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Xoma Starts a Phase-II Human Trial

Discussion in 'Research' started by joshualevy, Nov 18, 2009.

  1. joshualevy

    joshualevy Approved members

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    My local JDRF chapter is setting up a "Research Information Committee" to help spread the word about type-1 diabetes research, and I was asked to be a member. We had our first meeting a few days ago, and one of the other members mentioned the following human trial was just getting started:

    Xoma Starts a Phase-II Human Trial

    Xoma is starting a phase-II clinical trial of their "Xoma 052" drug.

    The study is placebo controlled and double blind, and the primary end-point is C-peptide levels (so good design). It is being done in Zurich and I'm not sure how many people will be enrolled. Only people who have had type-1 diabetes for 2 years or longer will be enrolled. So this is not a honeymoon study: quite the opposite; honeymoon diabetics are excluded.

    There are already two separate phase-I clinical trials underway to see if Xoma 052 improves type-2 diabetes. (I assume that is why they could go directly to phase-II trials in type-1 diabetes: the basic safety was already established.) Xoma inc. is also doing animal research to see if this drug can be used for many other inflammation related diseases, such as rheumatoid arthritis and gout.

    This clinical trial is being funded by JDRF.

    Xoma 052 is a monoclonal antibody which is a broad anti-inflammatory, and works by blocking the IL-1 inflammation pathway. Xoma is in the business of developing monoclonal antibodies which are then marketed by much larger companies. They already have a couple of drugs on the market.

    Discussion

    Earlier this year (and in 2008) there was some excitement about inflammation based treatments as cures for type-1 diabetes. The idea as that the body's autoimmune response triggered inflammation and it was the inflammation which actually killed the beta cells. So lowering inflammation could cure or prevent type-1 diabetes. This is a minority opinion, to be sure. Most researchers believe that inflammation is a side effect of the beta cells being destroyed, not a cause of their destruction. This trial is the third one, that I know of, based on the idea that anti-inflammatories can cure type-1 diabetes.

    One of the best things about this research, is that they expect results next year, and as a phase-II trial, it should be big enough, so that the results should be pretty clear as to the basic success of the drug. We should have a basic "thumbs up / thumbs down" result by the end of 2010. Another good thing, from my point of view, is that this is not a honeymoon only treatment or trial.

    Personally, I'm a little dubious about the whole "anti-inflammation as a cure" path. But I'm also very data-driven, and we now have 3 different studies going on to try to cure type-1 using this path. If any one of those studies gives successful results, then all my doubts will be erased. :)


    Xoma's press release:
    http://www.xoma.com/company/news-events/press-releases/index.cfm?releaseID=421746
    Clinical trials record for this research:
    http://www.clinicaltrials.gov/ct2/show/NCT00998699
    Clinical trials records for Xoma's other diabetes research:
    http://www.clinicaltrials.gov/ct2/results?term=xoma+diabetes
    Previous blog entry on inflammation (including some general discussion):
    http://cureresearch4type1diabetes.blogspot.com/2009/04/two-new-trials-to-test-kineret-anakinra.html

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.
     
  2. Toni

    Toni Banned

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    Thanks, Joshua, for keeping us updated. I hope this is not a longshot and successful
     
  3. Ellen

    Ellen Senior Member

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    Joshua, I think there's a huge role for keeping IL-1 beta, and other inflammatory markers, down for prevention of type 1 - perhaps in persons found to be antibody positive who have not converted. Of course I'd rather it was done using things like omega 3 etc., etc.
     
  4. joshualevy

    joshualevy Approved members

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    It is an interesting question: do you have any idea how much omega-3s and similar dietary components effect IL-1 inflammation, compared to how much an anti-inflammatory drug effects it?

    I've always assumed that diet changes had a very small effect compared to drugs, but would be interested in any data that you had. There's no question that dietary components are safer.

    Joshua Levy
     
  5. Ellen

    Ellen Senior Member

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    I'm looking forward to the data from the continuation of the pilot (below)
    http://www.clinicaltrials.gov/ct2/show/NCT00333554?term=omega+3+diabetes&rank=9

    Do you have full text access to this? Otherwise I can email it to you.

    Nutritional Intervention to Prevent (NIP) Type 1 Diabetes A Pilot Trial


    ICAN: Infant, Child, & Adolescent Nutrition
    2009; 1; 98
    Adams, Jay S. Skyler, Michael Clare-Salzler and , and the Type 1 Diabetes TrialNet NIP Study Group
    H. Peter Chase, Ellen Lescheck, Lisa Rafkin-Mervis, Heidi Krause-Steinrauf, Sonia Chritton, Smita M. Asare, Sara

    http://can.sagepub.com/cgi/content/abstract/1/2/98


    (And, IMHO, important anectdotal from the son of one of the author's above:
    http://www.childrenwithdiabetes.com/d_0c_1kc.htm )

     
    Last edited: Nov 23, 2009
  6. millyyates

    millyyates Approved members

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    This is a classic example why I think Joshua Levy is a drug company rep. Research has been done for example on Type 2 diabetes that shows that diet and exercise is many times more effective than drugs in managing the condition. I would be interested in any data that showed that Joshua is not a drug company rep.
     
