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. On the occasion of the publication of the Company's annual report on March 22, 2013, Medigene will provide further details of the development strategy for RhuDex® and the Company' s financial outlook.
Dr. Frank Mathias, Chief Executive Officer of Medigene AG explains: "The expanded trial may deliver findings of a higher quality regarding the clinical relevance of the mode of action of RhuDex® in the treatment of PBC and other autoimmune diseases, including rheumatoid arthritis. The medical need in PBC is high, and many patients are urgently awaiting the availability of a specific treatment regime. If the development is successful, RhuDex® may become the first disease modifying, causal treatment option in this indication."
About RhuDex: Medigene is developing RhuDex® as an oral, disease-modifying drug for the treatment of autoimmune diseases. RhuDex® is a CD80 antagonist that blocks undesired T-cell activation and thus has an immunomodulating and anti-inflammatory effect. Therefore, this drug candidate can be classified with the group of "Disease-Modifying Antirheumatic Drugs" (DMARDs). Medigene has successfully completed a phase IIa pilot study with RhuDex® in the indication rheumatoid arthritis.
About PBC: The autoimmune disease PBC is a chronic liver disease that initially affects the bile ducts. The bile ducts are progressively destroyed by inflammatory processes, causing biliary stasis and build-up of bile in the liver. Liver tissue is destroyed and replaced by connective tissue, liver cirrhosis develops. As in rheumatoid arthritis, the activation of T cells via a CD28-CD80 interaction has been described as involved in the pathogenesis of PBC, a process that is to be inhibited by RhuDex® treatment. PBC belongs to the orphan diseases, i.e. a group of rare and severe medical conditions. Under certain circumstances, the development, approval and marketing of drugs for the treatment of orphan diseases are supported by public subsidies.
Medigene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene was the first German biotech company to have revenues from marketed products, which are currently distributed by partner companies. The company has two drug candidates in clinical trials and is developing an innovative vaccine technology. For more information, please visit www.medigene.com.
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® and Veregen® are registered trademarks of Medigene AG. These trademarks may be owned or licensed in select locations only.
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