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    DGAP-News  535  0 Kommentare MOLOGEN AG presented subgroup analysis from IMPACT study and design of pivotal IMPALA trial at Gastrointestinal Cancers Symposium 2015 - Seite 2



    Patients included in the IMPACT study had stabilization, or partial or
    complete remission of their disease after receiving first-line therapy for
    4.5 to 6 months. The patients were randomized to receive either MGN1703 or
    placebo twice per week. The treatment was continued until tumor progression
    was observed. The primary endpoint of the study was to determine
    progression-free survival of the patients. Secondary study endpoints
    included overall survival, progression-free survival from start of
    induction therapy, response rates and safety, as well as collection of
    immunological and pharmacodynamic data.

    About IMPALA
    IMPALA is a randomized, international, multicenter, open-label phase III
    trial. The study aims to prove that a switch maintenance therapy with an
    active immunotherapy leads to an increased overall survival of patients who
    have achieved a response during their first line treatment of metastatic
    colorectal cancer. The primary endpoint is overall survival and secondary
    study endpoints include progression-free survival, toxicity and safety, and
    Quality of Life (QoL). Approximately 540 patients from more than 100
    European centers, including the five major pharma markets, will participate
    in the study. IMPALA started to treat the first patients in mid-September.

    Leading medical associations will collaborate: Arbeitsgemeinschaft
    Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de
    Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire
    en Oncologie (GERCOR) in France. The steering committee consists of
    international medical experts; among others the coordinating study
    investigators Prof. David Cunningham, MD, Department of Medicine and
    Director of Clinical Research, Royal Marsden Hospital in London, and Prof.
    Dirk Arnold, MD, Director of the Clinic for Medical Oncology, Klinik für
    Tumorbiologie, Freiburg, Germany.

    For more information on the trials IMPACT and IMPALA please visit
    www.clinicaltrials.gov.

    About MGN1703
    MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN. It
    broadly activates the immune system. This activation can be utilized to
    enable the immune system to better recognize and combat cancer cells. Due
    to this mechanism of action, MGN1703 can be applied to different
    indications of cancer.

    MOLOGEN AG
    MOLOGEN AG is a biotechnology company specialized in the research and
    clinical development of cancer immune therapies and DNA vaccines against
    infectious diseases.

    The cancer immune therapy MGN1703 is the company's lead product and
    best-in-class TLR9 agonist. It is currently developed for first-line
    maintenance treatment of colorectal cancer (pivotal randomized trial) and
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    DGAP-News MOLOGEN AG presented subgroup analysis from IMPACT study and design of pivotal IMPALA trial at Gastrointestinal Cancers Symposium 2015 - Seite 2 DGAP-News: MOLOGEN AG / Key word(s): Study/Study results MOLOGEN AG presented subgroup analysis from IMPACT study and design of pivotal IMPALA trial at Gastrointestinal Cancers Symposium 2015 19.01.2015 / 08:00 …