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MOLOGEN AG submitted clinical study with MGN1703 in small cell lung cancer

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG submitted clinical study with MGN1703 in small cell lung
cancer

28.10.2013 / 08:00

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MOLOGEN AG submitted clinical study with MGN1703 in small cell lung cancer

- Randomized, controlled trial to evaluate efficacy

- MGN1703 expanded by a further indication with high unmet medical need

Berlin, October 28, 2013 - MOLOGEN AG has submitted a clinical trial
application with MGN1703 in small-cell lung cancer to the competent
authority in Belgium. The trial application will also be submitted shortly
to the authorities in Germany and Austria as well as to the responsible
ethics committees.

The study is designed as an open-label, two-arms, randomized, controlled
and multi-center study. The aim of the study is to evaluate the efficacy
and safety of MGN1703 in extensive disease small cell lung cancer. Primary
endpoint is overall survival. 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 Department in the
Thorax Clinic at the University Clinic Heidelberg. In Germany, the study
will be conducted in collaboration with the 'Aktion Bronchialkarzinom e.V.'
(ABC group) - a renowned German oncologists network of lung cancer
specialists.

About the IMPULSE small cell lung cancer trial
The study with the title 'Randomized Clinical Study of Maintenance Therapy
with immunomodulator MGN1703 in Patients with Extensive Disease Small Cell
Lung Cancer after Platinum-Based First-Line Therapy' (IMPULSE study) will
determine overall survival as primary endpoint. The trial will compare
MGN1703 versus best standard of care. 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 planned to enroll approx.110 patients in the
study.

About the ABC group ('Aktion Bronchialkarzinom e.V.')
The ABC group 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