Trial Evaluating BCG Vaccine for Fibromyalgia Given Green Light by FDA

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Approval was specifically granted to Massachusetts General Hospital to conduct the trial.
Approval was specifically granted to Massachusetts General Hospital to conduct the trial.

The Food and Drug Administration (FDA) has given approval for a human clinical trial of the bacillus Calmette-Guerin (BCG) vaccine as a potential treatment for fibromyalgia

EpicGenetics, a privately held biomedical company, is sponsoring the trial; approval was specifically granted to Massachusetts General Hospital. Previous research suggests that the BCG vaccine can activate immune markers which may potentially benefit patients with fibromyalgia; the investigators hope that the vaccine can increase anti-inflammatory cytokines, which are deficient in patients with fibromyalgia.

"This trial has the potential to impact the biology of fibromyalgia and now with clinical testing it will be determined over the next 4 years whether this vaccine has clinical validity as well," said Bruce Gillis, MD, and CEO of EpicGenetics. "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."

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