Navigation Links
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 information about the clinical trials can be found at http://www.faustmanlab.org.

"We are very pleased to see this work come as far as it has," says Lee A. Iacocca, chairman of the Iacocca Foundation. "I made a promise to see a cure for type 1 diabetes in my lifetime, and I intend to keep it. The public support of this trial and a trial for people with this disease is my dream."

The MGH clinical trial was a double-blind, placebo-controlled Phase I human clinical trial to evaluate the safety of BCG vaccination in volunteers with type 1 diabetes. The basis of the trial is preclinical work done in the Faustman Immunobiology Laboratory, as well as other laboratories worldwide, showing that temporarily elevating levels of an immune modulator called tumor necrosis factor (TNF) can eliminate the abnormal white blood cells found in mice and humans with type 1 diabetes. Administration of the BCG vaccine is known to raise TNF levels in humans.


'/>"/>

Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
Source:Eurekalert

Related medicine news :

1. Mass. Eye and Ear receives NEI grant renewal for growing clinical/scientists
2. Mass. General Hospital to create registry for coronary optical coherence tomography
3. Mass. Eye and Ear Infirmary Cataract Surgery Trainer teaches residents cataract surgery
4. Clear rules facilitate continued Web interaction among general practitioners
5. Survey finds general internists leave practice sooner than subspecialists
6. Miles for Hope’s Moving Towards A Cure(SM) Brain Tumor Walk in Boston Raising Funds for Brain Tumor Vaccine and Massachusetts General Hospital
7. Pennsylvania Attorney General Corbett Will File Lawsuit to Block Health Care Reform Legislation
8. Deep brain stimulation reduces epileptic seizures in patients with refractory partial and secondarily generalized seizures
9. AdvancedMD Appoints William Stone Vice President and General Manager of Billing Services Partner Program
10. Delphi Healthcare Parners Announces New General Surgery Hospitalist Program with CarolinaEast Health System in New Bern, North Carolina
11. United Nations Secretary-General Ban Ki-moon, President Bill Clinton, Launch MASSIVEGOOD, a Citizen Solution for Funding Global Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 2016 , ... Stephanie Hebert Insurance Agency, serving families of ... charity campaign. As part of their ongoing community involvement program, funds are now ... children deserve a voice, and in the spirit of neighbors helping neighbors in ...
(Date:2/8/2016)... , ... February 08, 2016 , ... A man who has struggled to quit smoking, ... Laser Therapy , was determined to find solutions to his problems – and he did. ... Digest is ready to introduce his breakthrough inventions to the world and better people's ...
(Date:2/8/2016)... York, NY (PRWEB) , ... February 08, 2016 , ... ... are too much to handle, you are not alone. According to the Center for ... include heart disease, stroke, type 2 diabetes and certain types of cancer, some of ...
(Date:2/8/2016)... Hilton Head Island, SC (PRWEB) , ... February 08, 2016 , ... ... Head and surrounding areas with a vital new community enrichment program, has teamed up ... to local women and children suffering from intimate abuse. To support all those victimized ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local ... the greater Venice, FL area, has initiated a fundraiser for a two year ... just four days after Christmas. To support this beautiful child who is facing ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Cardiovascular Surgery Devices - Medical Devices Pipeline Assessment, ... report, "Cardiovascular Surgery Devices - Medical Devices Pipeline ... Devices currently in pipeline stage. ... comprehensive information on the pipeline products with comparative ... development. The report reviews major players involved in ...
(Date:2/8/2016)... 2016  Labvantage Lx, a newcomer to the ... sexual enhancement product, EnduramenT. Setting a new standard ... a patented biomedical breakthrough molecule that promotes the ... responsible for many biological functions including erectile function. ... Forgoing the use of prescription medications, scientists working ...
(Date:2/8/2016)... TOKYO and FAIRFIELD, N.J. ... (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that ... exclusive development and commercialization rights for OPA-15406 in the ... agreement also provides manufacturing rights.  OPA-15406 is a topical, ... for atopic dermatitis. --> ...
Breaking Medicine Technology: