The part where people will be recruited and actually start the BCG
part of the human trial will not start for another 18 months,
approximately, according to the timeline laid out on the new Iacocca
Foundation website. There is a lot of things that have to happen
before the actual drug administration can begin.

The part that has already begun is the work on automating the blood
assay. This is technically part of the trial, as I understand it must
be in place before they can proceed to the fullblown trial.

Also, Dr. Faustman just received the first installment from the
Iacocca Foundation of the Join Lee Now funds, so she's now hiring
staffing that will work the trial.

This is real progress. I feel like the actual trial has already begun
because the real ramp up can now begin, and the fact that the assay
has come so far. I'd be willing to bet that the first two projects
will be finished before 18 months, but I'm sure they have to have a
conservative estimate. People hate to hear things will slip, so
everyone will be happy if they start earlier than projected.

She's right on track guys - here's a quote from the new IF website:

Project 1:
The Faustman lab will standardize the manual separation of T cells
from human blood. Results will be validated with 50 consecutive human
blood samples and then translated to a semi-automated system. During
this time the lab will simultaneously work to standardize T cell death
assays to detect autoreactive T cells in individual human blood
samples and then incorporate the assay into the semi automated system
in preparation for the BCG Human Clinical Trial (BCG/HCT). The assay
will be used for patient selection and efficacy assessment suitable
for treatment of Type 1 diabetes using BCG in the BCG/HCT.

Project 2:
The Faustman lab will continue NOD mouse studies using the same
protocols intended to be approved for the BCG Human Clinical Trial and
will analyze the effects of such treatment on autoreactive T cells
from NOD mice.

Timeline: 18 months

Project 3:
In year two and three of this project, patients with type 1 and type 2
diabetes will be recruited along with age matched controls. Patients
will be initially characterized as to levels of autoreactive T cells
using the assay developed in Project 1. Changes in the levels of
autoreactive T cells in volunteers with type 1 diabetes will be
monitored following BCG treatment.


Let's be patient.... We all want it to be yesterday, I of all people
certainly understand those feelings. Just remember, we want the cure
to work, and to be permanent. Let's not get antsy. We want the
team to do all the due diligence up front so they are successful.

Take care,
Stacy Lavery
Team Maryland Captain, JLN Campaign


--- In nathanfaustmantrials@yahoogroups.com, "imcimc1" <imcimc1@...>
wrote:
>
> Why are the trials not starting uuntil 2008? Can someone elaborate
> on this? Thanks
>
>
> --- In nathanfaustmantrials@yahoogroups.com, Gr8discjck
> <gr8discjck@> wrote:
> >
> > http://www.iacoccafoundation.org/grants_diabetes_research.html
> >
> >
> > stacy_lavery <stacy_lavery@> wrote: I received an email
> from Tom Karlya, Executive Producer for the TV
> > show dLife on CNBC (www.dLife.com), along with a picture of Dr.
> > Faustman on the set of dLifeTV. She's going to be on this coming
> > Sunday, August 6, 2006.
> >
> > Spread the word!
> >
> > Here's the caption from under her picture from the email he sent to
> > the State Captains:
> >
> > Dr. Denise Faustman on the set of dLifeTV.
> > The famed researcher joins dLife this week
> > to discuss her work.
> >
> > dLife is on CNBC Sunday at 7:00pm Eastern
> > 4:00pm Central
> > www.dlife.com
> >
> >
> >
> >
> >
> > __________________________________________________
> > Do You Yahoo!?
> > Tired of spam? Yahoo! Mail has the best spam protection around
> > http://mail.yahoo.com
> >
>