
Mass. General Hospital launches phase II trial of BCG vaccine to reverse type 1 diabetes
Mass. General Hospital launches phase II trial of BCG vaccine to reverse type 1 diabetes
FDA approval of trial testing generic vaccine announced at ADA Scientific Sessions
A phase II clinical trial testing the ability of the generic vaccine bacillus Calmette-Gurin (BCG) to reverse advanced type 1 diabetes has received approval from the U.S. Food and Drug Administration (FDA). The approval of this trial, which will shortly begin enrolling qualified patients, was announced today at the 75th Scientific Sessions of the American Diabetes Association (ADA) by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory and principal investigator of the study.
The five-year trial will investigate whether repeat BCG vaccination can clinically improve type 1 diabetes in adults between 18 and 60 years of age who have small but still detectable levels of insulin secretion from the pancreas. Faustmans research team was the first group to document reversal of advanced type 1 diabetes in mice and subsequently completed a successful phase I human clinical trial of BCG vaccination. She announced the FDA approval to launch the phase II trial during her ADA presentation, Low Levels of C-Peptide Have Clinical Significance for Established Type 1 Diabetes.
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, says Faustman. We are so grateful to all of the donors, large and small, who have ma
Continue
reading