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Randomized, controlled trial to evaluate efficacy
-
MGN1703 expanded by a further indication with high unmet medical need
BERLIN, Germany I October 28, 2013 I MOLOGEN AG has submitted a clinical trial application with MGN1703 in small-cell lung cancer to the competent authority in Belgium. The trial application will also be submitted shortly to the authorities in Germany and Austria as well as to the responsible ethics committees.
The study is designed as an open-label, two-arms, randomized, controlled and multi-center study. The aim of the study is to evaluate the efficacy and safety of MGN1703 in extensive disease small cell lung cancer. Primary endpoint is overall survival. It is anticipated that patient recruitment will be started in the first quarter of 2014, directly after receipt of the necessary approvals. Principal investigator is Prof. Dr. med. Michael Thomas, oncologist and Head of the Thoracic Oncology Department in the Thorax Clinic at the University Clinic Heidelberg. In Germany, the study will be conducted in collaboration with the „Aktion Bronchialkarzinom e.V.“ (ABC group) – a renowned German oncologists network of lung cancer specialists.
About the IMPULSE small cell lung cancer trial
The study with the title “Randomized Clinical Study of Maintenance Therapy with immunomodulator MGN1703 in Patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy” (IMPULSE study) will determine overall survival as primary endpoint. The trial will compare MGN1703 versus best standard of care. The study will include patients who are suffering from an extensive disease stage of small cell lung cancer (SCLC) and whose tumors have responded to first line therapy with chemotherapeutics. Treatment with MGN1703 is to commence after completion of the first line therapy and will continue until renewed progression of the cancer disease. It is planned to enroll approx.110 patients in the study.
About the ABC group (“Aktion Bronchialkarzinom e.V.”)
The ABC group is an association of more than 60 clinics and oncologists in Germany. The group members perform clinical studies for 12 years now to optimize therapies for patients with lung cancer and contribute to improving patients’ life. A well-organized dialog among the specialists ensures that studies are carried out in accordance with most modern insights.
About small cell lung cancer
Lung cancer is one of the most common cancer diseases. The two main types are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). SCLC is a fast-growing type of lung cancer that usually spreads more quickly than NSCLC.
In the US the estimated number of new lung cancer cases per year is 228,000 and in Europe it is 410,000. The estimated number of deaths per year is 159,000 in the US and 353,000 in Europe. The proportion of small cell lung cancer is approximately 15-20% of all lung cancer cases. When first diagnosed approx. 60-80% of the SCLC-patients have already distant metastases or extensive local involvement. This advanced stage is called “extensive disease”. The five-year survival rate for such patients is below 1%.
About MGN1703
MGN1703 is based on dSLIM® (“double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA 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 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: 227
-
Randomized, controlled trial to evaluate efficacy
-
MGN1703 expanded by a further indication with high unmet medical need
BERLIN, Germany I October 28, 2013 I MOLOGEN AG has submitted a clinical trial application with MGN1703 in small-cell lung cancer to the competent authority in Belgium. The trial application will also be submitted shortly to the authorities in Germany and Austria as well as to the responsible ethics committees.
The study is designed as an open-label, two-arms, randomized, controlled and multi-center study. The aim of the study is to evaluate the efficacy and safety of MGN1703 in extensive disease small cell lung cancer. Primary endpoint is overall survival. It is anticipated that patient recruitment will be started in the first quarter of 2014, directly after receipt of the necessary approvals. Principal investigator is Prof. Dr. med. Michael Thomas, oncologist and Head of the Thoracic Oncology Department in the Thorax Clinic at the University Clinic Heidelberg. In Germany, the study will be conducted in collaboration with the „Aktion Bronchialkarzinom e.V.“ (ABC group) – a renowned German oncologists network of lung cancer specialists.
About the IMPULSE small cell lung cancer trial
The study with the title “Randomized Clinical Study of Maintenance Therapy with immunomodulator MGN1703 in Patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy” (IMPULSE study) will determine overall survival as primary endpoint. The trial will compare MGN1703 versus best standard of care. The study will include patients who are suffering from an extensive disease stage of small cell lung cancer (SCLC) and whose tumors have responded to first line therapy with chemotherapeutics. Treatment with MGN1703 is to commence after completion of the first line therapy and will continue until renewed progression of the cancer disease. It is planned to enroll approx.110 patients in the study.
About the ABC group (“Aktion Bronchialkarzinom e.V.”)
The ABC group is an association of more than 60 clinics and oncologists in Germany. The group members perform clinical studies for 12 years now to optimize therapies for patients with lung cancer and contribute to improving patients’ life. A well-organized dialog among the specialists ensures that studies are carried out in accordance with most modern insights.
About small cell lung cancer
Lung cancer is one of the most common cancer diseases. The two main types are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). SCLC is a fast-growing type of lung cancer that usually spreads more quickly than NSCLC.
In the US the estimated number of new lung cancer cases per year is 228,000 and in Europe it is 410,000. The estimated number of deaths per year is 159,000 in the US and 353,000 in Europe. The proportion of small cell lung cancer is approximately 15-20% of all lung cancer cases. When first diagnosed approx. 60-80% of the SCLC-patients have already distant metastases or extensive local involvement. This advanced stage is called “extensive disease”. The five-year survival rate for such patients is below 1%.
About MGN1703
MGN1703 is based on dSLIM® (“double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various receptors on certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells and TAA 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 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: 227
