Transition Therapeutics's TT-223 goes to the Boneyard
Transition Therapeutics is researching using a combination of two drugs to cause beta cell regrowth in an attempt to cure type-1 and type-2 diabetes. As of May 2009, they had officially marked their phase-I human trial for type-1 diabetes as closed. I haven't seen any published results for it, but I'm still looking. However, actions speak louder than words, and Eli Lilly (working with Transition Therapeutics) started a clinical trial in February 2009 using Transition Therapeutics's TT-223 product, but only for people with type-2 diabetes.
Also, in May 2009 they announced that JDRF and Transition Therapeutics had agreed that JDRF would stop funding clinical development of TT-223. Transition Therapeutics and JDRF terminated their agreement. Eli Lilly is taking over support for TT-223, but is applying the technology only to type-2 diabetes.
So the news from Transition Therapeutics for type-1 diabetics is not good. I will move Transition Therapeutics to my "boneyard" of research that has not panned out if there is no good news in the next 6 months.
This result is not too surprising, and is similar to previous results with INGAP: because type-1 diabetes is an autoimmune disease, simply regrowing new beta cells can not cure it. The immune system attacks the new beta cells the same as the old ones. This type of treatment has more direct applicability on type-2 diabetes, where more beta cells are more likely to be helpful. Of course, if any of the treatments currently being developed succeeds in ending the autoimmune attack, then treatments that regrow beta cells will suddenly be in high demand. Unless the body regrows beta cells naturally without intervention.
A few months after stopping the funding of TT-223, JDRF started funding a large, general program (together with Genomics Institute of the Novartis Research Foundation) to test generic drugs for their ability to help regrow pancreas cells. Although I don't have visibility into JDRF's decision making, I think it is reasonable to say that since TT-223 did not pan out, JDRF is putting money into other research with similar goals. Unfortunately, that research is not in human trials yet, so I won't be following it.
These are records for Transition Therapeutics's phase-I studies:
And here is the clinical trial record for their phase-II study (which is type-2 only):
I'd like to thank Susan Mohr for some of the information used here.
Alba's Lazotide (previously AT-1001) goes to the Boneyard for type-1 diabetes, but not Celiac Disease
I recently moved Alba Therapeutics's Larazotide (previously known as AT-1001) from my "preparing for clinical trials" section to my "boneyard" for treatments that are no longer under development as cures for type-1 diabetes.
I did this before reading the following Scientific American article:
That article (written by a founder of Alba Therapeutics) says that the FDA approved human trials for Larazotide for type-1 diabetes. However, I can not find any references at the company's web site that they are planning such a clinical trial, and there is nothing in www.clinicaltrials.gov, either. So therefore it is staying in the boneyard for now.
If you read the article linked above, remember that the author did some of the original research into Larazotide and founded Alba Therapeutics, so is not an unbiased source! In particular, this quote:
Surprisingly, essentially the same trio—an environmental trigger, a genetic susceptibility and a “leaky gut”—seems to underlie other autoimmune disorders as well. This finding raises the possibility that new treatments for CD may also ameliorate other conditions.This is the author's opinion, however I don't think it is general consensus among researchers. Most researchers believe that autoimmune disorders are built on a foundation of a genetic susceptibility and an environmental trigger. The idea that "leaky gut" underlies autoimmune disorders is a minority opinion. Of course, if Larazotide works the way Alba hopes it will, that might change.
All of the above comments pertain to using Larazotide for type-1 diabetes, not Celiac Disease. The situation for Celiac is much different: Alba is running human trials. There are several listed at www.clinicaltrials.gov, and I think some of them are phase-II. (But I don't follow Celiac closely so am unclear on the details. Also, there appear to be two different drugs called "AT-1001" and "AT1001" so don't get confused.)