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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
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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