Old Vaccine, New Promise. Type 1 Diabetes Treatment Restored Insulin Production in Patients, Now In Pivotal Phase 2 Clinical Trials

Dr. Denise Faustman has been hunting for a Type 1 Diabetes cure for over 20 years and now she has made an advance in her research for a promising vaccine therapy. The goal of Faustman’s therapy is to “reverse advanced diabetes, not just temporarily halt new-onset disease or treat symptoms.” In her Phase 1 trial, the therapy not only demonstrated safety but temporarily restored the ability of the pancreas to produce insulin in patients that had been diagnosed with the disease for an average of 15 years. This therapy was approved by the FDA to initiate a Phase 2 trial. She expects to recruit 150 Type 1 diabetics for a Phase 2 trial lasting 5 years.

Diabetes is an increasing problem in America, with 10% of the population diagnosed. There are two forms of the condition, T1D accounts for 10% of total diabetics. T1D is an autoimmune disease that is caused by immune cells attacking insulin-producing beta cells. Over time a deluge from white blood cells (WBCs) exterminate the beta cells resulting in T1D. There is no cure for diabetes, but recent studies with vaccines show promise.

Dr. Faustman’s team uses a century-old vaccine, bacillus Calmette-Guérin (BCG) to ameliorate diabetes. In the past, BCG has been used to treat tuberculosis and bladder cancer. BCG is a weakened form of the tuberculosis bacterium but strong enough to activate the immune system. During this activation, white blood cells secrete a natural substance, tumor necrosis factor (TNF). In Dr. Faustman’s preclinical and Phase 1 results, a temporary elevation in TNF can eliminate the cells that destroy insulin-producing beta cells.

“The goal of this [Phase 2] randomized, doubleblind, placebo-controlled study is to see if repeat injections of BCG can benefit people with longstanding type 1 diabetes by putting the disease into remission and helping to prevent diabetic complications. Participants will receive 2 injections of either BCG or placebo spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years. Over the course of the study, the investigators will see whether BCG vaccination is associated with improvements in HbA1c and look for beneficial changes in autoimmune status, such as continued elimination of the bad white blood cells that attack the pancreas.”

Dr. Faustman is optimistic about this trial “We’ve worked on this for 20 years.” “We understand the pathway and mechanism of the disease…The tools are in hand. We’ve done the homework.” With passionate and diligent work like Dr. Faustman’s research, a breakthrough in the diabetes field would revolutionize the lives of many Americans and their loved ones.

10 thoughts on “Old Vaccine, New Promise. Type 1 Diabetes Treatment Restored Insulin Production in Patients, Now In Pivotal Phase 2 Clinical Trials

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  1. Your research sounds encouraging!!! My son has had T1D for just 2 years but always has his ears open for hope to not do injections 5 times a day. My son Dylan is 24 yrs old and has only has it for 2+ yrs. If you are ever looking for participants from Canada, he would be very interested!

  2. I’m 50 and have had diabetes Type 1 since I was four. Are you looking for study candidates? My kidney levels are not great but otherwise I’m healthy. I’m very interested in what this study will show.
    Thank you.
    Lydia Peters

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