Another exciting clinical trial (BCG vaccine)

This trial is of personal interest to me. Back in 2013, my early research had led to to the lab of Dr. Denise Faustman. Dr. Faustman has been pushing her theory that an old tuberculosis vaccine can treat and possibly reverse type 1 diabetes. A small phase 1 clinical trial a few years ago provided enough support for the theory to drive Dr. Faustman to raise nearly $20 million from donations for a phase 2 trial. Finally, that trial is about to begin:

“In the phase I (preliminary) trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) is to create a lasting therapeutic response,” Faustman said in a statement. “We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease.”

The BCG vaccine was first used in humans in 1921 as a vaccine against tuberculosis. More recently, its most common use in the U.S. has been in the treatment of bladder cancer.

“It’s a drug with an impeccable safety record,” Faustman said, noting that it has more than 90 years of clinical use and safety data.

It should be noted that Faustman has her critics among diabetes experts, who don’t believe that a vaccine nearly a century old can have a significant effect on the course of the disease. On Faustman’s side is another trial that demonstrated the BCG vaccine could halt the progression of multiple sclerosis. As no pharmaceutical company stands to gain money off of a publicly available vaccine, this trial will be a make-or-break moment for the treatment.

So why am I so excited? I have Sjogren’s syndrome, not diabetes. Well, Dr. Faustman has previously done research addressing Sjogren’s syndrome. In particular, she was a collaborator on “Reversal of Sjögren’s‐like syndrome in non‐obese diabetic mice,” along with several other SS-related papers you can see on her lab’s research page. Diabetes and Sjogren’s share many traits, and her protocol has already been tested on a SS mouse model. From the Faustman Lab FAQ:

Independent work by Tran et al.4 confirms our findings that the spleen can contribute to the regeneration of the pancreas. Tran’s group evaluated our protocol to see if it would be effective in diabetic mice that also had Sjögren’s syndrome, an autoimmune disease affecting the body’s moisture-producing glands. The researchers found that our protocol could be used to reverse both type 1 diabetes and Sjögren’s syndrome in mice, with a success rate of diabetes reversal close to 100%, and that the spleen did contribute in part to regeneration of the pancreas and the salivary glands.

If the clinical trial for diabetes proves successful, it could very well mean a cheap, widely available SS treatment with a reliable 90-year safety profile. I for one am hopeful.

Dr. Faustman

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