http://spinalcordresearchandadvocacy...ticle-imaging/

    If you like chemistry here is a lab who has used a chemical approach to study the lesion environment:
    http://chemistry.caltech.edu/~fucose/publications.html

    I hope someone can add more info/ideas.

    Paolo
    Last edited by paolocipolla; 02-11-2013 at 03:03 PM.
    In God we trust; all others bring data. - Edwards Deming

  6. #466
    Senior Member lunasicc42's Avatar
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    Wise, is it possible to privately buy and test some chrondroitinase in trial? Why isn't this possible?

    http://www.amsbio.com/productpage.as...STATES&cur=USD
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  7. #467
    Quote Originally Posted by lunasicc42 View Post
    Wise, is it possible to privately buy and test some chrondroitinase in trial? Why isn't this possible?

    http://www.amsbio.com/productpage.as...STATES&cur=USD
    Lunasicc42,

    To my knowledge, clinical grade chondroitinase is not available from any source at the present. Who will inject it into the spinal cord?

    Wise.

  8. #468
    Quote Originally Posted by fti View Post
    Professor what is your opinion on epidural stimulation of Dr. Harkema louiseville in conjunction with your treatment to stimulate the spinal cord? and tell me your general opinion on the epidural stimulation of the spinal cord and I also wanted to know why the electrodes year positions at the lumbar level and not at the level of the spinal cord INJURY
    fti,

    Until they find that it produces more consistent walking, I would hold off. I am not sure how many subjects Dr. Harkema has been testing but it must be many dozens or even hundreds. I am aware of only a few patients that are responding to the epidural stimulation and treadmill walking.

    Wise.

  9. #469
    Quote Originally Posted by Wise Young View Post
    Lunasicc42,

    To my knowledge, clinical grade chondroitinase is not available from any source at the present. Who will inject it into the spinal cord?

    Wise.
    Wise,

    Seikangaku is doing clinical trial for herniated disc using chondrointinase, I guess they must have a clinical grade of it.

    http://www.clinicaltrials.gov/ct2/re...&Search=Search

    Screw Acorda.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  10. #470
    Quote Originally Posted by Wise Young View Post
    ...
    It is not true that the injury site has not been studied deeply by any laboratory.
    ...
    Wise.
    Wise,

    actually I said that:

    "If there is one thing that disturbs me deeply in SCI research is the fact that the "lesion environment" (the scar) in chronic SCI hasn't been studied deeply by more labs yet"

    I think that is very different than saying that "the injury site has not been studied deeply by any laboratory"

    Hope it's more clear now what I wanted to say.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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