Sunday, July 29, 2018

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A PROGRAM FOR THE CURE OF TYPE 1 DIABETES USING A GENERIC DRUG: PHASE II

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Researcher:
Denise L. Faustman, MD, PhD., Associate Professor
Harvard Medical School and Director Immunobiology Laboratory
Massachusetts General Hospital
Charlestown, MA
Purpose:
In August 2012, publication of the Phase I trial showed that the pancreas of long-term diabetics was able to transiently make insulin after two doses of the Bacillus Camlette-Guerin (BCG) vaccine. All Phase I clinical trial subjects who received the BCG vaccine were followed for 8 years. In 2018 a follow-up report of the 282 participants, published in the journal Vaccines, showed positive results in normalizing blood sugars after 8 years from the initial treatment with the BCG vaccine. In order to meet the goal of reversing advanced type 1 diabetes, the Phase II clinical trial was approved by the FDA in June, 2015 and that trial is now fully enrolled with 150 participants who have received at least 2 doses of the BCG vaccine or placebo. In order to meet the ultimate goal of bringing BCG to market with an approved indication for treating type 1 diabetes, it is necessary to obtain funding to

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