MGH Researcher’s Diabetes Quest Takes Big Step
The FDA approves the second phase of Dr. Denise Faustman’s clinical testing of a type 1 diabetes vaccine, an exciting next step in her pursuit of a therapy to reverse the disease.
After nearly 20 years of research, Massachusetts General Hospital researcher Denise Faustman, MD, PhD, has made a promising advance in her quest to cure type 1 diabetes.
Her team recently passed a major threshold by receiving FDA clearance to test a large group of long-term diabetics with an old tuberculosis vaccine that could also combat type 1 diabetes. The phase 2 trial of the bacillus Calmette-Guérin (BCG) vaccine was announced last month at an American Diabetes Association conference in Boston, an exciting next step in Dr. Faustman’s pursuit of a therapy to reverse the disease.
“We’re in full action mode. The phones are ringing off the hook.”
While thrilled about receiving the FDA’s blessing, Dr. Faustman and her staff didn’t celebrate for long. They’re already accepting applications for patients who want to participate in the five-year trial that starts this summer.
We’re in full action mode. The phones are ringing off the hook,” Dr. Faustman says. As many as 100,000 diabetics are expected to volunteer for the clinical trial, but the MGH Immunobiology Laboratory will winnow the number of participants to 150 adults, with some receiving BCG and others taking a placebo.
Old Vaccine, New Promise
The FDA approved the phase 2 trial essentially by certifying MGH’s use of BCG that will be produced by the Japanese government. Academics usually don’t have to look around the wo Continue reading