Trialnet starts trial using Diamyd vaccine

Trialnet will start the Diamyd Phase II trial at 15 clinics in the US.
This study will include 126 patients and add to the data planned to be received by the Phase III trials currently ongoing in the US and Europe, and the Combination trial mentioned earlier also supported by the NIH/NIDDK.

The group of 126 patients will be placebo controlled and given 3 injections of either GAD65 or Placebo. To be included in this trial you have to be newly diagnosed (3 months) and be within 16 - 45 years old.

After a while the age requirement will drop to 8 years and at the end of the trial probably even down to 3-4 years of age. This acceptance of very low ages is made to accommodate for the Trialnet prevention trial planned to start this year.

Recruitment is planned to take 6-9 months and first results can be expected in the first half of 2011 (we have Phase III results in fall of 2010).

Trialnet Chair Dr Skyler has the following to say:
"We are pleased to announce the launch of this trial, which will employ state-of-the-art technology to investigate the vaccine's modulation of the immune system to induce immune tolerance in type 1 diabetes. We look forward to studying the vaccine's effect and mechanism of action at TrialNet's 15 clinical centers in North America,"

This trial is another step on the way to secure that Diamyd (GAD65) is effective in slowing down or completely stopping the auto-immune reaction which destroys the beta cells.

Safety
VERY important to hear that FDA will allow younger children to try out this drug. Don't get me wrong, i'm not for testing unproven drugs on children, but for me this proves that Diamyd indeed has a strong safety profile. Compare to for example to TolerX, DiaPep and Macrogenics (teplizumab) who all have a range of side effects.

In less than 2 years we will get first data from Phase III trials. Then more data will continue to drop in as the patients are followed for a few more years. If results in Phase III trials looks as good as Phase II results published in NEJM, the drug can be on the market early 2012.

I'm hopeful and glad that we have this range of trials so results will be definitive.

If you want to read about other possible cures for T1D, I recommend cureresearch4type1diabetes by Joshua Levy.