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PRESS RELEASE: MOLOGEN AG: Treatment phase of safety trial with MGN1703 in the U.S. completed

DGAP-News: MOLOGEN AG / Key word(s): Study MOLOGEN AG: Treatment phase of safety trial with MGN1703 in the U.S. completed

09.12.2013 / 08:01

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MOLOGEN AG: Treatment phase of safety trial with MGN1703 in the U.S. completed

Berlin, December 9, 2013 - The treatment phase of the clinical trial phase I for MGN1703 in the U.S. was finished according to plan. In terms of safety and tolerability no significant clinical events were observed to date. The study will be completed on schedule until year-end. MOLOGEN expects that first results will become available in early 2014.

The placebo-controlled, double-blind study evaluates the cardiac and general safety as well as pharmacodynamics of MGN1703 in healthy volunteers. The trial will add to the already comprehensive data package on tolerability and mechanism of action and forms the basis for the further development of MGN1703 in the U.S. until market approval.

MGN1703 has already successfully completed a phase II study in metastatic colorectal cancer (mCRC) in Europe. MOLOGEN is currently preparing a pivotal study in mCRC. In addition a randomized controlled trial to assess the efficacy of MGN1703 in small cell lung cancer has already been applied for to extend the scope of MGN1703.

About MGN1703 MGN1703 is based on dSLIM(R) ('double Stem Loop Immunomodulator'), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM(R) activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM(R), the immune system is able to overcome its fatal tolerance toward cancer cells and TAA and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.

About MOLOGEN AG MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company's most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development. With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies. MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.

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PRESS RELEASE: MOLOGEN AG: Treatment phase of safety trial with MGN1703 in the U.S. completed