A Phase II clinical trial exploring the vaccine bacillus Calmette-Guérin (BCG) as a treatment for type 1 diabetes has been approved by the U.S. Food and Drug Administration (FDA). The approval was announced at the 75th Scientific Sessions of the American Diabetes Association.

Set to last for five years, the clinical trial will be investigating whether repeatedly vaccinating with BCG can improve the conditions of adults 18 to 60 years old with type 1 diabetes but still have small but detectable traces of insulin secreted from their pancreas. Led by Denise Faustman, M.D., Ph.D., the researchers were the first to document advanced cases of type 1 diabetes being reversed in mice. They also successfully completed a Phase I clinical trial of the BCG vaccine.

"This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease," said Faustman of the Phase II clinical trial.

BCG is backed by more than 90 years of safety data and clinical use. It currently has the FDA's approval for use in treating bladder cancer and tuberculosis. BCG works by raising immune modulator tumor necrosis factor (TNF) levels, which has been previously shown to temporarily eradicate abnormal-behaving white blood cells that cause the autoimmune-type of type 1 diabetes in mice and humans. When TNF levels increased, levels of protective T cells were also boosted.

The Phase II clinical trial will use more frequent dosages over the course of a longer period of time compared to what was utilized in the first clinical trial. To be conducted at the Massachusetts General Hospital, it will involve 150 adult subjects who have been living with type 1 diabetes for a long-term period.

The participants will be randomly chosen to receive two shots of either a placebo or BCG every four weeks, followed by an injection every year for the next four years. They will then be monitored closely for the duration of the trial period. Primary outcomes will be measured based on improvements on HbA1c blood tests.

The Phase II trial, as well as its Phase 1 counterpart, received significant support from the Iacocca Foundation. Lee Iacocca, the founder, said he promised his late wife that he would find a means of curing type 1 diabetes and he is very excited now to be working on curing people and not just mice.

The Phase II clinical trial will need $25 million to conduct its study over the course of five years. So far, over $19 million has already been raised. The clinical trial will be done in MGH, the largest and oldest teaching hospital of the Harvard Medical School.

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