STOCKHOLM, Sweden, March 19 /PRNewswire-FirstCall/ -- Diamyd Medical (OMX: DIAM B)announced today that the Swedish Medical Products Agency (MPA) has approved the Company’s application to commence Phase III studies with the therapeutic diabetes vaccine Diamyd(R).
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“I am extremely glad that we now can offer our recently diagnosed type 1 diabetes patients the possibility to participate also in the European study,” says Professor Johnny Ludvigsson, Linkoping, Sweden, Principal Investigator for the study.
Diabetes teams from approximately 20 Swedish pediatric clinics will meet in Linkoping, Sweden on April 4 to go through details for the study, which will comprise 306 new onset type 1 diabetes patients. Diamyd Medical is planning to file clinical trial applications in another 3-4 European countries and include additionally 20 clinics in the study.
“The approval from the Swedish MPA is another important step in the development of Diamyd(R) towards the market,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “Last week we received authorization from the FDA to start a parallel Phase III trial in the US, and together with TrialNet’s planned study in the US, the interest in Diamyd is strong. We receive daily inquiries from parents of patients wanting to participate in our studies.”
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Disclaimer: This document contains certain statements relating to the progress, timing and completion of our research, development and clinical trials. These statements can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to publicly update such statements, whether because of new information, future events or otherwise, nor does Diamyd Medical give any guarantees that the statements, given or implied, are correct. This document is a translation from the Swedish original. No guarantees are made that the translation is free from errors.
CONTACT: For further information, please contact: Stockholm office:
Elisabeth Lindner, CEO and President, +46-8-661-0026,
elisabeth.lindner@diamyd.com Chairman; Stockholm office: Anders
Essen-Möller, +46-8-661-0026, anders.essen-moller@diamyd.com. Diamyd
Medical AB (publ). Linnégatan 89 B, SE-115 23 Stockholm, Sweden.
