The Swedish Medical Products Agency approves new treatment arm with Remygen® and Alprazolam in Phase I/II trial ReGenerate-1
The approval by the Swedish MPA entails that ReGenerate-1, with Diamyd Medical's GABA-based investigational drug Remygen®, will be expanded from the original two treatment arms encompassing Remygen® administration, with a third treatment arm in which 12 patients receive Remygen® in combination with the GABA receptor modulator Alprazolam.“The Agency's positive decision is very gratifying and gives us as the first group in the world the opportunity to evaluate this combination in a clinical trial,” says Per-Ola Carlsson, Professor at Uppsala University and Uppsala University Hospital, Sponsor