DGAP-News: MOLOGEN AG/ Key word(s): Study MOLOGEN AGcompleted planning for clinical study with MGN1703 in small cell lung cancer 10.10.2013/ 08:00 --------------------------------------------------------------------- MOLOGEN AGcompleted planning for clinical study with MGN1703 in small cell lung cancer - Application of MGN1703 expanded by a further indication with high unmet medical need - Randomized, controlled trial to evaluate efficacy - Study will be conducted in collaboration with the German ABC group Berlin, October 10, 2013- MOLOGEN AGhas completed the planning for a clinical trial with MGN1703 in small-cell lung cancer. The trial application shall shortly be submitted to the competent authorities and ethics committees in Germany, Austriaand Belgium. The study is designed as an open-label, two-arms, randomized and multi-center study. The aim of the study is to evaluate the efficacy and safety of MGN1703. Primary endpoint is overall survival. This trial will replace the trial application submitted in 2012. The study will include patients who are suffering from an extensive disease stage of small cell lung cancer (SCLC) and whose tumors have responded to first line therapy with chemotherapeutics. Treatment with MGN1703 is to commence after completion of the first line therapy and will continue until renewed progression of the cancer disease. It is anticipated that patient recruitment will be started in the first quarter of 2014, directly after receipt of the necessary approvals. Principal investigator is Prof. Dr. med. Michael Thomas, oncologist and Head of the Thoracic Oncology Departmentin the Thorax Clinicat the University Clinic Heidelberg. In Germany, the study will be conducted in collaboration with the 'Aktion Bronchialkarzinom e.V.' ( ABCgroup) - a renowned German oncologists network of lung cancer specialists. Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AGcomments 'After the extensive analyses of our successful IMPACT colorectal cancer trial we have now designed an optimized trial with MGN1703 in small cell lung cancer. This trial is an important step to expand the potential application of MGN1703 by a further indication. We are very much looking forward to starting this trial soon.' Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AGadded, 'This disease is a heavy burden for patients since after first line therapy there are only very limited treatments available. We hope that MGN1703 may become an effective option in such unmet medical need. We are particularly pleased to work with Prof. Dr. Thomas, a renowned expert in the field of small cell lung cancer, and the ABCgroup.' About the ABCgroup ('Aktion Bronchialkarzinom e.V.') The ABCgroup is an association of more than 60 clinics and oncologists in Germany. The group members perform clinical studies for 12 years now to optimize therapies for patients with lung cancer and contribute to improving patients' life. A well-organized dialog among the specialists ensures that studies are carried out in accordance with most modern insights. Commenting on the clinical study of MGN1703 in small cell lung cancer, Prof. Dr. med. Martin Wolf, Kassel, Chairman of the ABCgroup said, 'This trial is very interesting for us because MOLOGENis exploring an innovative therapeutic approach to which we attribute great potential.'