To my knowledge DiaPep 227 was the first potential cure for type-1 diabetes to go into phase-III human testing. That was back in 2005. However, there have always been troubling signs. For example, they finished their phase-II testing in 2001, but were not able to start phase-III trials for 4 years. (For comparison, both Diamyd and ToleRx went from phase-II to III in less than a year and a half.) For the last few years the only news I've seen is corporate. DiaPep 227 was sold first to one company, then to another, until it was finally owned by Andromeda.
Finally, in June 2008 the released interim results of their phase-III trials. You can read about them here, but you'll notice there are no numbers. No actual data results; they basically just said "did as well as phase-II testing" (although that is not an exact quote). Then one of their investors, who had seen the actual data dropped the following bombshell in a press release:
The reason is that the interim result does not provide statistically significant results about the effectiveness of DiaPep 277Basically, what they are saying is that -- so far -- the people treated with DiaPep 227 and the people who were not had about the same outcomes. That is the worst news you can get our of a clinical trial. Now all is not lost, maybe the end part of the phase-III trial will show great improvement. Maybe a future clinical trial will have success. However, right now, things look pretty grim.
Remember that treatments that are in phase-III trials generally have an 70% - 80% chance of going to market. So it is starting to look like DiaPep 227 is part of that 30% or 20% that gets to phase-III trials, but never gets to market. This is why research is a "numbers game" and I'm very happy to have both Diamyd and ToleRx in phase-III trials right now as well. (Although both of their cures are only being tested on honeymoon type-1 diabetics.)
I will continue to track news on DiaPep 227, but I'm not holding out much hope.
As always you can get updated on all the potential cures for type-1 diabetes on my web page: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials and read these updates on my blog: http://cureresearch4type1diabetes.blogspot.com/
6 comments:
see news 4 month after
http://www.globes.co.il/serveen/globes/docview.asp?did=1000410385&fid=942
Andromeda stated on Dec 24th, 2008 that an international independent expert committee notified it that Diapep277 was safe for use and improved the condition of patients treated. The committee recommends pursuing the trial as planned.
it time to change this post's header.
Teva invested 10.5 M US$
http://www.reuters.com/article/marketsNews/idINLI48804120090218?rpc=44
Considering Teva's significant investment in the company, it is possible that a review of the trial results revealed methodological problems which may have led to the less-than-stellar results. This is now in Phase III trials, although it remains to be seen whether this will result in anything or not.
I've put a more recent update on DiaPep227 here:
http://cureresearch4type1diabetes.blogspot.com/2009/06/update-on-andromedias-diapep227-money.html
which does reflect the new money Teva is investing. They have put a lot of money into DiaPep227 recently. However, as far as the science behind it, I have not seen anything new. If you learn of anything, please tell me!
Joshua Levy
I had the opportunity to take part last year in diapep227, though it was still in phase II, phase III would start in 2010 I was told.
Due to the fact that only 50% of the participants get the real stuff and the other 50% get a placebo, I backed out.
Meanwhile to come to my final decision, I did email TEVA's investor relations and did hear nothing from them. Also the fact that Teva owns the commercial rights of this product did not make me feel very safe as I was wondering why such a product would be a generic immediatelly.
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