A Bioassay for Diabetes

In 2001, researchers led by Denise Faustman, MD, PhD, at MassachusettsGeneral Hospital (MGH) reversed and cured type 1 diabetes in mice.The development and refinement of a bioassay is part of their ongoingresearch to bring these findings to human trials. Their first human trial,an FDA-approved trial using a bacillus Calmette-Guerin (BCG) vaccine, isexpected to start later this year once sufficient funding has been raised.

What Is a Bioassay?

A bioassay is a blood-based test. The bioassay being developed bythe Faustman lab will, hopefully, allow the researchers to measure theconcentration of diseased cells in blood samples from type 1 diabetics;measure T cell levels to evaluate how well any tested therapies work;and determine the most optimal times and doses to administer thetested therapies.

Not only will the bioassay provide the researchers with usefulinformation, it will also automate a process of blood testing that hasbeen done by hand (taking up to one and a half days to complete eachindividual blood sample), thus speeding up the process significantly.

The Importance of This Blood Test

Developing a human cell-based assay for autoimmunity has never beendone before. This technology will be extremely important for the humantrials. For example, if someone discovered insulin but did not have away of checking blood glucose levels, what would be the chance a trialtesting insulin could uncover the correct, beneficial dosing of insulin?This is the concept of the human cell-based assay for autoimmunity—the researchers need to know how much of a drug to use to produce aresponse.

In the first human trial, they will need to measure the pathogenic(disease-causing) T cells to see if BCG is eliminating them. If they arebeing eliminated, they need to know what the best dosing of the drug is.If they cannot measure these T cells, there is a reduced chance they canachieve correct BCG dosing. The successful development of a bioassaywill allow researchers to conduct the first phase 1 trial and then move tolater-stage clinical testing as quickly and cost-effectively as possible.

How Can I help?

The first three years of this program—includingrefinement of the experimental therapy,technology development and the first phase 1clinical trial—will cost an estimated $11 million.Contribute to Join Lee Now and support theseefforts to cure type 1 diabetes in humans.

Donations may be made over the Internet or bymail.

To make a donation over the Internet, please visitwww.JoinLeeNow.org and click on “Donate Now.”

U.S. mail:
To mail your donation, please make checkspayable to “Iacocca Foundation.” Please write“Join Lee Now” in the subject line. All donationscan be sent to the following address:

The Iacocca Foundation
17 Arlington Street
Boston, MA 02116

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