By Pat Anson, PNN Editor
The start of a potentially groundbreaking study of a vaccine to treat fibromyalgia has been delayed because not enough men have volunteered to participate.
Massachusetts General Hospital and EpicGenetics – a Los Angeles-based biomedical company – received FDA approval last year to enroll 300 fibromyalgia patients in a placebo controlled Phase 2 study to see if the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. Volunteers must first test positive for fibromyalgia after taking a diagnostic blood test developed by EpicGenetics.
Half the volunteers will receive injections of the BCG vaccine every 12 months, while the other half will receive placebo injections. The 3-year study was initially projected to begin January first, but has yet to get underway.
“One of the problems we’re having is that the vast majority of the people who have taken the blood test are women aged 50 and above,” said Bruce Gillis, MD, the CEO and founder of EpicGenetics. “We really need more diversity. So we are pushing hard to find more men and more younger people to test.
“We’re still hoping to start this year. But we’re hoping for more diversity in the patients.”
Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, there is no cure and the symptoms are difficult to manage. Between 75 and 90 percent of the people who have fibromyalgia are women.
The BCG vaccine has been used for over 80 years to prevent tuberculosis and meningitis in children. Gillis believes the same vaccine can be used in adults to stimulate the immune system and reverse symptoms of fibromyalgia.
“When BCG has been administered in other chronic illnesses, it has triggered the immune system’s stem cells to change their behavior. And in our case, we believe that should allow for the production of healthier peripheral blood mono-nuclear cells -- the white blood cells that we find to be impacted in fibromyalgia,” Gillis told PNN.
“The expectation is that when the patient receives the BCG there is a stimulus to change stem cells and white blood cell production to produce healthier cells. And as a consequence, their fibromyalgia should be reversible.”
EpicGenetics’ FM/a blood test for fibromyalgia was first introduced in 2012 and is now covered by Medicare and most insurance companies. The cash cost for patients without insurance is $1,080. If the BCG vaccine proves effective, Gillis says the vaccine will be provided at no cost to patients who test positive for fibromyalgia.
Anyone interested in participating in the study at Massachusetts General Hospital should send an email to firstname.lastname@example.org.
“We need patients from age 18 to 80 plus. And we need more men. I don’t think I’ll ever get an equivalent number of men as I will women, but I need more than just a handful of men,” says Gillis.