press release about clinical trial

[Guest guest]

As a follow up, here is the press release from Mass General about the phase 1

clinical trial:

 

 

FOR RELEASE

Thursday, March 13, 2008

 

 

Contact:

Emily Parker, MGH Public Affairs

(617) 724.6425

 

 

MGH Initiates Phase I Diabetes Trial

 

BOSTON, MA – Scientists at the Massachusetts General Hospital (MGH) have

initiated a phase 1 clinical trial to reverse type 1 diabetes. The trial is

exploring whether the promising results from the laboratory of Denise Faustman,

MD, PhD, can be applied in human diabetes. Faustman’s previous studies have

shown that mice with a form of diabetes that closely resembles type 1 diabetes

in humans can be cured. In the animal studies, a commonly used vaccine that

provides protection against tuberculosis, called Bacillus Calmette-Guerin (BCG)

was used effectively to deplete the abnormal immune cells that attack and

destroy the insulin producing cells of the pancreas. The first step in the human

study, which is currently enrolling volunteers, is to determine whether the same

strategy using BCG vaccination can be used to modify the abnormal autoimmune

cells that are present in type 1 diabetes, sometimes called “juvenile-onset”

diabetes.

“We are pleased to be starting human clinical trials,” said Faustman. “Human

trials take time, but we are making the step from curing diabetes in mice to

determining whether it will work in men and women with diabetes.”

Type 1 diabetes usually starts during childhood or adolescence and can cause a

variety of severe complications including kidney failure, loss of vision,

amputations, heart disease, and strokes. It occurs when a person’s immune system

attacks and destroys the insulin-producing cells in the pancreas. In the absence

of insulin, which is necessary for sugar and other nutrients to enter cells,

blood sugar levels rise. The risk for developing complications is closely linked

to the elevated blood sugar levels over time. If blood sugar levels are well

controlled, the long-term complications can largely be avoided. However, the

so-called intensive therapy that is required to maintain near-normal sugar

levels requires life-long demands on the patient, including frequent blood sugar

monitoring and at least 3 daily injections of insulin or use of an insulin pump,

along with restrictive diets. Insulin doses must be adjusted based on blood

sugar levels, dietary

factors, and anticipated exercise. A cure for diabetes has been highly sought

after and has attracted much research interest.

The clinical trial is using the BCG vaccine for several reasons. BCG has been

used safely for nearly 80 years as a tuberculosis vaccine. It is now being used

in the human trial because it causes a low-grade inflammatory reaction, which in

the mouse model of autoimmune diabetes lead to the destruction of the abnormal

autoimmune cells.

David M. Nathan, MD, director of the MGH Diabetes Center, who is leading the

human study at MGH, provides context: “This is the very first step in what is

likely to be a long process in achieving a cure. We first need to determine

whether the abnormal autoimmune cells that underlie type 1 diabetes can be

knocked out with BCG vaccination, as occurred in the mouse studies.”

The Phase I trial is being supported largely through direct and fundraising

support from the Iacocca Foundation, and through support from other donors and

the Massachusetts General Hospital. The Iacocca Foundation was founded by Lee

Iacocca and his family in 1984 to fund innovative approaches to a potential cure

for diabetes. Trial information is available to the public at

www.faustmanlab.org.

 

About the Iacocca Foundation

The Iacocca Foundation has been a leader in the battle against diabetes for over

20 years. The foundation has granted more than $27 million to innovative and

promising research designed to lead to a cure for diabetes and alleviate its

complications. The Foundation was established by Lee Iacocca after his wife,

Mary, died from complications of type 1 diabetes.

 

About the Massachusetts General Hospital

Founded in 1811, the MGH is the third oldest general hospital in the United

States and the oldest and largest in New England. The 900-bed medical center

offers sophisticated diagnostic and therapeutic care in virtually every

specialty and subspecialty of medicine and surgery. Each year the MGH admits

more than 46,000 inpatients and handles nearly 1.5 million outpatient visits at

its main campus and health centers. Its Emergency Department records nearly

80,000 visits annually. The surgical staff performs more than 35,000 operations

and the MGH Vincent Obstetrics Service delivers more than 3,500 babies each

year. The MGH conducts the largest hospital-based research program in the

country, with an annual research budget of approximately $500 million. It is the

oldest and largest teaching hospital of Harvard Medical School, where nearly all

MGH staff physicians serve on the faculty. The MGH is consistently ranked among

the nation’s top hospitals by US

News and World Report.