This blog posting contains bits and pieces of news on type-1 diabetes research aimed at a cure.
The Phase-II Trial of Secukinumab Was Terminated
The phase-II clinical trial of Secukinumab was canceled in June 2014. I have not seen any public notification about why it was canceled. Apparently five people were dosed before it stopped, but I have no idea if any results will be published or not. This trial was being run by Novartis.
You can read my previous blogging on this trial here:
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02044848
Phase-II Trial of BCG By Faustman Starts Recruiting
I made a big announcement when Dr. Faustman announced she was ready to start her phase-II trial. However it took over a year to actually start recruiting patients. The blog I wrote previously is still accurate (except as described below), so If you want to know what is going on with BCG, I'd start out by reading my previous blog:
and then consider the following updates in the last year:
First the good news: it will include 150 patients, rather than 120 as before.
Second, the bad news: the delay means the study will complete in 2023 rather than 2022 as before (which means publication in 2024 is a reasonable goal).
Third, a change in primary outcome. The study as I read it now, is going to have A1c measurement as it's primary end point, and C-peptide measurement as a secondary end point. Previously, I had thought that both would be primary end points, but I might have just misread the clinical trial registration.
However, no matter which is primary and which is secondary, the important end point is the C-peptide numbers, not the A1c numbers. For cure research, C-peptide is a much better measure of success than A1c. C-peptide is what the FDA requires for cures, and that is what measures how much insulin your body is creating itself. A1c, on the other hand, is a good measure for type-1 treatments. So in this case, in 2024, when we are looking at the results, it will be the C-peptide results that matter.
I don't see that there are any other major changes from a year ago: no change to dosing regimen and no change to duration.
Press Release: http://www.eurekalert.org/pub_releases/2015-06/mgh-mgh060315.phpClinical Trials Record: http://clinicaltrials.gov/ct2/show/NCT02081326
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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.