Hi all -

I just received this update regarding Dr. Faustman's research, about
which I know everyone is eager to hear:

*It is estimated that the phase I human clinical trial will begin in
January 2008.

*The Faustman/Nathan human clinical project will be the first to
attempt a treatment to hault the underlying autoimmune disease in
humans who have been living with diabetes beyond early diagnosis.

*At the 2007 ADA conference, presented studies support Dr. Faustman's
research in mice.

*One year ago, the Faustman lab received the first $1.3 million from
The Iacocca Foundation¢s Join Lee Now campaign. Six months later, in
January, the lab received an additional $1.3 million. The Iacocca
Foundation gave $1.8 million to the Faustman/Nathan project this month.

*After 1 year, the research is ahead of schedule in its translation
through a phase I human clinical trial with the estimated $11.5
million cost over a 3 year period.

*The lab continues to be very busy collecting blood samples from
people of all ages living with diabetes for a few weeks to over 40
years. The blood samples are being put through the designed automation
process. This has been essential in developing the human blood assay
for autoimmunity.

*The automation of the blood assay is going very well. The basic
process has been developed now. The lab is concentrating on performing
different assay techniques in order to determine the best test(s) that
will be used for the human clinical trial (i.e. size of blood samples
for best reliability needed).

*The lab plans to measure TNF alpha levels, auto-antibodies, and
C-peptide levels during the trials.

*The lab has begun the process of searching for generic substances
that can be used for part 2 of the treatment.


Important notes about Dr. Faustman's research:
1. The development and automation of the human blood assay for
autoimmunity is innovative and unique from any other human clinical
trial for type I diabetes as it will enable the scientists to
accurately measure the depletion of the targeted T-cells. This is
essential in order to determine drug dosing to be successful. Giving
one big blast of BCG blindly would ultimately result in failure. An
analogy would be doing a trial with a new insulin by giving one huge
dose and at the same time the scientists could not measure the change
in blood glucose levels.

2. The Nathan/Faustman project has chosen to use generic, readily
available substances as opposed to testing a newly manufactured drug.
The chosen drug of choice, BCG, is known to be an immune stimulant
that stimulates TNF alpha in the body. Multiple independent labs have
confirmed that TNF alpha kills off the targeted T cells in NOD mice.
The Faustman lab's preclinical work demonstrates the depletion of the
targeted T cells with TNF alpha in blood samples from humans. The use
of generic drugs will ultimately cut cost and time substantially in
order to bring the treatment to the public and most importantly, the
long-term safety is already known. Pharmaceutical companies are not
interested in financially supporting pre-clinical and phase I trial
work with cheap, generic drugs.

3. The only treatment in NOD mice (the animal model for type I
diabetes) that reverses and cures diabetes beyond pre-diabetic/early
onset stages and that could potentially be used as a readily available
treatment for humans.

4. The treatment is based on two defects found in the immune system of
NOD mice. The same defects are found in humans with type I diabetes
and other autoimmune diseases such as multiple sclerosis, lupus,
Chron's disease, and scleraderma.

Lastly, it is a miracle the research has gotten this far with private
philanthropy. It is imperative that the fundraising continue in order
to progress the research through phase II without delay.

Thanks!
Stacy Lavery
Team MD Captain, JLN Campaign
Nathan/Faustman Trials Yahoo Group Moderator