Wednesday, November 18, 2009

Xoma Starts a Phase-II Human Trial

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.

4 comments:

Anonymous said...

Did you read about the accidental medical breakthrough with the Interleukin-1 beta (IL-1╬▓) gene and Alzheimer’s disease? XOMA is very secretive http://www.sciencedaily.com/releases/2009/10/091022114315.htm

Joshua Levy said...

I don't know what you mean by "very secretive". I got my information from a press release (very public). They filed the Clinicaltrials paperwork to start their trial on Oct-22, and discussed it publicly on Nov-4. I don't see how that is secretive at all.

Joshua Levy

Anonymous said...

Well...The scientific community was very skeptical that a Bacteria could be the causative agent of many cases of Petic Ulcer Disease i.e., Heliobacter pylori. The 'Scientific Community" went on to eat 'Crow" for that opinion and the researcher who hypothesized and later proved the connection went on to win the Nobel Prize in Medicine if I'm not mistaken. So inflammation in Type 1 diabetes? The Scientific Community has been proven wrong before.

Saul

Anonymous said...

In the past 15 years, innate immunity has come into its own. Inflammation, its hallmark characteristic, has gained recognition as an underlying contributor to virtually every chronic disease a list that, besides obvious culprits such as rheumatoid arthritis and Crohn’s disease, includes diabetes and depression, along with major killers such as heart disease and stroke. The possibility of a link with a third major killer cancer has received intensive scrutiny in this decade. The connection between inflammation and cancer has moved to center stage in the research arena, notes Robert A. Weinberg of the Massachusetts Institute of Technology’s Whitehead Institute for Biomedical Research, who has highlighted the changing emphasis in a revision of his leading textbook, The Biology of Cancer (Garland Science, 2006).

-- July 2007 issue of Scientific American