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LWM HEALTH UPDATES & ALERTS Diabetes Research: A promising Clinical Trial


After their early findings in studies with mice, she said they tried to interest every major drugmaker in developing the vaccine as a possible cure for diabetes. All told her there wasn’t enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said.


A tuberculosis vaccine in use for 90 years may help reverse Type 1 diabetes and eliminate the lifelong need for insulin injections, says Denise Faustman, MD, PhD, director of the MGH (Massachusets General Hospital) Immunology Lab, and David Nathan, MD, director of the MGH Diabetes Center Te vaccine, a weakened form of the tuberculosis bacteria, stimulates production of TNF, a cell-signaling protein that plays a role in cell death. With more TNF, the body can atack those harmful immune cells while leaving the rest of the body’s defenses intact. Te vaccine is approved by the U.S. Food and Drug Administration for tuberculosis though it isn’t generally recommended for use in the U.S. Te vaccine also is approved to fight bladder cancer.


Patients with Type 1 diabetes must inject insulin daily to control their blood sugar because their bodies don’t produce the hormone, the result of an errant immune system that destroys insulin-producing cells in the pancreas. insulin injections help control Type 1


diabetes for the 3 million Americans with the disease, though there is no cure for the condition usually diagnosed in childhood. Te vaccine, called bacillus Calmete-Guérin, or BCG, stimulated production of a protein that killed the insulin-atacking cells, according to the findings of an early-stage study.


Under the direction of Denise Faustman, MD, PhD, director of the MGH Immunology Lab, and David Nathan, MD, director of the MGH Diabetes Center, a Phase I human clinical trial was conducted and demonstrated that vaccination with BCG is safe in individuals with type 1 diabetes, can eliminate the pancreas-destroying T cells, and can temporarily restore the ability of the pancreas to produce insulin. Results of the trial showed that two of the three patients given BCG had signs of renewed insulin production. Te next step, a Phase II study, is currently being planned to identify the “best” dose of BCG and the best schedule for giving this potential new therapy to achieve the desired effects. “We think this can be taken all the way to the market and that


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is what we are trying to do.” said Denise Faustman, director of Harvard-affiliated Massachusets General Hospital’s immunobiology laboratory, who led the study.


Faustman and her colleagues at Massachusets General in Boston are working to get the vaccine to market. Aſter their early findings in studies with mice, she said they tried to interest every major drugmaker in developing the vaccine as a possible cure for diabetes. All told her there wasn’t enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said.


Currently the researchers are trying to raise money to pay for the expensive larger human trials. Her lab so far has received $11 million of the $25 million needed to pay for the next stage of testing. All of the money is coming from private donors, the largest of which is the Iacocca Family Foundation.


For more information www.faustmanlab.org.


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October 2012


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