Martinsried/Munich, February 4, 2013. Medigene AG (Frankfurt, Prime Standard) announces that the Executive Board has decided, with the approval of the Supervisory Board, to expand the clinical development plan for RhuDex® in the treatment of autoimmune diseases. Following recommendations of the regulatory authorities and the Steering Committee, the planned phase IIa trial in the indication of primary biliary cirrhosis (PBC) is to be expanded from a three-arm to a four arm, controlled study and the planned treatment period for patients will be extended from three to six months. The aim is to increase the information value of the trial data collected in order to confirm the mode of action of RhuDex® in autoimmune diseases and facilitate the future approval of RhuDex® for PBC. This is expected to further increase the value of the drug candidate in both scientific and commercial terms.
Medigene will now develop the modified trial design. Subject to the successful completion of the necessary preparatory work and the approval of the study by the regulatory authorities, the start of this expanded phase II trial is scheduled for the first half of 2014 at the latest. It will replace the phase IIa trial with RhuDex® originally planned for 2013. As a result, the major financial expenses relating to a phase II trial will be deferred to 2014 and thereafter.
For more information please see today's press release at www.medigene.com/press
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