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MGH study finds generic drug can reverse type 1 diabetes long-term
by Jessica Bartlett – Reporter, Boston Business Journal – Jun 21, 2018, 6:25 AM
Research at Massachusetts General Hospital looks increasingly like a long-term cure for type 1 diabetes, with a newly released study on Thursday showing patients have normal blood sugar levels eight years after a clinical trial.
In research published Thursday in journal npj Vaccines, patients who had been treated with the bacillus Calmette-Guerin (BCG) vaccine — an inexpensive, generic vaccine used around the world to prevent tuberculosis — had normal blood sugar levels eight years after the trial ended.
While it took three years for patients to see results from the vaccine, two doses of the drug spaced four weeks apart were still having a lasting impact eight years later.
“It’s kind of big news,” said Dr. Denise Faustman, director of the Massachusetts General Hospital immunobiology laboratory and principal investigator of the trial. “It’s the first trial showing (long-term reversal of diabetes), and more trials are on the way. But scientifically it’s pretty cool.”
The recently published study also details how the vaccine genetically alters the body’s white blood cells so they process glucose, making up for the pancreas’ inability to produce insulin to do the same. In type 1 diabetes — referred to in the past as juvenile diabetes — the immune system damages the pancreas and blocks the cells from producing insulin.
“It’s not only the discovery that something cheap in new cohorts brings down blood sugar, but why. We’ve discovered new pathways for lowering blood sugar,” Faustman said. “It’s an important discovery for the basic science of diabetes care. And by the way, we have a cheap BCG vaccine that seems to be doing it.”
Faustman has been working for over a decade on trials of the treatment, first in mice and then in humans. In addition to follow-ups with patients from the phase 1 clinical trial, a phase 2 clinical trial, which has been funded largely by support from the Iacocca Family Foundation, is ongoing. Faustman’s lab is still seeking the final $2 million of the $25 million cost.
The goal of the latest clinical trial is to replicate results from the first phase, as well as to analyze the dosing necessary to make the vaccine work quickly. The study isn’t accepting more patients, but Faustman encouraged patients to sign up when the trial is hopefully expanded.
News of the dramatic results has been trickling out as Faustman progresses work with the vaccine. Last year, Faustman discussed the research on the mechanism of the drug at the Scientific Sessions of the American Diabetes Association and in an interview with the Boston Business Journal. She said she waited until the eight-year clinical results were ready to publish the findings on how the drug works, in order to give more credence to the vaccine’s success.
Used in China, Africa and South America to vaccinate against TB, the BCG vaccine has been used 4 billion times over the last 100 years. Last year alone, 100 million doses of the vaccine were given to newborns. Because TB isn’t common in the U.S., children here do not receive the vaccine.
Faustman’s trial is one of several happening nationally on BCG. There is ongoing research into the drug’s effect on multiple sclerosis in Italy, and on food allergies in Australia.
The microorganism originates from the dirt. Faustman said the rise of autoimmune disorders, and the increase of food allergies and gluten intolerance, is tied to the fact that humans no longer interact with dirt in the way they once did.
Faustman has her sights set on more than just completing the phase 2 clinical trial. She hopes to also conduct a trial on the vaccine in children with type 1 diabetes, and to possibly make the drug available for right-to-try trials. There could also be future studies on whether the drug can work in type 2 diabetes.
“It’s a significant advance since the discovery of insulin, and it needs to be duplicated and replicated and expanded,” Faustman said.
A phase II clinical trial testing the ability of the generic vaccine bacillus Calmette-Guérin (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 has already begun enrolling qualified patients, was announced 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. Faustman’s 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 made this trial possible – especially the Iacocca Foundation, which has believed in us and has been a supporter since our early days.”
A generic drug with over 90 years of clinical use and safety data, BCG is currently approved by the FDA for vaccination against tuberculosis and for the treatment of bladder cancer. The vaccine is known to elevate levels of the immune modulator tumor necrosis factor (TNF), which Faustman’s team previously showed can temporarily eliminate in both humans and mice the abnormal white blood cells responsible for autoimmune type 1 diabetes. Increased TNF levels also stimulated production of protective regulatory T cells.
In the phase I clinical trial, which was published in the August 8, 2012, issue of PLOS Medicine, two injections of BCG spaced four weeks apart led to temporary elimination of diabetes-causing T cells and provided evidence of a small, transient return of insulin secretion. The phase II clinical study will include more frequent dosing over a longer time period to determine the potential of repeat BCG vaccination to ameliorate the autoimmune state and improve clinical parameters such as HbA1c, a marker of average blood sugar control.
In the new trial, which will be double blinded and conducted at MGH, 150 adults with long-term type 1 diabetes will be randomized to receive two injections four weeks apart of either BCG or placebo and then a single injection annually for the next four years. Patients will be closely monitored over the five-year trial period. The primary outcome measure will be improved results on the HbA1c blood test, which have been shown to prevent complications.
“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,” says Faustman, an associate professor of Medicine at Harvard Medical School. “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.”
Lee Iacocca, founder of the Iacocca Foundation, says, “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. 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.” The Iacocca Foundation provided major funding for the phase I trial and has taken a leadership role in funding the phase II trial.
Visit the Faustman Lab’s Facebook Page and stay up to date on their progress.
For more information on the clinical trials and the research study please click on faustmanlab.org
On behalf of the 3 million people with type 1 diabetes, their family and friends we thank you for your commitment to our cause and our promise to find a cure!