Type-1 Diabetes Vaccine Progressing, Possible Cure On The Horizon?
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A generic drug was recently approved by the U.S. Food and Drug Administration for phase II clinical testing for its ability to treat and possibly cure type-1 diabetes.
According to the Boston Business Journal (BBJ), scientists at the Massachusetts General Hospital (MGH) have been working with a generic vaccine, which usually treats tuberculosis and bladder cancer, as a possible treatment or cure for people living with type-1 diabetes.
The BBJ explains that the generic drug is known to eliminate abnormal white blood cells, also known as T cells, which cause type-1 diabetes.
The drug was first tested on mice and later tested on 103 humans during phase 1, reports Time. During the phase I human trials, participants received two injections, which were administered four weeks apart.
Scientists observed that the two injections during the human trials caused a temporary elimination of T cells. It was also observed that the pancreas of the participants secreted insulin again, albeit moderately.
Medical Express has learned that the generic drug is Bacillus Calmette-Guerin or BCG. The FDA recently approved the study's progress to phase II, which will focus on people with long-term type-1 diabetes.
Dr. Denise Faustman, director of the Immunobiology Laboratory at MGH and principal investigator of the study, announced the progress of the research at the 75th Scientific Sessions of the American Diabetes Associations.
Faustman said: "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."
Referring to the commencement of phase II, Faustman gushed: "...Our goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year."
A total of 150 adults, who have long-term type-1 diabetes, will be needed for phase II, according to Medical Express. Time adds that the participants will range from age 18 to age 60, and they will be observed for a period of 5 years for the research.
Much like the phase 1 human trials, participants of phase II will initially receive two injections, four weeks apart. Then, BCG will be administered annually to the participants for a period of 5 years.
Faustman explained the goal of phase II, saying: "This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease."
As of late, over $19 million out of the $25 million needed to fund phase II of the study has been raised.
