BERLIN, Germany I April 15, 2013 I The Paul-Ehrlich Institute has granted approval for a phase I clinical study of a gene therapy with MGN1404 for the treatment of melanomas. The study is entitled “Phase I trial of TNF-alpha expressing MIDGE-vector non-viral gene transfer in skin metastases of melanoma.” The study will be conducted by collaborative partners Charité Comprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical Research Center of the Charité (ECRC), the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the Charité (Hauttumorcentrum, HTCC).
The study will examine whether the MIDGE® vector is safe and well tolerated when applied by intra-tumor jet injector, and whether the application leads to efficient expression of the hTNF-alpha gene. Further, the magnitude and extent of gene expression and the distribution of the MIDGE® vector within and outside the injected tumor will be examined. Three different doses of the MIDGE® vector will be used. This study is a first step towards the clinical use of local gene therapy for malignant melanomas.
www.mologen.com
Additional information:
MGN1404 – MIDGE® vector for the expression of TNF-alpha
Tumor necrosis factor-alpha (TNF-alpha) is a signaling molecule (cytokine) produced by the immune system. Among its effects, TNF-alpha can induce cell death, and thus has direct antitumor effects when applied to tumors. Furthermore, it leads to the sensitization of tumors to other therapies, such as chemotherapy or radiotherapy. MGN1404 is a MIDGE®-based (non-viral) expression vector. The needle-free intra-tumor jet injection of MGN1404 transports MIDGE® vectors directly into the tumor cells. There, the expression of TNF-alpha is triggered by the MIDGE® vector and cell death is induced in the tumor cells.
Malignant melanoma
Malignant melanoma of the skin is one of the most virulent forms of skin cancer. The incidence of malignant melanoma has shown a steady and significant increase worldwide in the Caucasian populations in recent decades. Every year in Germany, almost 14,000 people are diagnosed with malignant melanoma, including about 8,000 women and 6,000 men. The risk of developing melanoma later in life is about 1 in 50 in Germany, and 1 in 20 in Australia. Middle-aged individuals between ages 45 and 60 are frequently affected. Despite a lack of symptoms and relatively small size, melanomas can form metastases in the lymph nodes and other organs at an early stage.
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 non-small cell lung cancer. The cell-based cancer therapy MGN1601 for the treatment of advanced renal cancer (renal cell carcinoma) 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: 223
BERLIN, Germany I April 15, 2013 I The Paul-Ehrlich Institute has granted approval for a phase I clinical study of a gene therapy with MGN1404 for the treatment of melanomas. The study is entitled “Phase I trial of TNF-alpha expressing MIDGE-vector non-viral gene transfer in skin metastases of melanoma.” The study will be conducted by collaborative partners Charité Comprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical Research Center of the Charité (ECRC), the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the Charité (Hauttumorcentrum, HTCC).
The study will examine whether the MIDGE® vector is safe and well tolerated when applied by intra-tumor jet injector, and whether the application leads to efficient expression of the hTNF-alpha gene. Further, the magnitude and extent of gene expression and the distribution of the MIDGE® vector within and outside the injected tumor will be examined. Three different doses of the MIDGE® vector will be used. This study is a first step towards the clinical use of local gene therapy for malignant melanomas.
www.mologen.com
Additional information:
MGN1404 – MIDGE® vector for the expression of TNF-alpha
Tumor necrosis factor-alpha (TNF-alpha) is a signaling molecule (cytokine) produced by the immune system. Among its effects, TNF-alpha can induce cell death, and thus has direct antitumor effects when applied to tumors. Furthermore, it leads to the sensitization of tumors to other therapies, such as chemotherapy or radiotherapy. MGN1404 is a MIDGE®-based (non-viral) expression vector. The needle-free intra-tumor jet injection of MGN1404 transports MIDGE® vectors directly into the tumor cells. There, the expression of TNF-alpha is triggered by the MIDGE® vector and cell death is induced in the tumor cells.
Malignant melanoma
Malignant melanoma of the skin is one of the most virulent forms of skin cancer. The incidence of malignant melanoma has shown a steady and significant increase worldwide in the Caucasian populations in recent decades. Every year in Germany, almost 14,000 people are diagnosed with malignant melanoma, including about 8,000 women and 6,000 men. The risk of developing melanoma later in life is about 1 in 50 in Germany, and 1 in 20 in Australia. Middle-aged individuals between ages 45 and 60 are frequently affected. Despite a lack of symptoms and relatively small size, melanomas can form metastases in the lymph nodes and other organs at an early stage.
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 non-small cell lung cancer. The cell-based cancer therapy MGN1601 for the treatment of advanced renal cancer (renal cell carcinoma) 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: 223
