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March 2007 Update on Research to Cure Type-1 Diabetes (Under Construction!)


My web page tracking research for a cure of type 1 diabetes: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials

There has been big news in Type-1 diabetes cure research in the last month or so. Here are the highlights:



These guys are starting a large scale Phase III trial, right on the heels of a successful Phase II trial. This is very good news for their cure. The down side here, is that it will probably take 2 years to find out how well it works. (9 months to recruit the 600 subjects, alone.) However, it is still unclear (at least to me) how complete a cure this is, and how many people will be able to benefit from it. You can read some of my discussion of earlier research here: http://joshualevy.pbwiki.com/MyDiamydPhase2Discussion



Finally, after a 10 year political delay, LCT is starting with a Phase I trial of their encapsulated porcine cell cure. The current Phase I trial is tiny (only 6 people) and run in Russia. They are hoping to start a Phase I trial in New Zealand very soon.


Transition Therapeutics

Their Phase II trial is ongoing, but they announced some early results which showed the treatment lowered insulin requirements by 20% in most people, and lowered H1c numbers as well. This is a combination therapy of a selective growth factor and gastrin that can regenerate the body's own insulin-producing cells (islet beta cells in the pancreas). This is a "short course" of drug therapy.




In many ways, Diamyd and LCT are in the exact opposite possitions in their path to a cure. Diamyd is one phase away from distribution and is agressively starting a large clinical trial. However, their cure is not likely to work for everyone. It might be honeymoon only, or it might be only some people are helped during their honeymoon, or it may be that only some people are helped and most of them are in their honeymoon phase. Furthermore, the Diamyd cure (as tested in their Phase II trial) is not a complete cure: it lowers insulin use considerably, but insulin is still required. LCT, on the other hand, is just starting a tiny Phase I trial. However, there is great hope that their treatment will work on almost any diabetic, and may remove the need to use insulin entirely.


However this is not an apples to apples comparison, in two ways. First, the Dyamid cure may improve with more testing, so that it becomes a complete replacement for insulin. Second, the LCT may turn out during Phase I or II to only really be a partial cure (much as Dyamid is now).


It is also interesting to compare LCT to various companies that are trying to cure diabetes by using human encapsulated beta cells, rather than LCT's porcine (pig) encapsulated beta cells. Amcyte and NovoCell are both almost a year into Phase 1 trials of human encapsulated cells.


To the best of my knowledge no other compound has started Phase III trials in a serious attempt to cure type 1 diabetes. The closest is P277 which has gone through 3 or more different Phase II trials (the first in 2001), but I don't know that the company has ever tried to start a phase III trail.


I think the absolutely most optimistic outcome of this crop of research is that in 2 or 4 years the Diamyd treatment becomes widely available, and that it's use greatly lowers the long term complications of living with type 1 diabetes, so that the average live span of a type 1 diabetic is much closer to the average livespan in general.


After that, things become very hard to predict. Amcyte and NovoCell (human encapsulated beta cells) are at least a year ahead of LCT (pig encapsulated beta cells). Will enough human cells be available? If not, will stem cells fill the gap? The pig cells will be plentiful, but will xeno transplantation create problems (either real of imagined?) Maybe one of the drug options (there are at least four in human trials) will "grow into" a complete cure, or maybe two of them working together will. Maybe a beta cell growth stimulator coupled with a immune system supressor? The future is still too far away for me to guess.


As usual, there is a lot of research that I didn't have time to discuss in this update.

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