Andromeda Completes Patient Recruitment in Phase III Trials for DiaPep 227
Andromeda has announced that their phase-III clinical trial of DiaPep277 is fully enrolled. This is an important milestone, because it now means the end of the study can be predicted. Since their protocol is 2 years long, they will be data complete around September 2011. They have also said that they will have results at end of 2011, which makes sense.
DiaPep277 is the oldest Phase-III clinical trial that I know of. Previous news has not been good. Their intermediate results were lackluster and they changed their experimental design and recruited more patients. I've never gotten around to reviewing their Phase-II results (which were published prior to my interest in clinical trials), but maybe I should.
Press release: http://www.pipelinereview.com/index.php/2009090929254/Proteins-and-Peptides/Andromeda-Biotech-Successfully-Completes-Patient-Recruitment-in-Phase-III-Trials-for-its-Lead-Drug-DiaPep277-for-Type-1-Diabetes.html
4-Year Follow-up of Diamyd(r) Phase II Study Shows Clear Positive TrendDiamyd got permission to extend their Phase-II trial, and continue to follow the same group of patients for a total of 7 years. They talked about 4-year data in this way:
Since there are no actual numbers here, I wouldn't read too much into it. "Clearly better" is pretty vague. There is no reference to anything published, so there is no place to look for more details or actual numbers.Initial analysis of new data shows, that patients treated with the Diamyd(r) vaccine early after diagnosis have a clearly better diabetes status compared to the corresponding placebo group, still 4 years after the injections.
press release: http://www.reuters.com/article/pressRelease/idUS86571+03-Sep-2009+GNW20090903
Diamyd to include children over 10 yrs in US phase III study with Diamyd diabetes vaccineDiamyd got FDA approval to lower the minimum age of enrollment in their US Phase-III study down to 10. That's young for a clinical trial, and a sign that the FDA thinks that Diamyd's treatment is very likely to be very safe. For comparison, ToleRx can accept people as young as 12, and MacroGenics down to 18 (and even 8, but only with special approval).
press release: http://www.pharmabiz.com/article/detnews.asp?articleid=51470§ionid=
Faustman is Data Complete, Results by early 2010.
In 10-February 2009, the Nathan/Faustman group officially reported that they had enrolled the last patient into their Phase-I trials. They also updated their clinical trial record to show that they would be data complete in July 2009. (This makes sense, since the protocol only requires 3 months of data gathering after a patient starts.)
So, as of now, they should be working on analyzing the data, writing the paper, and getting it published. (And if we are lucky, getting reporters or bloggers to write about the results!)
They also have a facebook page which contains this quote:
"We hope to have all of the Phase I data submitted to our biostatistics center in ", and their lab web pages talks about having results by early 2010, so I think we are close to hearing about their results. Their just-released newsletter also has the "early 2010" date.