EpicGenetics and Massachusetts General Hospital to launch fibromyalgia clinical trial

The FM/a Test, a clinical diagnostic blood test which is performed by Los Angeles-based EpicGenetics, has been approved for use by the U.S. Food and Drug Administration (FDA). And now, EpicGenetics and Massachusetts General Hospital (MGH) are launching a Phase II clinical trial to test a tuberculosis vaccine, BCG, as a potential treatment for fibromyalgia.
The structure of the clinical trial is to enroll 300 patients who test positive for fibromyalgia with the FM/a Test. They will be split into two groups, one receiving the vaccine, the other receiving a placebo.
“Currently,” says Bruce Gillis, CEO of EpicGenetics, “the only objective way to get fibromyalgia confirmed is by having the test. We’re in the process of contacting the people who had the test and seeing if they want to participate. We’re encouraging other people who want to potentially volunteer to also get the test, so we can do this. The expectation is that if the results are as good as we hope, potentially in as little as six months, we will have further opportunity to expand the treatment to many, many more people as we collect the data. We don’t expect significant side effects and we expect fairly rapid responses to the BCG by the people who participate in the trial who receive it.”
Read the full article: EpicGenetics and Massachusetts General Hospital to Launch Fibromyalgia Clinical Trial (BioSpace)