Market Overview

FDA Approves Clinical Trial of Novel Treatment for Fibromyalgia


The trial will analyze the impact of bacillus Calmette-Guerin (BCG)
on the disease

Today EpicGenetics announced 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.

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. More information is available at

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