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MOLOGEN AG: IMPULSE study with MGN1703 in small cell lung cancer started

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

24.03.2014 / 08:00

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MOLOGEN AG: IMPULSE study with MGN1703 in small cell lung cancer started

* Trial open for recruitment in Belgium
* First patient currently being screened

Berlin, March 24, 2014 - MOLOGEN AG has obtained the approvals for the
IMPULSE lung cancer study from the competent authority and the responsible
ethics committee in Belgium. The trial has now been started and is open for
recruitment. A first patient has signed the informed consent and is
currently being screened. With this study MOLOGEN aims to expand the
potential application of the cancer immune therapy MGN1703 by a further
indication with high unmet medical need.

The study protocol has also been submitted to the authorities and ethics
committees in Austria and Germany. The approvals in these countries have
not been obtained yet but are expected during the second quarter.

The randomized controlled two-arm multicenter and multinational trial
evaluates the efficacy and safety of MGN1703 for the treatment of extensive
disease small cell lung cancer. Coordinating 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 study
The trial 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 after four cycles of standard first
line therapy with chemotherapeutics. It is planned to screen approximately
110 patients in order to enroll 100 patients in the study. Eligible
patients randomized to the experimental arm will receive treatment with
MGN1703 until renewed progression of the cancer disease.

About small cell lung cancer
Lung cancer is one of the most common cancer diseases. The two main types
are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).