Researchers from the Massachusetts General Hospital recently received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase II clinical trial to test a generic vaccine’s ability to reverse advanced Type 1 diabetes.
The study will soon begin to enroll qualified patients and will last five years. The purpose of the trial is to determine whether repeat bacillus Calmette-Guerin (BCG) vaccinations can improve Type 1 diabetes in the age range of 18 to 60 years old. These individuals must have small but detectable insulin secretion levels.
The approval of the trial for the vaccine, a BCG vaccine, was announced by Denise Faustman, the director of the hospital's immunobiology laboratory and lead investigator of the study at the 75th Scientific Sessions of the American Diabetes Association.
"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," Faustman said. "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."
"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," Faustman, an associate professor of medicine at Harvard Medical School, said.
The study will work with with people who have had Type 1 diabetes for many years to create a regimen that will treat even advanced disease. In addition to the phase I trial, Faustman's team will take guidance from the BCG clinical trials that are underway globally for other autoimmune diseases, such as multiple sclerosis.
"My family and I have been fortunate to be part of this research for many years. It is incredibly exciting to be talking about curing people, not mice,” Lee Iacocca, founder of the Iacocca Foundation, said. “I made a promise to my late wife to find a cure for Type 1 diabetes. Now my family and I look forward to the continued progress and are proud to support this effort to get closer to that goal."