  7. Pavlos

    Pavlos Approved members

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    Milly please do not make such unfounded allegations, they do not reflect well on you ...
     
  8. millyyates

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    I have said before about my view of the unsupported views of Joshua and there worth.


    He makes unsupported statements like his views on research are worth listening to.

    eg "So lowering inflammation could cure or prevent type-1 diabetes. This is a minority opinion, to be sure. Most researchers believe that inflammation is a side effect of the beta cells being destroyed, not a cause of their destruction. This trial is the third one, that I know of, based on the idea that anti-inflammatories can cure type-1 diabetes."

    This guy is so full of self opininated unsupported rubbish that it has turned me off the research pages of this great website. What qualifications does he have to give opinions on what researchers think or the possible effectiveness of one drug over another.
     
  9. StillTypeI

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    Milly, if you don't like Joshua's posts, then DON'T READ THEM. It is as simple as that!
     
  10. Toni

    Toni Banned

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    Thank you, Joshua! Time for another visit to your excellent and informative site.

    This type of statement is rude and certainly you are making accusations based on nothing more than speculation. I, for one, find Joshua's site informative, with numerous links to studies to aid in a parent's research. Could save a parent a heck of a lot of time. He is free, like others, to give his personal opinion of a treatment. Yes, a DRUG will most likely be involved in a cure for Type 1 diabetes, imagine that! Parents investigating drugs to extend the honeymoon in a newly diagnosed child have a very short window of time in which to work. Our endo is doing research on the Rutuximab which has been disparaged on this site. You bet, if E were in the honeymoon stage, we would investigate that drug and others to buy her five more years of good glycemic control. We are extremely interested in Faustman's work (which will not cure all or even most Type 1 diabetics) or ANY research that has a good potential for a cure. In fact, we hope to have DN enrolled in a study at her diabetes center if she proves a candidate. Don't want to wait 20 more years. I believe Joshua does have some ties to JDRF, I might be wrong?
     
  11. buggle

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  12. joshualevy

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    Just to expand on that comment for a second:

    It is my goal to own stock in every company that is doing clinical trials into a cure for type-1 diabetes. I'm not there yet, but I view that as a way to support clinical trials and a way to "put my money where my mouth is" so to speak. For example, I own stock in both LCT and Diamyd. In the next year, I hope to buy some Xoma stock. I wish I could buy stock in Bayhills, but they are not publicly traded. And so on. Unfortunately, you can't really buy stock in a university research program.

    Buying stock in a company increases that company's valuation, which can help them use their stock to finance purchases, etc. and also makes them more valuable if they are bought out by another company.

    Obviously, giving money to organizations which fund cure research is key to creating a cure, but I view buying stock in companies that do cure research as another step on the ladder that will eventually lead to a cure.

    Joshua Levy
     
  13. joshualevy

    joshualevy Approved members

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    Just last November (2009) I was asked to volunteer for my local JDRF chapter by becoming a member of their "Research Information Committee". I'm very happy and honored to be part of that work. So far, we've only had a few informational meetings, but I'm looking forward to helping to make JDRF more transparent. (I'm often amazed that some people think JDRF is not funding a particular line of research, when in fact it is, or the opposite: people think JDRF puts huge amounts of money into something when in fact it is only 1% or 3% going to that area of research.) I'm hoping to help make it easy for anyone to find out what JDRF is doing (and not doing) and why.

    Obviously, all my posts here are my own personal opinions (unless I specifically say otherwise). And my blog and web page cover ALL human trials, not just those funded by JDRF.

    Joshua Levy
     
  14. chbarnes

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    I appreciate Joshua keeping us up to date on these trials. It's not his fault that the overwhelming majority of clinical research studies are funded by the pharmaceutical industry. It is also not the responsibility of private businesses to fund research that doesn't result in a marketable product. Nevertheless, there is much to be learned about clinical care that doesn't use a new product. This isn't only true of diabetes. Groups like the JDRF can do a certain amount of good, but government has to do more to define best practices and find new and novel uses for existing drugs. One could argue that health insurers could fund this type of work, but the horizon for return on investment is just too far for them to make a serious investment. So, if you want research that is not commercialized, you have to support an expanded role for government.

    Chuck
     
  15. jade

    jade Approved members

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  16. carbz

    carbz Banned

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    I hope you didn't purchase Microislet like I did. I bought it back in 07 I think for around $.90 a share and thought it was a bargain. So much for that as that was $2K down the drain. I also own transition therapeutics which at one time was nearly double of what I paid, now its worth less then half of what I paid. I really don't have the kind of money to be playing around in the market especially with high risk stocks but I have a small portfolio and figured why not invest in a potential diabetes treatment. As much as have no problem donating to worthy causes I don't have the disposition to loose hard earned money. I would buy stock in Smart Insulin if they were public. I see that therapy eventually panning out.
     
  17. Toni

    Toni Banned

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    Joshua, I did not discover your site until after DN was out of her honeymoon. Very unfortunate. Such a short window of opportunity and your site has links to a lot of research. Could save a parent a lot of time. I'm sure you put a lot of work into your site. Thank you.
     

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