Wednesday, May 6, 2009

Quick Updates: Faustman, Diamyd, and LCT

Quick Update on Faustman
This is a very fluffy TV news segment on Faustman, with no new information in it, except that results of her human trials should be published "by 2010". Previously, the target was mid-2009, and before that, late 2008.

Discussion on Faustman
There is no way to know if this is bad news for the research or not, because there is no way of knowing the cause of the delay. Human trials are often delayed because it takes longer than expected to recruit people (a good reason), but sometimes they are delayed for more complex analysis required to see a small benefit, not seen in the quicker data analysis (a bad reason).

Quick Update on Diamyd{16C4F628-8E2A-4E83-B0FB-0A514E053449}&dist=msr_2
This is a five year follow up on Diamyd's phase-II clinical trial of their GAD65 treatment on LADA patients. Sometimes called "type 1.5" LADA is immunity based diabetes that effects older people. So the results seen here are likely to be relevant to type 1 diabetics. The results were good, especially in avoiding insulin use. The 47 patients got several different doses. The best dose seemed to be 20ug. At the start of the trial, none of the patients required insulin. For the 20ug dose, only 14% of the people required insulin after 5 years. For the no-dose group, 64% required insulin. Put another way, of the 11 people who did not get GAD65, 7 of them required insulin at the end of the study. Of the 7 people who got 20ug, only 1 did. The 20ug group, had very slightly better C-peptide numbers at the end of the trial than at the beginning, while the no-dose group had worse C-peptide numbers at the end. That suggests that the GAD65 prevented the destruction of beta cells.

Discussion on Diamyd
One of the big issues in type-1 cure research is this: If the immune system stops attacking it's own beta cells, will the body's beta cells naturally regrow without further help? This research suggests to me that the answer is no. C-peptide is created when the body makes insulin. If you look at the patient's C-peptide numbers, the no GAD group's declined, which is what you'd expect from an immune system continuing to attack the beta cells. However, in the groups that got the treatment, the C-peptide numbers basically stayed the same, not going up or down. That suggests that the beta cell attack stopped, but that no new beta cells were regenerated by the body.

Quick Update on LCT
LCT now has two patients who don't require external insulin right now.

Discussion on LCT
This is basically the same news we've heard before from LCT. Some people given their treatment do not require insulin for a few weeks or a few months. This is good news, to be sure, but it is the same news we already knew of their work. In my mind, the big issue with their cure is how long the implanted cells last, and I don' t think the data announced here addresses that issue.

A personal note: I'm in the middle of an internal transfer at work. This is something that I've wanted for a long time, but in the short term, it means less time to read and comment on research. When I first started this blog, I was hoping for about 2 postings per month, but April was much busier than that. But I doubt I'll have time to make as many postings in May and through the summer.



Llewellyn said...

There's a combination clinical trial that's planed using Diakine's Lisofylline and Kinexum's INGAP,do you know any details of this clinical trial?

Joshua Levy said...

This is the information I have on them now:

but I believe they have started a clinical trial, so I will try to get an update on that soon.

Joshua Levy