The Berlin biotech company Mologen has received approval from the competent German and Austrian health authorities at the Paul Ehrlich Institute and the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen), respectively, to conduct a phase-2 study on the cancer drug MGN1703. MGN1703 is a DNA-based immunomodulator, which is being developed for DNA immunotherapy in patients with metastasized tumour diseases. After the cancer drug already demonstrated excellent tolerability in the phase-1b study, this phase-2 study will now investigate the efficacy of the drug in the treatment of metastatic colorectal cancer.

The clinical study is supposed to begin soon at several study centers in Germany and Austria. Professor Hans-Joachim Schmoll, director of the Halle University Hospital and Polyclinic for Internal Medicine IV, will act as the study coordinator. The study will be initiated as soon as the responsible Ethics Committees have issued their approval, which is anticipated to occur by March.

Additional study centers shall begin enrolment in Great Britain, Russia, and other countries as soon as the conduct of the study has been approved there.

“We are optimistic that MGN1703 can help patients by delaying the progression of cancer diseases for longer periods than has been possible up to now with other cancer drugs,” according to professor Burghardt Wittig, chairman of the Scientific Advisory Board and Co-founder of Mologen. “After a long way through the fundamental research phase, preclinical developments, and an initial, very successful phase-1b study, our dSLIM DNA molecule will now be put to its most significant clinical test yet.”

“In 2009 we were already able to prove the safety and excellent tolerability of MGN1703. The approval of this phase-2 study for MGN1703 is another triumph for Mologen,” said Dr Matthias Schroff, CEO of Mologen AG. “We are thrilled that the investigators will soon be able to begin treatment of the first patients.”

The phase-2, randomized, placebo-controlled, double-blind, multicenter clinical study (IMPACT study) is designed as a licensing-relevant confirmatory study and is intended to verify the efficacy of MGN1703 with statistical significance. The primary objective of the study is to determine progression-free survival among patients with advanced colorectal cancer. Secondary study objectives include determining the overall survival of patients and collecting data on immunological and pharmacodynamic parameters. Initial evidence on the achievement of the study objectives is anticipated to become available in the form of an interim report as early as nine to ten months following the start of the study. The study could have an overall duration of up to three years.

MGN1703 is based on dSLIM (Double Stem Loop Immunomodulator), an innovative DNA-based TLR9 agonist developed by Mologen.

Mologen AG, a biopharmaceutical com-pany based in Berlin, specializes in the research and development of innovative medicines based on DNA structures.