News about Diamyd GAD65 Phase III Trials

[MegRyan]

This just in today.

"Phase III studies have been approved and initiated in Sweden and the US,
and approvals are expected from a number of European countries in August
and September. Inclusion of patients is ongoing in Sweden and ethics
approvals for participating US sites have started to come in."

"To date, all pursued and planned clinical trials with Diamyd® concern
patients diagnosed with type 1 diabetes or LADA. The Chairman of
TrialNet, Professor Jay Skyler, communicated during the ADA conference
in San Fransisco on 9th of June, that in addition to the planned
intervention study with 126 patients, a prevention study with Diamyd® in
healthy individuals at risk to develop type 1 diabetes is planned."

Not sure what sites are recruiting for the Diamyd Phase III trials, it's at least 20 sites according to the CEO.

For newly diagnosed this is really good news, and non-invasive (4 injections 4 weeks apart).

For not so newly diagnosed it might still be a step in the right decision.

/co-author
http://diamyd.blogspot.com/

[MegRyan]

Just a note for all who are doing the TrialNet screening.

Knowing if you have elevated GAD65 autoantibodies can be a good thing.

At the moment you can not prevent the outbreak of D, even if you know you have a 70% risk of getting it. But within a few years different treatments may be out which stops the autoimmune reaction. In that case you would want to get that treatment as soon as it's available.

Normally children are dx when they have 10-20% of the beta cells remaining. If you can dx earlier the potential future treatments might work better.