FDA Approves Clinical Trial of Tuberculosis Vaccine for Fibromyalgia

EpicGenetics announced on9/5/18 that the U.S. Food and Drug Administration (FDA) has given approval to the Massachusetts General Hospital for a human clinical trial of BCG (an inexpensive generic vaccine used globally to prevent tuberculosis) to treat fibromyalgia.

The trial is being funded by a philanthropic gift from Bruce Gillis, M.D., an advocate for fibromyalgia patients since he and his research team at the University of Illinois, College of Medicine at Chicago discovered unique immune system, cellular and protein abnormalities which are associated with the disease of fibromyalgia. Global research concerning the BCG vaccine, such as the research work of Dr. Hazel Dockrell at the London School of Hygiene and Tropical Medicine has demonstrated that vaccinations with BCG can activate immune markers which are known to be the same reciprocal defects within the immune systems of people 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 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 Dr. Gillis. "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."

Fibromyalgia is a debilitating disease that causes substantial pain, chronic fatigue and depression among other symptoms. Patients also incur significant expenses and lost wages. It is a leading cause of disability. There are literally millions of individuals, ranging from pediatric to geriatric ages, who will be candidates to have their fibromyalgia confirmed and then become eligible for this treatment trial. According to the National Fibromyalgia Association approximately 10 million people in the US alone are affected by the disorder.

Disclosure: Dr. Gillis is also the CEO of EpicGenetics. EpicGenetics, Inc. is a privately held biomedical company based in Los Angeles, California, that develops and manufactures an approved fibromyalgia test that tracks the immune defects of this disease, the FM/a Test. EpicGenetics is dedicated to improving the diagnosis and treatment of fibromyalgia and by investing in and developing further comprehensive clinical studies at leading medical research centers through unrestricted donations.