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Mass. General Hospital, Iacocca Foundation announce completion of Phase I diabetes trial
Date:6/28/2010

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

"We are making great progress and are really excited to be able to move this potential treatment to the next stage of clinical testing," says Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at the MGH and an associate professor of Medicine at Harvard Medical School.

The results of the MGH trial showed that low-dose, multi-dosing regimens of BCG vaccination were safe in individuals with type 1 diabetes. There were no severe reactions to the vaccine other than the expected inflammation at the injection sites. BCG is a generic drug that is currently approved in the United States for tuberculosis vaccination and for the treatment of bladder cancer.

"This clinical trial is an important event for both the MGH and the Iacocca Foundation, who have been our partners in this process," says Peter Slavin, MD, president and CEO of Massachusetts General Hospital. "We are putting our energies behind moving the trial into Phase II."

The MGH Immunobiology lab, led by Faustman, will now begin planning for a Phase II clinical trial to continue investigating the safety and efficacy of BCG vaccination as a therapeutic agent for the prevention or reversal of type 1 diabetes. The trial will seek to define the exact dose and timing of administration of BCG vaccination to treat advanced type 1 diabetes. The majority of the funds for Faustman's basic research, on which these human studies are based, have come from the Iacocca Foundation. Additional i
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Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
Source:Eurekalert

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