Wednesday, August 19, 2015

Research In The News (August)

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:
http://cureresearch4type1diabetes.blogspot.com/2014/05/secukinumab-and-ustekinumab-each-start.html

Reporting: http://webcache.googleusercontent.com/search?q=cache:-Iu_s9VcSmwJ:adisinsight.springer.com/drugs/800023920+&cd=1&hl=en&ct=clnk&gl=us
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:
http://cureresearch4type1diabetes.blogspot.com/2014/04/dr-faustman-starts-phase-ii-trial-for.html
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

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.

1 comment:

Brian White said...

Thank you so much for the updates. It is not easy to find and compile all of the information in a meaningful way, but you do a great job at it! Keep up the good work.