Mologen AG announced that it has received first approvals from the countries participating in the phase III pivotal trial IMPALA. The company expects the first patient in the study (FPI) in the third quarter 2014. The trial is investigating the efficacy of the immunotherapy MGN1703 to improve overall survival (OS) in patients with metastatic colorectal carcinoma.

MOLOGEN initiated the approval process for the IMPALA trial in the second quarter of 2014. Study applications were submitted to the corresponding authorities in eight European countries, including the five major pharma markets. As expected, first approvals have been obtained in the meantime.

The company assumes to start patient recruitment in the course of the third quarter 2014, as planned. IMPALA is a randomized, international, multicenter and controlled phase III trial. Patients to be enrolled must have achieved a response during their first line treatment of metastatic colorectal cancer.

The study aim is to prove that a switch maintenance therapy with the cancer immunotherapy MGN1703 leads to an increased overall survival. The study will include approximately 540 patients from more than 100 European centers.