Sunday, August 16, 2009

Brod Completes Phase-II trial of Alpha Interferon

Brod has finished a Phase-II clinical trial of oral interferon alpha, as a possible honeymoon cure of type-1 diabetes, and has published the results. The study involved 128 people, some of whom got 5k units of interferon, others got 30k, and others got none at all; daily doses for one year. After a year, natural insulin production in response to a meal was measured. The experiment was random assignment and double blind.

The results were this: The untreated group lost 56% of their insulin production one year after diagnosis. The group treated with 30k lost 46% but the group treated with 5k lost only 29%. So the best-to-worst summary is that the treated group lost about half as much insulin production as the untreated group. This result is very similar to Diamyd's and ToleRx's Phase-II results.

The press release describes Brod's theory this way:
Brod's theory is that autoimmune diseases, which occur when the body is attacked by its own immune system, are actually an alpha interferon immunodeficiency syndrome. Interferons are a group of proteins produced by cells in response to an attack by a virus.
My translation of this, is that he thinks that type-1 (and other autoimmune diseases) are caused by a lack of alpha interferon. Therefore, dosing with alpha interferon is an obvious path to a cure.

This clinical trial was funded by Diabetes Action Research and Education Foundation, the US Gov and the Children's Hospital of Minnesota Foundation.

Press release is here:
http://www.sciencedaily.com/releases/2009/07/090701083049.htm

Abstract of the results is here:
http://www.ncbi.nlm.nih.gov/pubmed/19564474?dopt=Abstract

Clinical Trial Record is here:
http://www.clinicaltrials.gov/ct2/show/NCT00024518
(By the way: this is one of the worst clinical trial records I've seen. Especially since the US Gov is a major contributor to this work. There is no end date, Brod is not listed as primary investigator, no description of how many patients got which treatment, etc.)
There is also another clinical trial record here, but I'm not sure if this is the same clinical trial, a related one, or a totally different one:
http://www.clinicaltrials.gov/ct2/show/NCT00005665

Joshua Levy

1 comment:

pedro said...

I am actually in the tolerx phase III trial of otelixizumab and it is working quite well for me. I have stopped using Novolog and just use Lantus. I have cut my total units that I take a day in about half, I am currently about one month after the drug (or possibly placebo) dosing.
Actually, I am really using less than half because before I was dosed I was really careful of my carbohydrate consumption but now I eat much more than I was previously and my blood glucose numbers are still vastly improved. Well, another couple years in the study, hopefully this will continue to work. Wish me and all the others luck. Maybe we will have a cure or at least a good treatment soon for others with type I.