Phase I trial to evaluate safety and tolerability
Trial is under supervision of Charité – Universitaetsmedizin Berlin
BERLIN, German I October 18, 2013 I The phase I clinical trial with the cancer immune therapy MGN1404 has been started. The trial evaluates the safety and tolerability of MGN1404 for the treatment of malignant melanoma. Furthermore data on the mechanism of action will be collected. MGN1404 will be applied in different dosages needle-free by jet-injection into skin metastases. It is planned to overall enroll nine patients in the trial. The study is a translational project for non-viral gene therapy and will be conducted by Charité in collaboration with Charité Comprehensive Cancer Center (CCCC), Experimental and Clinical Research Center (ECRC), Max Delbrueck Center for Molecular Medicine Berlin-Buch (MDC) as well as Skin Cancer Center Charité (SCCC). Principial investigator is Dr. med. Felix Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center Charité and scientific coordinator is Prof. Wolfgang Walther, ECRC, Charité.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, “With this study the third drug candidate from our broad pipeline of cancer immune therapies is entering the clinical development phase. I am especially glad that the longtime collaboration with the Max Delbrueck Center for Molecular Medicine, one of the best German institutes in the field of molecular biology, has now led to this trial. MGN1404 is addressing a severe disease with high unmet medical need. We are looking forward to the outcome of the trial.”www.mologen.com
Additional information:
MGN1404 – MIDGE® vector for TNF-alpha expression
Tumor necrosis factor alpha (abbreviated TNF-alpha) is a signaling substance (cytokine) of the immune system. TNF-alpha can stimulate cell death and therefore has – in the case of application into the tumor – a direct antitumoral effect. It also leads to the sensitization of tumors toward other therapies, such as chemotherapy or radiation therapy.
MGN1404 is a minimalistic, non-viral DNA expression vector encoding for TNF-alpha, based on MOLOGEN’S proprietary MIDGE® platform technology. The needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE® vectors directly into the tumor cells. The expression of TNF-alpha is triggered there by the MIDGE® vectors aiming to induce cell death in the tumor.
Malignant melanoma
Malignant melanomas are one of the most malignant forms of skin cancer. The worldwide occurrence of malignant melanoma in the white population has increased continually and considerably in recent decades. Approximately 77,000 people in the USA and 100,000 people in Europe develop malignant melanoma each year. Despite the lack of symptoms and a relatively small size, melanomas can metastasize early in the lymph nodes and other organs. If diagnosed when there are already distant metastases the five-year survival rate is approximately 10-20%. Treatments of late stage malignant melanoma include chemotherapy, immunotherapy or radiation therapy.
About the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch
The MDC was formed in 1992 to convert the molecular research results into practice, for the prevention, diagnosis and treatment of diseases. The location in the Buch district of northeast Berlin, with its clinics, research institutes and biotechnology companies provides an excellent environment for interdisciplinary and patient-oriented cutting edge research. As a result, in recent years the MDC has developed into an internationally recognized research institute. Thomson Reuters thus ranks the MDC as the only German institution in its list of the world’s 20 best institutes in the field of molecular biology and genetics, in 14th place.
The MDC currently employs around 1,588 staff and visiting scientists. The MDC is 90% funded by the federal government and 10% by the State of Berlin. There is also third-party funding in the millions. 65 research groups work in three main research areas (cardiovascular and metabolic diseases, cancer, nervous system disorders and systems biology).
www.mdc-berlin.de
The Experimental and Clinical Research Center (ECRC)
As a joint facility of the MDC and Charité, the ECRC promotes cooperation between research scientists and clinical researchers. Here, laboratory findings are made available to patients as quickly as possible, new approaches for the diagnosis, prevention and treatment of cardiovascular and metabolic disorders, cancer, and neurological diseases are developed and promptly used on patients.
The ECRC provides an excellent environment for patient-oriented research, including clinical trials. This includes a growing number of university clinics that offer specialized advice for patients, a station specifically designed for clinical research, a clean room manufacturing facility for cellular immunotherapy, and access to modern methods of ultra-high field magnetic resonance imaging.
www.charite.de/forschung/forschungszentren/experimental_and_clinical_research_center_ecrc
The Charité Comprehensive Cancer Center (CCCC)
The purpose of the CCCC is to bring together clinical and academic oncology at the Charité, and thus continuously coordinate not only diagnostics, therapy, medical, psychological, social and after-care of patients but also the prevention and early detection of cancers.
For successful cancer treatment, the close cooperation of specialists from different fields is crucial from the onset of the disease. Recognition of this at the Charité resulted in the creation of a Comprehensive Cancer Center in 2008, one of the first comprehensive centers for tumors in Germany, to improve treatment results further.
The goal is to optimize close cooperation with local doctors and hospitals to the prospects for curing and caring for cancer patients.
All Charité locations with their various disciplines involved in tumor therapy are networked with the CCCC, to ensure interdisciplinary and comprehensive cancer patient care from the beginning. Under the umbrella of the CCCC, each patient will receive direct access to the latest national and international treatment strategies and therapeutic studies.
As a top oncological center the CCCC is supported by the German Cancer Aid (Deutsche Krebshilfe). It is a member of the Organization of European Cancer Institutes, and is certified by the German Cancer Society as an Oncological Center.
About MOLOGEN AG
MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company’s most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development.
With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies.
