Mologen AG: Successful Investigator Meetings For IMPALA Colorectal Cancer Trial
Berlin, October 20, 2014 – MOLOGEN AG, a biotechnology company focused on cancer immunotherapy, has organized the first set of investigator meetings for the phase III IMPALA study. Study teams from all eight countries where the trial will be conducted attended the seminars in Barcelona and Berlin. The aim was to allow investigators and study nurses from the participating clinical trial sites an intensive exchange of information, particularly in the context of the recent study initiation.
The pivotal phase III clinical trial IMPALA is designed as an open-label, two-arm, randomized, controlled multicenter study. The aim of the study is to evaluate the efficacy of the first-line maintenance treatment with MGN1703 in patients with metastatic colorectal cancer. The primary endpoint of the study is to determine patient overall survival. It is planned to include patients from more than 100 sites in eight European countries, including the five major European pharma markets. In addition, three renowned national cancer associations will participate in the IMPALA trial and contribute their specific expertise: 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 coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, MD, PhD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie (Tumor Biology Center), Freiburg, Germany. They are members of the international steering committee of the IMPALA study among other leading experts in gastrointestinal oncology in Europe.
The Chief Medical Officer of MOLOGEN, Dr. Alfredo Zurlo, stated, “We are very encouraged by the feedback and support from the participating clinical centers. The attendees valued the opportunity to share information on the results of the prior phase II IMPACT study of MGN1703 and their translation into the design of the IMPALA trial. IMPALA focuses on those patients who will more likely benefit from MGN1703 given as switch maintenance therapy in metastatic colorectal cancer.”
Further to the IMPALA trial in colorectal cancer, MGN1703 is being investigated for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, an international randomized controlled trial, is currently enrolling patients as well.
For more information of the IMPALA and IMPULSE trials, visit www.clinicaltrials.gov.
About IMPALA
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. Based on the findings from IMPACT, the study will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The study will include around 540 patients in eight European countries from more than 100 centers, including the five major European pharma markets.
The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL).
The coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, MD, PhD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie (Tumor Biology Center), Freiburg, Germany.
Members of the International Steering Committee: Prof. David Cunningham, UK; Prof. Dirk Arnold, MD, PhD, Germany; Prof. Michel Ducreux, France; Prof. Ramon Salazar, Spain; Univ.-Prof. Dr. Werner Scheithauer, Austria; Prof. Alberto Sobrero, Italy; Prof. Eric Van Cutsem, MD, PhD, Belgium; Prof Christophe Tournigand, France.
About MGN1703
MGN1703 is an innovative DNA-based TLR-9 agonist developed by MOLOGEN. It broadly activates the immune system against tumor-associated antigens (TAA) which are released by cancer cells. Once activated by MGN1703, the immune system is able to overcome its fatal tolerance toward cancer cells and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.
About 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 TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.
MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.
www.mologen.com
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)
MIDGE®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
MOLOGEN AG
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.
The pivotal phase III clinical trial IMPALA is designed as an open-label, two-arm, randomized, controlled multicenter study. The aim of the study is to evaluate the efficacy of the first-line maintenance treatment with MGN1703 in patients with metastatic colorectal cancer. The primary endpoint of the study is to determine patient overall survival. It is planned to include patients from more than 100 sites in eight European countries, including the five major European pharma markets. In addition, three renowned national cancer associations will participate in the IMPALA trial and contribute their specific expertise: 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 coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, MD, PhD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie (Tumor Biology Center), Freiburg, Germany. They are members of the international steering committee of the IMPALA study among other leading experts in gastrointestinal oncology in Europe.
The Chief Medical Officer of MOLOGEN, Dr. Alfredo Zurlo, stated, “We are very encouraged by the feedback and support from the participating clinical centers. The attendees valued the opportunity to share information on the results of the prior phase II IMPACT study of MGN1703 and their translation into the design of the IMPALA trial. IMPALA focuses on those patients who will more likely benefit from MGN1703 given as switch maintenance therapy in metastatic colorectal cancer.”
Further to the IMPALA trial in colorectal cancer, MGN1703 is being investigated for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, an international randomized controlled trial, is currently enrolling patients as well.
For more information of the IMPALA and IMPULSE trials, visit www.clinicaltrials.gov.
About IMPALA
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. Based on the findings from IMPACT, the study will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The study will include around 540 patients in eight European countries from more than 100 centers, including the five major European pharma markets.
The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL).
The coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, MD, PhD, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie (Tumor Biology Center), Freiburg, Germany.
Members of the International Steering Committee: Prof. David Cunningham, UK; Prof. Dirk Arnold, MD, PhD, Germany; Prof. Michel Ducreux, France; Prof. Ramon Salazar, Spain; Univ.-Prof. Dr. Werner Scheithauer, Austria; Prof. Alberto Sobrero, Italy; Prof. Eric Van Cutsem, MD, PhD, Belgium; Prof Christophe Tournigand, France.
About MGN1703
MGN1703 is an innovative DNA-based TLR-9 agonist developed by MOLOGEN. It broadly activates the immune system against tumor-associated antigens (TAA) which are released by cancer cells. Once activated by MGN1703, the immune system is able to overcome its fatal tolerance toward cancer cells and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.
About 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 TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.
With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.
MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.
www.mologen.com
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)
MIDGE®, dSLIM®, EnanDIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
MOLOGEN AG
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 – 86
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Help employers find you! Check out all the jobs and post your resume.