A Program for the Cure of Type 1 Diabetes Using a Generic Drug: Phase II
Researcher
Denise L. Faustman, MD, PHD. Denise L. Faustman, MD, PhD., Associate Professor Harvard Medical School and Director Immunobiology Laboratory Massachusetts General Hospital Charlestown, MA
Purpose
Dr. Faustman’s lab is currently conducting an FDA-approved Phase I human clinical trial using a generic drug, Bacillus Calmette-Guerin (BCG), in people with longstanding type 1 diabetes. The goal of this trial is to use the drug to kill only the “bad” (autoreactive) T cells so that the human pancreas might spontaneously regenerate. In early 2010, Dr. Faustman expects to complete the Phase I human clinical trial. If no serious side effects from this drug are discovered which is unlikely, since this is a drug that has been used in humans for 80+ years they will then move to Phase II human testing, which will involve more patients and be the next step in seeing if this inexpensive generic is safe and effective in human type 1 diabetes. Based on Dr. Faustman’s lab research, they hope to show that BCG will eliminate a population of disease-causing cells in type I diabetes, without harming healthy cells. In 2001, Dr. Faustman’s laboratory successfully used a similar approach to cure end-stage diabetes in mice. This is the first trial to translate those findings to humans. A project supply grant from Diabetes Action will support the lab in conducting the next phase of necessary human testing.
Source