Sue, that is not a bad thing, right? If there cannot be a cure for
all, a prevention or early intervention would be welcomed for those
who could benefit. After having lived with this monster for almost
17 years, I have doubts of there ever being a cure for those who are
currently afflicted with the disease. But, I would be ecstatic
going to my grave knowing that others would not have to suffer.

--- In nathanfaustmantrials@yahoogroups.com, Sue root
<susan_root@...> wrote:
>
> Don't know the substance but, as with most other studies, it is a
treatment being tested for those early diagnosed.
>
>
> Ellen <ecrain1@...> wrote:
> I pulled the following article from the Children with
Diabetes
> website. I never heard of this study before and was wondering if
> anyone knew what the drug is that they are going to test. It
sounds
> a lot like Dr. Faustman's work in that big pharma is not involved.
I
> thought it was interesting. Any thoughts or information would be
> appreciated.
> Ellen Crain
>
> Brookline diabetes researcher makes FDA history with clinical trial
> By Jessica Scarpati/Staff writer
> Wed Feb 13, 2008, 05:01 PM EST
> Brookline -
> Tools: E-Mail
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>
> Brookline - When that 2-foot-thick stack of paperwork from the FDA
> arrived on Dr. Tihamer Orban's desk, he took one look at it and
made
> his decision about developing a drug on his own and leading the
> clinical trial.
>
> "I said, `There's no way I can do this,'" sighed Orban, an
Aspinwall
> Avenue resident and Hungary native.
>
> Luckily for Type 1 diabetes patients around the world, Orban is
not a
> man of his word — at least in this respect.
>
> The 15-year researcher at Boston's Joslin Diabetes Center has
become
> the second person in the history of the federal Food and Drug
> Administration to get approval to test a drug he developed without
> the help, politics or funding of a big pharmaceutical company.
>
> And if the early successes of his maverick vaccine continue, Orban
> said it could pave the way for finding a cure.
>
> "If this drug will do what I hope it would, then we can make a
major
> impact in Type 1 diabetes," said Orban, a pediatrician by training
> who also is an instructor at Harvard Medical School.
>
> Want to get in on it?
> Take learn more about the B-chain insulin study, go to the Joslin
Web
> site or e-mail Dr. Tihamer Orban.
>
> Representatives from the FDA and the American Diabetes Association
> could not be reached for comment.
>
> Type 1 diabetes is an autoimmune disease — meaning the body
> mistakenly attacks its own mechanisms — that gradually kills off
> insulin-producing beta cells in the pancreas. The body needs
insulin
> to regulate blood sugar to survive.
>
> The disease is also known for having strong genetic ties, though
no
> genetic test has been found yet. It is often found in children,
but
> can present itself later in life as well.
>
> "You have a large prediabetic time," Orban said, explaining that
> patients can still have 30 to 40 percent of their insulin-
producing
> cells intact at this time. "You have the disease process, but you
> don't have the clinical disease."
>
> As a result, Orban's work focuses as much on prevention as it does
> intervention.
>
> "The only thing is to do is to stop the auto-aggressive process,"
he
> said. "This sounds very simple, but is very difficult to do."
>
> Often putting in 10- to 12-hour days, Orban said he still finds
the
> work rewarding, even though a cure has eluded him and thousands of
> others before him.
>
> "I'd rather fail 10 times than not try," he said. "If you think
it's
> meaningful, then the time passes by, and you go home and
> think, `Bloody hell, I haven't done half.'"
>
> Trial of few errors, so far
> In his "investigator initiated" drug trial, Orban said he bucked
the
> usual trends of focusing on immunosuppressive drugs that try to
stop
> Type 1 patients' bodies from destroying insulin.
>
> "This is actually conceptually different," Orban said. "This is
> actually a stimulatory agent."
>
> Here's how it works.
> "I came up with the concept that autoimmune Type 1 diabetes is the
> loss of self-tolerance," Orban said. "So, what I thought would be
> most adequate was to remind the immune system of the antigen — of
> what it forgot about."
>
> Orban said the immune system learns to tolerate "self material"
early
> in life, through T cells in the thymus, a lymphatic organ in the
> chest. He called it "thymic education."
>
> "You go to school, you have to learn, `This is mine — don't
bother,
> don't kill,'" he said. "In autoimmunity, this memory is not lost
> completely, but it is mostly forgotten."
>
> How could he remind the immune system to recognize
> insulin? "Vigorous" doses of insulin might work, except that a
> patient would become hypoglycemic and die.
>
> That is, until Orban started to break up insulin's structure —
which
> appears as a ladder, an "A chain" and a "B chain," glued together
by
> chemical bonds.
>
> Orban said he isolated the B chain, which is not metabolized the
same
> way as the whole insulin structure.
>
> "I can give an unlimited amount," he said, which for his trial,
> translated into a one-time shot of 2 milligrams of B-insulin — an
> amount the average adult produces over two years.
>
> Orban said he alone did most of the toxicology studies for his
> nameless injection before presenting it to the FDA. He hired an
> independent toxicology lab to verify the results.
>
> The FDA signed on, and Orban got funding for the human trial from
the
> National Institutes of Health, the federal government's research
> agency.
>
> Having just completed the first phase of a two-year clinical trial
> for the new drug on 12 patients — half of whom received a placebo —

> Orban is beginning to gather 100 to 120 people for the second
phase
> of trials to support his results.
>
> "We looked for … whether we can wake up the immune system," he
> said. "I can tell you we did."
>
> That first group showed no side effects, which was another big
win —
> especially for a drug that could be used among infants and
children.
>
> Though in addition to securing patients, Orban must also find
public
> and private funding. A trial such as this, he said, costs "several
> millions" of dollars.
>
> "We got a clear immune response that I don't think anybody has
really
> achieved," Orban said. "But these are very early, so I wouldn't
> overstate that. We need to study this more."
>
> What do you think? Add your comments at
www.wickedlocal.com/brookline.
>
> Jessica Scarpati can be reached at jscarpat@...
>
>
inthehttp://www.wickedlocal.com/brookline/news/lifestyle/health/x2303
8
> 0968
>