BCG Vaccine: new Sjogren’s Syndrome trial and possible delays

It’s been a while since my last post. Unfortunately, I spent much of March sick, first with a bout of flu, then a nasty sinus infection that migrated to my chest. Between the two, my immune system took a real beating.

On to some (delayed) news! Past readers may recall my post last year discussing Dr. Denise Faustman’s lab, which had begun a phase 2 trial for diabetes treatment using the BCG vaccine. I was excited for this trial, because Faustman had previously researched treatments for SS, and mouse models had demonstrated that BCG could treat SS as well as diabetes.

Thanks to a forum post, I was alerted to the fact that a trial is planned for SS and BCG! I verified that this information appeared in the Winter 2015 edition of Sjogren’s Quarterly, a reputable journal:

This vaccine already has a 95-year safety profile due to its use worldwide for TB and at very high dose for bladder cancer. BCG induces TNF, a cytokine that promotes Treg generation and death of autoreactive T cells. Ongoing Phase III trials are taking place in Multiple Sclerosis (MS) in Italy, Phase II type 1 diabetes in Boston, Massachusetts and Phase II prevention trials in Denmark, Australia, and Turkey. Phase I trials in Sjögren’s are in the planning stages at the NIH.

Unfortunately, it seems that these trials may be running into some FDA hiccups. First, an email alerted me to this post, which notes that the FDA-required methodology for the diabetes trial may make success difficult:

As we have seen, the methodology is crucial and a strong determinant of success of any trial that aims to reverse a disease. explored the core of ideal methodology which is to modulate the dosages and the frequencies of one compound depending of on direct/indirect biomarkers linked to disease up to maximum individual subject tolerance… Moreover, we showed Dr Faustman’s current phase II FDA approved methodology is far from an ideal methodology that could avoid wasting money and time. The methodology imposed by the FDA doesn’t permit the basic elements of ideal methodology.

I have no way to verify this, as I am not connected to Dr. Faustman or her lab. I’m also not a medical doctor or researcher, but to my amateur eyes it seems reasonable. Hopefully the kinks will be ironed out, leading to a successful trial.

A regular reader has also told me that their rheumatologist reports delays in the diabetes trial, and thus the SS trial as well. I do not know if this is related to any of the methodology issues outlined above. As the Sjogren’s Quarterly article does not give an actual start date for a SS trial, any delay is purely internal at this point.

Still, despite possible setbacks, this is exciting news!

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