FDA approves BCG vaccine trial for reversing Type I diabetes in phase II tests

The director of the Massachusetts General Hospital Immunology Laboratory, Dr. Denise Faustman at the 75th Scientific Sessions of the American Diabetes Association (ADA) on Sunday announced that the US Food and Drug Administration (FDA) has approved a phase II trial for reversing Type I diabetes using BCG vaccine shots.

Dr. Faustman is also an associate professor of Medicine at Harvard Medical School and the lead author of the study, stating that a 5-year trial will commence soon where clinical investigators will evaluate the efficacy of BCG vaccinations for improving the health status of diabetic patients, especially those aged 18-60 and still able to release moderate amounts of insulin via their pancreas.

According to Faustman, “We have learned a lot since the early studies in mice – not just about how BCG works but also about its potential therapeutic benefits, similar to what are being seen in trials against other autoimmune diseases.”

And then he added that “We are so grateful to all of the donors, large and small, who have made this trial possible – especially the Iacocca Foundation, which has believed in us and has been a supporter since our early days. Our goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year.”

The research team looks forward to raise about $25 million for the research project, and through the intervention of Iococca Family Foundation and others has been able to raise $19 million.

The researchers conducted phase I trial in 2012 and published their findings back then in the journal PLOS Medicine, a study which showed that BCG shots given at intervals of four weeks could destroy T cells fueling diabetic conditions, thereby helping the body to start producing insulin all over again.

“In the phase I clinical trial we demonstrated a statistically significant response to BCG, but our goal in phase II is to create a lasting therapeutic response,” the researchers said.

“We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease. In addition to our phase I trial, we took guidance from the BCG clinical trials that are underway globally for other autoimmune diseases such as multiple sclerosis.”