The FDA gives the green light on phase II trials of the Bacillus Calmette-Guerin (BCG) vaccine to treat type 1 diabetes patients.
The US Food and Drug Administration (FDA) has approved a new promising vaccine that eliminates type 1 diabetes in humans for phase II clinical trial. The vaccine called Bacillus Calmette-Guerin (BCG) was effective in permanently reversing long term type 1 diabetes in mice by eliminating the bad T cells that kill the insulin producing cells of the pancreas. Humans with type 1 diabetes have similar bad cells that also hinder insulin producing capabilities. The BCG Human Clinical Trial Program began in 2008 with 103 adults and the results of the program show that BCG is a promising treatment for advanced type 1 diabetes.
The first phase of the trials essentially looked into the effects of the BCG vaccine in advanced type 1 diabetes patients who had the condition for an average of 15 years. The trial was successful in concluding that the vaccine was absolutely safe for humans to take and recorded no severe reactions apart from mild inflammation at the place where the drug was injected, which was expected. The US Food and Drug Administration (FDA) and the MGH data safety monitoring board reviewed all the safety data submitted to them. Phase I focused on the effects of the BCG vaccine to treat type 1 diabetes patients without cell transplants or lifelong immunosuppressive drugs being administered during the study. The vaccine was designed to destroy only bad cells and spare the healthy ones.
The second phase of trials on humans is to take place over the next five years and will be used to experiment the results on adults between 18 and 60 years of age who have suffered from type 1 diabetes for many years. The BCG vaccines will be studied to analyze its effects to further improve the vaccine before making it available as a successful cure for type 1 diabetes patients. The primary investigator of the study, Denise Faustman, said the phase I clinical trial was successful in implementing a statistically significant response to BCG. Faustman, who is director of the Massachusetts General Hospital (MGH) immunobiology laboratory confirmed that they’re expectation of the phase II study is to analyze and develop a lasting therapeutic response to the vaccine.
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