Current Research into Cures for Type-1 Diabetes: August 2016

Sunday, August 28, 2016

Ladarixin Starts a Phase-II? Clinical Trial

You'll notice that the title of this blog refers to a "Phase-II?" trial, rather than the more usual "Phase-II" trial. That's because I'm experimenting with new terminology.

Researchers usually call a trial "Phase-II" because it is larger than a Phase-I trial, and because it is focused on effectiveness while Phase-I trials are focused on safety. However, I have long been frustrated by two different types of Phase-II trials. Some Phase-II trials are run after a Phase-I trial. Generally, there was good news from the Phase-I trial, so it is reasonable to be hopeful about the follow on trial. However, other Phase-II trials are run on drugs which have already gone through safety testing for another disease. These trials are also called "Phase-II" because the treatment has already been tested for safety. However these treatments have never been tested for type-1 diabetes, so they are much less likely to be successful.

So there are Phase-II trials for treatments that have already shown some success in Phase-I trials, and then there are Phase-II trials for treatments which have never been tested on type-1 diabetes, but they both have the same name. I don't like that. So, I'm going to refer to these trials by different names.

Trials run after a Phase-I trial will be called Phase-II. Trials that are the right size for a Phase-II trial, but are being run on people with type-1 diabetes for the first time, will be called Phase-II? trials. You can think of the question mark as meaning "no previous type-1 results".

Ladarixin Starts a Phase-II? Clinical Trial

Ladarixin targets two specific immune system chemicals: IL-8a and IL-8b. The idea behind this trial is that suppressing this part of the immune system will stop the autoimmune attack which causes type-1 diabetes.

Ladarixin has previously been tested for several conditions unrelated to type-1 diabetes (Bullous Pemphigoid, Malignant Melanoma, and spinal cord injuries) but did not show promise in treating any of them. Adis Insight (a drug database) claims that a phase-I trial is underway in Italy, but I cannot find any official record of it, nor any results. (But European clinical trial registries often don't include Phase-I trials.) So for this posting, I'm assuming there is no phase-I trial. I'll update it if I find out about such a trial.

Ladarixin is also sometimes known as DF-2156A, DF-2156Y, or Meraxin. It is being developed by the Italian pharmaceutical company Dompé Farmaceutici.

The Study

The study will include 72 honeymooners (within 100 days of diagnosis). Two thirds will get the treatment and one third will get a placebo. The treatment is a daily pill, which people will take for two weeks, and then two weeks off with the cycle repeating three times. People will be followed for a year afterwards. The study started in June 2016 and they hope to finish by November 2018.

They are currently recruiting in two location in Italy:

Internal Medicine - Diabetes and Endocrinology Unit, San Raffaele Hospital Milan
Contact: Emanuele BOSI, MD bosi.emanuele@hsr.it
Unità Operativa Complessa di Endocrinologia e Dialettologia. Università Campus Bio-Medico di Roma
Contact: Paolo POZZILLI, MD p.pozzilli@unicampus.it

They hope to start recruiting in Belgium and more sites in Italy.

Discussion

Needless to say, Ladarixin prevents and cures type-1 diabetes in mice, and you can read that study here: http://diabetes.diabetesjournals.org/content/early/2014/10/06/db14-0443

I'm not aware of any previous work suggesting that IL-8 is involved in type-1 diabetes, so this is a unique line of research.

Note that both trial registry entries refer to the same trial:
US Clincal Trial Registry: https://clinicaltrials.gov/ct2/show/NCT02814838
EU Clinical Trial Registry: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-003968-20
Company: http://www.dompe.com/

Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
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, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

Friday, August 5, 2016

Atorvastatin (Lipitor) Unsuccessfully Completes a second Phase-II Trial

Atrovastatin (much better known as Lipitor) has now finished it's second phase-II trial. The previous trial was unsuccessful, and this trial is unsuccessful, so I think that Lipitor is probably done as a potential cure for type-1 diabetes. You can read my previous blogging here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Atorvastatin

This clinical trial started recruiting patients in July 2007, finished collecting data in July 2011, and finished completely in July 2013. It's now been 3 years since that date, and I cannot find a publication reporting on the results of this trial. In my experience trials with successful results are usually published within a year of completion, while those which are unsuccessful often languish for years, unpublished.

Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT00529191

The previous Lipitor paper is here:
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0017554
Conclusion from this previous paper:

Atorvastatin treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study.

Discussion

The problem of researchers not publishing results from unsuccessful clinical trials has been getting some press recently. For example:

Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:
1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.
2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)
Obviously, this is my personal definition of a cure; yours may differ.
Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).
I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.
I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.
None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)
My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.
I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.
In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.