Clinical Trials

* On April 28, 2014, Mologen has announced the final data of the U.S. phase I study for MGN1703 in healthy volunteers. The primary objectives of the study were to investigate the cardiac safety and the pharmacokinetics of MGN1703. The final data confirmed the positive trend of the preliminary data on cardiac safety and tolerability, presented in December 2013 (See below). No significant side effects were observed. The final results demonstrated that the drug candidate MGN1703 was safe and well tolerated. The results also show that MGN1703 has a favorable pharmacokinetic profile and leads to consistent immune activation. The outcome of this study adds to the evidence collected so far with regard to the mechanism of action, efficacy and safety of MGN1703. Mologen looks forward to starting a phase III study in colorectal cancer in the second half of this year.
MGN1703 has successfully completed a phase II study in metastatic colorectal cancer  in Europe. Based on these results, Mologen is currently preparing an international pivotal study in metastatic colorectal cancer. In addition, a randomized controlled trial to assess the efficacy of MGN1703 in small cell lung cancer has already been started to extend the scope of the MGN1703 development program.

* On December 9, 2013, Mologen has announced that 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.

* On November 20, 2013, Mologen has announced that the first subject has been enrolled to the clinical trial phase I for MGN1703 in the U.S. It is planned to recruit 14 healthy volunteers and to finalize the study before the end of this year. MOLOGEN expects that first results will become available in early 2014.

* On October 23, 2013, Mologen has announced that the FDA and the responsible Institutional Review Board have approved the phase I clinical trial with MGN1703. The placebo-controlled, double-blind study determines the cardiac safety of MGN1703 in healthy volunteers which is an important safety aspect for the FDA. Together with further pharmacokinetic parameters the study will complete the already comprehensive data on tolerability and forms the basis for the further development of MGN1703 in the U.S. until market approval.

* On September 25, 2013, Mologen has announced that it has filed an Investigational New Drug (IND) application for MGN1703 with the 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. 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.