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From Moorpark, California, USA:

Recently, I saw a report on the news that said human trials have just been approved for INGAP. What is your opinion on how successful this new procedure will be in curing diabetes? What would be a realistic estimate of when we might know if this will or will not be a successful test resulting in a cure?


Recently a Canadian group reported on a greatly improved technique for islet cell transplantation. However, as a cure for diabetes, it still faces two major problems. The first is that donors are scarce and the procedure requires islet cells from two or three for success. The second is the present need for lifetime immunosuppression. To get around the first issue, there has developed a great deal on interest in 'surrogate' cells (i.e. in cells like stem cells or certain genetically engineered cells) that can produce insulin in response to a rise in blood sugar.

INGAP or Islet NeoGenesis Associated Protein is one of a number of substances that can induce new islet cell growth from pancreatal ductal cells in laboratory animals. It is also possible to derive a smaller synthesisable but still biologically active peptide fraction of this protein. This could be of value in type 2 diabetes because there would be no foreign protein rejection, but in type 1A (autoimmune) diabetes, the new cells would still be vulnerable to autoimmune rejection which would require immunosuppressive therapy to conserve the new cells. However, there are new possibilities here as well from techniques that modify this pathology to produce permanent tolerance in short time. Whether INGAP will offer any real advance in management remains to be seen and even if it does it could easily be ten years before such an approach is in the public domain.


Additional comments from David Mendosa, A Writer on the Web:

Phase I and II a trials have begun, according to the Diabetes Institutes Foundation . If those trials are successful, Phase II b and III trials will investigate the peptide 's efficacy in clinical treatment. A very small minority of drugs that enter Phase II trials ever come to market.

The FDA has said that a typical Phase II trial takes two years. Then the Phase III trial typically takes three years and the FDA review takes six months to two and a half years. (See Drug-Development and Drug-Approval Process.) There's no reason I know of that would make the timeline for the INGAP Peptide trials any different.


Original posting 29 Dec 2001
Posted to Research: Cure


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