TB vaccine can help reverse diabetes – tech2.org

TB vaccine can help reverse diabetes

A vaccine that prevents tuberculosis and is used to treat bladder cancer has been approved for clinical trials in the United States. UU To test your ability to reverse advanced type 1 diabetes.

The US Food and Drug Administration. UU He pbaded a phase II clinical trial that tests the ability of the bacillus of the generic Calmette-Guerin vaccine (BCG) to reverse advanced type 1 diabetes.

In a five-year course, the trial will investigate whether repeated BCG vaccination can clinically improve type 1 diabetes in adults between 18 and 60 years old who have small but still detectable levels of insulin secretion from the pancreas.

Denise Faustman, director of Mbadachusetts General Hospital (MGH) and her research team, was the first group to document the reversal of advanced type 1 diabetes in mice and subsequently completed a successful phase I clinical trial of BCG vaccination .

"We have learned a lot from early studies in mice, not only about how BCG works but also about its potential therapeutic benefits, similar to those seen in trials against other autoimmune diseases," said Faustman.

"Our goal is to complete the registration and also to raise the remaining funds needed for the trial before the end of the year," he said.

A generic drug with more than 90 years of clinical use and safety data, BCG is currently an application. The vaccine is known to elevate the levels of modulating tumor necrosis factor (TNF), which Faustman's team previously showed that It can temporarily eliminate both humans and mice. the abnormal white blood cells responsible for type 1 autoimmune diabetes.

The increase in TNF levels also stimulated the production of protective regulatory T cells.

In phase I of the clinical trial, two injections of BCG spaced four weeks resulted in temporary elimination of T cells causing diabetes and provided evidence of a small and transient return of insulin secretion.

Phase II clinical study will include a more frequent dosing over a longer period of time to determine the potential for repeated BCG vaccination to improve autoimmune status and improve clinical parameters such as HbA1c, a marker of average sugar control in the blood.

About 150 adults with long-term type 1 diabetes w It will be randomized to receive two injections with four weeks of BCG or placebo and then a single injection annually for the next four years.

Patients will be monitored closely during the five-year trial period. The primary outcome measure will be the best results in the HbA1c blood test, which has 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," said Faustman, an badociate professor at Harvard Medical School in the United States. .

"We will be working with people who have had type 1 diabetes for many years now, it is not a prevention trial, we are trying to create a regimen that treats even advanced disease," he said.

(This story has not been edited by the Business Standard staff and is automatically generated from a syndicated feed)


Source link