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:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
Breaking Medicine Technology: