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Re: [IP] new islets from duct cells

This comes from the Strelitz (sp?) Institute and the protein is called
INGAP.  Lily has let the rights to it lapse and another company has taken
it up. GMP Companies" (http://www.gmpcompanies.com/) has licenced it.   Dr,
Vinik was the PI and he has had several chats on the subject.  Here are
some excerpts: lots of snips....Mid Nov. 2000

> Aaron I. Vinik, M.D., Ph.D. - Yes we have gotten along way since our last
>chat. We do not have to insert the Ilotropin into the pancreas. Ilotropin
>was the original crude extract of regenerating pancrease that we gave to
>animals and showed that it could reverse diabetes. Since then we have
>cloned and sequenced the gene for INGAP which we now know is the major
>constituent of Ilotropin and is capable of doing the same thing. We give it
>by injection, very much the sma way we give insulin and it hones in on the
>pancreas where it does its thing.
>. - When we started this work back in 83 nobody believed that it was
>possible to cause a stem cell to grow into a new islet. In fact it was
>heretical to believe that there were stem cells in the pancreas that
>retained the capacity to regrow. This certaily did not appear in the
>textbooks let alone some of the journals. With years of painstaking work
>and confirmation of our studies by other laboratories it is now the
>accepted norm.We have a team working on the problem and are making very
>good progress
>We are starting large animal work within the next few weeks. AIV
>We are working closely with two people who are former members of the FDA to
>be sure that we do the right things en route to develloping this as a
>treatment for humans. We are planning a set of experiments in preparation
>for an FDA meeting to be sure we are on the right wavelength with the FDA.
> In the hamster studies we have done we have given several injections over
>a short period and then had complete recovery without the need for further
>treatments We have just completed a study in mice and done exactly the same
>thing.After a course of treatments all the mice recoverd and we did not
>have to go back to retreat. We do not know now that this will be the case
>in all instances. But what would be so bad if every now and then one needed
>a shot to fill up the tank again? AIV
>The fortunate thing about INGAP is that we can produce gallons if we have
>to. Our most recent discovery is that one does not need the whole molecule
>to stimulate islet growth. We now know that a small peptide, just 15
>amonioacids, part of the INGAP protein sequence from amonoacids 104-118 is
>all that is required for this action. We have just had 100's of grams
>synthesized in the test tube and can make lots by recombinant technology
>using bacteria. This is a while lot better than the acutre limitations of
>islet transplant methods. AIV
>when the islets regenerate they produce insulin in a normal manner and the
>precursor proinsulin and its derivative C-peptide are part of the process.
>What is more exciting to us now is that the reconstituted islet develops
>all the other hormones produced by the islet including glucagon. What
>happens to people with intensive glycemic control or organ transplantation
>is that they lose the ability to counter-regulate their blood glucoses and
>are prone to hypoglycemia. With the abilty to make glucagon, one of the
>bodie's primary defenase mechanisms this abiltity to combat hypoglycemia is
>restored. AIV
>How much is too much is part of the reason for the need for safety studies.
>We have given gross overdoses to animals and not observed any toxicity at
>all. We are now giving humungus doses to be sure that we are operating in
>the safety zone. This will allow us to choose the best doses and schedules
>to use later. AIV
>The large animals planned for the next phase are dogs. We will also be
>doing mice. We are abiding by the FDA requirements for toxicity studies. We
>are also in the planning phase of efficacy studies in dogs. AIV
>we plan to meet with the FDA early in the New Year to be sure that we do
>everything by the book so to speak so that there is no obstruction to
>pursuing a rapid course to the human studies. We also have an advisory
>board selected from the most prominent diabetes experts and researchers
>from all over the world to fine tune our progress in this direction.
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