Called DILD1T, this is a 40 person clinical trial. It started in March 2013, and is expected to finish in January 2015. It is enrolling adults who have had type-1 diabetes for 3-24 months (so not just honeymooners) in Addenbrooke’s Hospital, Cambridge, UK. Currently, it is only 12% enrolled, so they have a ways to go. I'm treating this as a phase-II trial, because of it's size and because Proleukin has already been tested twice in type-1 diabetics (that I know of).
I think that this study involves only one subcutaneous injection (like an insulin injection).
Here is the justification for the study. The quote is from the researchers, but I've removed some of the medical language:
The vast majority of genes that contribute to susceptibility to type 1 diabetes [are related to] immune regulation and function. In particular, ... the interleukin 2 (IL-2) pathway that regulates T cell activation .... Aldesleukin (Proleukin) is a human recombinant IL-2 product .... There is substantial [research data in tissues/petri dishes, animals, and humans] that ultra low dose IL-2 (aldesleukin) therapy can arrest the autoimmune mediated destruction of pancreatic beta cells by [encouraging] functional T regulatory cells.The researchers view this study as looking for the optimal dose as a prelude to doing a large phase-III trial. This is a classic goal of many phase-II trials. This trial is funded by the Welcome Trust (a big UK operation), JDRF, and the NHS Foundation Trust (which I think is the UK government).
Here are links for this new research:
Web sites: http://www.clinical-trials-type1-diabetes.com http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13846
WHO Registration: http://www.controlled-trials.com/ISRCTN27852285/
US Registration: http://www.clinicaltrials.gov/ct2/show/NCT01827735
Wikipedia on IL-2: http://en.wikipedia.org/wiki/Interleukin_2
I also think it is important to remember that IL-2 has been tested in humans twice before, and has failed both times. I previously blogged on those trials:
Clinical Trial Records:
DiaPep 277's Results from an Extended Phase-III Trial:
No Longer a Cure?
I've been following DiaPep 277 for as long as I've been following type-1 diabetes cures. When I started, it was already in phase-II trials. Recently Andromeda Biotech Ltd, the company developing it, has published some phase-III results, and (most recently) some extended phase-III results. These extended results are from people who were in the phase-III trial for two years, and then continued with the treatment for an additional two years. The two year extension was "open label", meaning that the patients and doctors knew they were getting the treatment; it was not blinded.
Unfortunately, the results are decidedly mild. People's A1C numbers dropped by 0.6 (from an average of 7.6 to an average of 7.0. In terms of improvement of treatment, that's not bad. I think there is a market for a drug that would lower A1C numbers that amount, but it is not a cure. There is always hope that future improvements in the treatment will lead to even better A1C improvements (which I think is likely), or even improvements so great they lead to a cure (which I think is very unlikely). But currently, this is an adjunct treatment, not a cure. So I expect to stop covering DiaPep 277, unless I see results much larger than are seen here.
The previously announced results from one of their phase-III trials, which I blogged about here:
were similarly mild, and much more like a treatment than like a cure.
Phase-I Trial Resets the Immune System in MS Patients
This news comes from a human trial in multiple sclerosis (MS) patients. Basically, researchers were able to "reset" the body's immune system, to lower the autoimmunity reaction (the body's attacking it's own cells) by 50%.-75%. This was in a 9 person phase-I trial in Germany.
To understand why that is important, a little background is needed. Most researchers believe that MS and Type-1 are related diseases. In both cases the immune system mistakenly attacks the body's own cells. In Type-1, it attacks beta cells in the pancreas, and in MS it attacks the myelin sheaths of nerve cells, however the underlying autoimmunity reaction is similar.
Prior to testing on people, this method was tested in mice who had MS and in mice who had type-1 diabetes, and worked on both groups of mice. However, the human trials were MS only. But obviously, trials in type-1 diabetic people could be done as well. In my opinion, should be done.
The idea of resetting (or rebooting) the body's immune system has been tried on type-1 diabetics, and it was successful. Some of the treated type-1 diabetics did not have to inject insulin for years afterwards. However, the risk involved is high enough, that these treatments have never moved forward. At least three different teams (in Brazil, Poland, and China) have run similar trials and gotten similar results. I have blogged about them before:
Although it is hard to draw a direct comparison, it sounds like the procedure being tested here is much safer, but slightly less effective than the procedure used by Burt, Snarski, Li, etc. Of course, it might be refined over time to make it more effective or safer, or both.
In the past, I've posted on my blog what I call a "non-conflict of interest statement" which is this:
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/