The generic vaccine baccilus Calmette-Guerin (BCG), which the NY Daily notes is an almost century-old vaccine used in the prevention of tuberculosis, has received the U.S. Food and Drug Administration’s (FDA) approval to begin phase II clinical trial testing the ability of the vaccine to reverse advanced type 1 diabetes.
The approval of the five-year trial was announced by Dr. Denise Faustman, MD, PhD, on Sunday at the 75th Scientific Sessions of the American Diabetes Association (ADA). Faustman is the director of the Massachusetts General Hospital Immunobiology Laboratory as well as the principal investigator of the study and an associate professor of Medicine at Harvard Medical School.
During the five-year trial, researchers will investigate the ability of BCG vaccinations to clinically improve type 1 diabetes in adults between the ages of 18 and 60 who have small but detectable levels of insulin secreting from their pancreases.
Dr. Faustman was quoted in a public release on EurekAlert as having said that their “goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year.”
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 (…) 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.
As for funding, the study has secured $19 million of the $25 million total it requires to conduct the study. According to the NY Daily News, much of the $19 million secured has come from the Iacocca Family Foundation which funds research into type 1 diabetes.
The phase I clinical trial, which was published back in August of 2012 in the journal PLOS Medicine, found that a couple of BCG injections spaced four weeks apart to temporary eliminate the diabetes-causing T cells. The study also found evidence of a small transient return of insulin secretion.
The new trial, which is to be conducted as a double blind at MGH, will include 150 adults afflicted with long-term type 1 diabetes. In contrast to the last trial, the phase II trial will see an increased rate of dosing conducted over a longer period of time.
As for the goal of the trial, Faustman was quoted in the aforementioned EurekAlert release as having said that the goal of the researchers “in phase II is to create a lasting therapeutic response” through the creation of “a regimen that will treat even advanced disease.”
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 (…) 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.
In other diabetes coverage here at Immortal News, a team of British researchers published an unrelated study which found overweight diabetics to outlive slimmer ones.