Featured Research

from universities, journals, and other organizations

Promising results of Phase I diabetes trial

Date:
June 27, 2011
Source:
Massachusetts General Hospital
Summary:
Medical researchers report promising results of the Phase I clinical trial of the generic drug BCG (bacillus Calmette-Guerin) to treat advanced type I diabetes.

Promising results of the Phase I clinical trial of the generic drug BCG (bacillus Calmette-Guerin) to treat advanced type I diabetes were announced June 26 at the American Diabetes Association scientific sessions in San Diego. A research team led by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory is presenting two abstracts (No. 2240-PO and No. 0057-LB) -- the first which describes the apparent reproduction in human patients of the mechanism that reversed type 1 diabetes in a mouse model and the second proposing that lack of a key part of that mechanism may explain why recent trials of an antibody-based diabetes therapy were not successful. The Iacocca Foundation has been the primary supporter of this work.

Related Articles


"We found that even low doses of BCG could transiently reverse type 1 diabetes in human patients," Faustman says. "One of the key components of this study was our development of a way to measure the death of the autoreactive T cells that destroy the ability of the pancreas to produce insulin. Not only did we observe and measure the death of these self-targeting immune cells, but we also saw evidence of restoration of insulin production even in patients who've had type 1 diabetes for more than a decade."

A generic drug with 90 years of safety data, BCG is currently approved by the U.S. FDA for vaccination against tuberculosis and for the treatment of bladder cancer. BCG is known to elevate levels of the immune modulator tumor necrosis factor (TNF), which previous work in Faustman's lab showed can temporarily eliminate the abnormal white blood cells responsible for type 1 diabetes in both humans and mice. The Phase I double-blinded clinical trial enrolled six long-term type 1 diabetes patients, diagnosed for an average of 15 years. The participants were randomly assigned to receive two injections of either BCG or a placebo spaced four weeks apart.

Blood samples from the participants with diabetes were also compared with samples from six nondiabetic participants and with reference samples from 75 additional individuals with diabetes and 15 without. Four measurements were analyzed for each sample -- levels of autoreactive T cells; levels of the regulatory T cells that help control the immune response; levels of GAD autoantibodies, which are a marker of pancreas activity; and levels of C-peptide, a marker of insulin secretion.

Most participants treated with BCG showed increases in both the death of autoreactive T cells and in levels of the protective regulatory T cells. A temporary but statistically significant elevation in C-peptide levels, suggesting a restoration of insulin production, was also observed in the BCG-treated patients. Unexpectedly, the same responses were seen in one of the placebo-treated patients who, after enrolling in the study, coincidently developed infection with the Epstein-Barr virus, which is known to induce expression of TNF.

"These data support our hypothesis that BCG may benefit human type 1 diabetes by boosting TNF levels," says Faustman. "The data from the EBV-infected patient show that induction of TNF expression from diverse sources may have been a missing component in two recent, unsuccessful Phase III trials that tested antibodies against the immune molecule CD3 in type 1 diabetes patients. Those trials were specifically designed to avoid reactivating any latent EBV infection, but blocking EBV activation could also block TNF expression."

In addition to providing major funding for the now-completed Phase I trial, the Iacocca Foundation has committed to a leadership role in the Phase II clinical trial that was initiated at MGH earlier this month. Currently $8.5 million has been raised out of a total of $25 million needed to conduct the Phase II study over the next three years.


Story Source:

The above story is based on materials provided by Massachusetts General Hospital. Note: Materials may be edited for content and length.


Cite This Page:

Massachusetts General Hospital. "Promising results of Phase I diabetes trial." ScienceDaily. ScienceDaily, 27 June 2011. <www.sciencedaily.com/releases/2011/06/110626145244.htm>.
Massachusetts General Hospital. (2011, June 27). Promising results of Phase I diabetes trial. ScienceDaily. Retrieved November 25, 2014 from www.sciencedaily.com/releases/2011/06/110626145244.htm
Massachusetts General Hospital. "Promising results of Phase I diabetes trial." ScienceDaily. www.sciencedaily.com/releases/2011/06/110626145244.htm (accessed November 25, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Tuesday, November 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

Newsy (Nov. 25, 2014) The US FDA is announcing new calorie rules on Tuesday that will require everywhere from theaters to vending machines to include calorie counts. Video provided by Newsy
Powered by NewsLook.com
Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Newsy (Nov. 25, 2014) Need another reason to eat yogurt every day? Researchers now say it could reduce a person's risk of developing type 2 diabetes. Video provided by Newsy
Powered by NewsLook.com
Madagascar Working to Contain Plague Outbreak

Madagascar Working to Contain Plague Outbreak

AFP (Nov. 24, 2014) Madagascar said Monday it is trying to contain an outbreak of plague -- similar to the Black Death that swept Medieval Europe -- that has killed 40 people and is spreading to the capital Antananarivo. Duration: 00:42 Video provided by AFP
Powered by NewsLook.com
Are Female Bosses More Likely To Be Depressed?

Are Female Bosses More Likely To Be Depressed?

Newsy (Nov. 24, 2014) A new study links greater authority with increased depressive symptoms among women in the workplace. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins