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PRESS RELEASE N 8 / 2013 of 09/24/2013

MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to the FDA

* Investigational New Drug (IND) application for the treatment of solid tumors * Phase I clinical study in the U.S. to determine cardiac safety of MGN1703

Berlin, September 24, 2013 - MOLOGEN AG filed an Investigational New Drug (IND) application for MGN1703 with the U.S. Food and Drug Administration (FDA) to initiate a phase I clinical trial. The placebo-controlled, double-blind study is designed to determine the cardiac safety of MGN1703 and to evaluate pharmacokinetic parameters in healthy volunteers. The trial is expected to start as soon as the FDA has granted its approval.

Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG stated, 'With the IND application we are preparing the ground to develop our lead drug candidate MGN1703 for the treatment of solid tumors also in the USA. After the very promising final results of the IMPACT trial presented earlier this year we are now very much looking forward to proceeding with our clinical development program for MGN1703.'

MGN1703 has already successfully completed a phase II study in metastatic colorectal cancer (mCRC) in Europe. MOLOGEN is currently also preparing a pivotal study in mCRC and a phase II study in lung cancer for MGN1703. In parallel licensing activities for MGN1703 are ongoing.

About IMPACT study with MGN1703

The IMPACT study was a phase II, randomized, placebo-controlled, double-blind, multicenter clinical study to determine the efficacy of MGN1703 as maintenance therapy following first-line chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer.

Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months. During the study, patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was detected. Overall 59 patients were enrolled in the study. Patients' characteristics were globally balanced between treatment groups.

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DGAP-News: MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to the FDA