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.
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:
Clinical trials record for this research:
Clinical trials records for Xoma's other diabetes research:
Previous blog entry on inflammation (including some general discussion):
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.