SOURCE: Mologen
Post Views: 163
Phase I trial to evaluate safety and tolerability
Trial is under supervision of Charité – Universitaetsmedizin Berlin
BERLIN, German I October 18, 2013 I The phase I clinical trial with the cancer immune therapy MGN1404 has been started. The trial evaluates the safety and tolerability of MGN1404 for the treatment of malignant melanoma. Furthermore data on the mechanism of action will be collected. MGN1404 will be applied in different dosages needle-free by jet-injection into skin metastases. It is planned to overall enroll nine patients in the trial. The study is a translational project for non-viral gene therapy and will be conducted by Charité in collaboration with Charité Comprehensive Cancer Center (CCCC), Experimental and Clinical Research Center (ECRC), Max Delbrueck Center for Molecular Medicine Berlin-Buch (MDC) as well as Skin Cancer Center Charité (SCCC). Principial investigator is Dr. med. Felix Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center Charité and scientific coordinator is Prof. Wolfgang Walther, ECRC, Charité.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, “With this study the third drug candidate from our broad pipeline of cancer immune therapies is entering the clinical development phase. I am especially glad that the longtime collaboration with the Max Delbrueck Center for Molecular Medicine, one of the best German institutes in the field of molecular biology, has now led to this trial. MGN1404 is addressing a severe disease with high unmet medical need. We are looking forward to the outcome of the trial.”www.mologen.com
Additional information:
MGN1404 – MIDGE® vector for TNF-alpha expression
Tumor necrosis factor alpha (abbreviated TNF-alpha) is a signaling substance (cytokine) of the immune system. TNF-alpha can stimulate cell death and therefore has – in the case of application into the tumor – a direct antitumoral effect. It also leads to the sensitization of tumors toward other therapies, such as chemotherapy or radiation therapy.
MGN1404 is a minimalistic, non-viral DNA expression vector encoding for TNF-alpha, based on MOLOGEN’S proprietary MIDGE® platform technology. The needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE® vectors directly into the tumor cells. The expression of TNF-alpha is triggered there by the MIDGE® vectors aiming to induce cell death in the tumor.
Malignant melanoma
Malignant melanomas are one of the most malignant forms of skin cancer. The worldwide occurrence of malignant melanoma in the white population has increased continually and considerably in recent decades. Approximately 77,000 people in the USA and 100,000 people in Europe develop malignant melanoma each year. Despite the lack of symptoms and a relatively small size, melanomas can metastasize early in the lymph nodes and other organs. If diagnosed when there are already distant metastases the five-year survival rate is approximately 10-20%. Treatments of late stage malignant melanoma include chemotherapy, immunotherapy or radiation therapy.
About the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch
The MDC was formed in 1992 to convert the molecular research results into practice, for the prevention, diagnosis and treatment of diseases. The location in the Buch district of northeast Berlin, with its clinics, research institutes and biotechnology companies provides an excellent environment for interdisciplinary and patient-oriented cutting edge research. As a result, in recent years the MDC has developed into an internationally recognized research institute. Thomson Reuters thus ranks the MDC as the only German institution in its list of the world’s 20 best institutes in the field of molecular biology and genetics, in 14th place.
The MDC currently employs around 1,588 staff and visiting scientists. The MDC is 90% funded by the federal government and 10% by the State of Berlin. There is also third-party funding in the millions. 65 research groups work in three main research areas (cardiovascular and metabolic diseases, cancer, nervous system disorders and systems biology).
www.mdc-berlin.de
The Experimental and Clinical Research Center (ECRC)
As a joint facility of the MDC and Charité, the ECRC promotes cooperation between research scientists and clinical researchers. Here, laboratory findings are made available to patients as quickly as possible, new approaches for the diagnosis, prevention and treatment of cardiovascular and metabolic disorders, cancer, and neurological diseases are developed and promptly used on patients.
The ECRC provides an excellent environment for patient-oriented research, including clinical trials. This includes a growing number of university clinics that offer specialized advice for patients, a station specifically designed for clinical research, a clean room manufacturing facility for cellular immunotherapy, and access to modern methods of ultra-high field magnetic resonance imaging.
www.charite.de/forschung/forschungszentren/experimental_and_clinical_research_center_ecrc
The Charité Comprehensive Cancer Center (CCCC)
The purpose of the CCCC is to bring together clinical and academic oncology at the Charité, and thus continuously coordinate not only diagnostics, therapy, medical, psychological, social and after-care of patients but also the prevention and early detection of cancers.
For successful cancer treatment, the close cooperation of specialists from different fields is crucial from the onset of the disease. Recognition of this at the Charité resulted in the creation of a Comprehensive Cancer Center in 2008, one of the first comprehensive centers for tumors in Germany, to improve treatment results further.
The goal is to optimize close cooperation with local doctors and hospitals to the prospects for curing and caring for cancer patients.
All Charité locations with their various disciplines involved in tumor therapy are networked with the CCCC, to ensure interdisciplinary and comprehensive cancer patient care from the beginning. Under the umbrella of the CCCC, each patient will receive direct access to the latest national and international treatment strategies and therapeutic studies.
As a top oncological center the CCCC is supported by the German Cancer Aid (Deutsche Krebshilfe). It is a member of the Organization of European Cancer Institutes, and is certified by the German Cancer Society as an Oncological Center.
About MOLOGEN AG
MOLOGEN AG is a publicly listed biotechnology company headquartered in Berlin and specializes in the research and clinical development of innovative drugs in the fields of oncology and infectious diseases. One of the company’s most important product candidates is the DNA immunomodulator MGN1703, which is being clinically developed for colorectal cancer and lung cancer. The cell-based cancer therapy MGN1601 for the treatment of renal cancer is also currently at the stage of clinical development.
With unique, patented technologies and innovative product developments, MOLOGEN is one of the leading biotechnology companies in the fields of DNA medicine and cell-based therapies.
SOURCE: Mologen
Post Views: 163
