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Massachusetts General Hospital, Iacocca Foundation announce promising results of Phase I diabetes trial
Date:6/25/2011

Promising results of the Phase I clinical trial of the generic drug BCG (bacillus Calmette-Guerin) to treat advanced type I diabetes were announced today at the American Diabetes Association scientific sessions in San Diego. A research team led by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory is presenting two abstracts (No. 2240-PO and No. 0057-LB) the first which describes the apparent reproduction in human patients of the mechanism that reversed type 1 diabetes in a mouse model and the second proposing that lack of a key part of that mechanism may explain why recent trials of an antibody-based diabetes therapy were not successful. The Iacocca Foundation has been the primary supporter of this work.

"We found that even low doses of BCG could transiently reverse type 1 diabetes in human patients," Faustman says. "One of the key components of this study was our development of a way to measure the death of the autoreactive T cells that destroy the ability of the pancreas to produce insulin. Not only did we observe and measure the death of these self-targeting immune cells, but we also saw evidence of restoration of insulin production even in patients who've had type 1 diabetes for more than a decade."

A generic drug with 90 years of safety data, BCG is currently approved by the U.S. FDA for vaccination against tuberculosis and for the treatment of bladder cancer. BCG is known to elevate levels of the immune modulator tumor necrosis factor (TNF), which previous work in Faustman's lab showed can temporarily eliminate the abnormal white blood cells responsible for type 1 diabetes in both humans and mice. The Phase I double-blinded clinical trial enrolled six long-term type 1 diabetes patients, diagnosed for an average of 15 years. The participants were randomly assigned to receive two injections of either BCG or a placebo spaced four weeks apart.

Blood samples from the parti
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Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
Source:Eurekalert

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