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FDA Approves Clinical Trial for Fibromyalgia Using TB Vaccine

The repurposing of BCG could have huge implications for future therapy

A PPM Brief

EpicGenetics (Los Angeles, CA) announced the FDA approval to the Massachusetts General Hospital1 for a human clinical trial of the bacillus Calmette-Guerin (BCG) vaccine to treat fibromyalgia, sponsored by the company. The BCG vaccine has been known to boost production of the cytokine tumor necrosis factor, which can aid autoimmune diseases by eliminating the autoreactive T cells and by inducing production of regulatory T cells that could prevent an autoimmune reaction.2 Previous research3 on the vaccine has demonstrated that BCG can activate immune markers known to be the same reciprocal defects within the immune systems of those with fibromyalgia.

(Source: 123RF)

"This trial has the potential to impact the biology of fibromyalgia, and now with clinical testing, it will be determined over the next four years whether this vaccine has clinical validity as well. Since the generic BCG vaccine is affordable and safe, the clinical trial introduction of this vaccine will perhaps transform the lives of the patients who currently have no other direct treatments available to combat this very debilitating disease," said Bruce Gillis, MD, MPH, founder of EpicGenetics.

Dr. Gillis continued, “The FDA will be looking at indicators to determine if BCG is having a clinical effect with a decrease in pain for fibromyalgia patients and an increase in overall function in the standardized testing for this disease. If the results are promising, we anticipate being able to rapidly expand the BCG treatment to many more patients due to its long-standing safety.”

Last updated on: October 5, 2018
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