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  • Ulf Hannelius

    CEO


    Box 7349, SE-103 90 Stockholm
    +46 8 661 00 26
    +46 8 661 63 68
    https://www.diamyd.com

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    The collected genetic and immunological insights support the possibility that we may be able to truly individualize the treatment.
    Ulf Hannelius, CEO
    Our top strategic priority is to prepare for a marketing application for Diamyd®
    Ulf Hannelius, CEO
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    Positive safety evaluation of Remygen® in high dose and in combination with Alprazolam gives the go-ahead for the continuation of the trial

    Following evaluation of safety data, an independent safety committee (DSMB) recommends the continuation of the investigator-initiated clinical trial ReGenerate-1, where Diamyd Medical's GABA-based study drug Remygen[®] is administered in combination with the GABA receptor modulator Alprazolam.The evaluation was performed on safety data from four study participants in the group receiving a high dose of Remygen[®] and four in the group receiving a high dose of Remygen[®] in combination with Alprazolam, all of whom received treatment for one month. DSMB identified no safety issues and

    Positive safety review of Remygen[®] gives clearance to start next part of Phase I/II trial in type 1 diabetes patients

    The initial safety and dose escalation part of the Phase I/II trial with Remygen[®] in type 1 diabetes patients, ReGenerate-1, has been completed. The safety data from the six patients included in this first part of the trial has been evaluated by an independent Data Safety Monitoring Board (DSMB) who recommends that the main study can start. Metabolic results from the now completed safety and dose escalation part are being compiled and will be presented later this year."We already have the first participants ready to enter the next part of the trial," says Per-Ola Carlsson, Professor at

    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

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