Trial open for recruitment in Belgium
First patient currently being screened
BERLIN, Germany I March 24, 2014 I MOLOGEN AG has obtained the approvals for the IMPULSE lung cancer study from the competent authority and the responsible ethics committee in Belgium. The trial has now been started and is open for recruitment. A first patient has signed the informed consent and is currently being screened. With this study MOLOGEN aims to expand the potential application of the cancer immune therapy MGN1703 by a further indication with high unmet medical need.
The study protocol has also been submitted to the authorities and ethics committees in Austria and Germany. The approvals in these countries have not been obtained yet but are expected during the second quarter.
The randomized controlled two-arm multicenter and multinational trial evaluates the efficacy and safety of MGN1703 for the treatment of extensive disease small cell lung cancer. Coordinating 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 study
The trial 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 after four cycles of standard first line therapy with chemotherapeutics. It is planned to screen approximately 110 patients in order to enroll 100 patients in the study. Eligible patients randomized to the experimental arm will receive treatment with MGN1703 until renewed progression of the cancer disease.
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 prognosis for extensive disease SCLC is still very poor: median overall survival is less than 12 months and only few patients survive for more than two years. Thus there is a high unmet medical need for new treatment options.
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 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.
SOURCE: Mologen
Post Views: 316
Trial open for recruitment in Belgium
First patient currently being screened
BERLIN, Germany I March 24, 2014 I MOLOGEN AG has obtained the approvals for the IMPULSE lung cancer study from the competent authority and the responsible ethics committee in Belgium. The trial has now been started and is open for recruitment. A first patient has signed the informed consent and is currently being screened. With this study MOLOGEN aims to expand the potential application of the cancer immune therapy MGN1703 by a further indication with high unmet medical need.
The study protocol has also been submitted to the authorities and ethics committees in Austria and Germany. The approvals in these countries have not been obtained yet but are expected during the second quarter.
The randomized controlled two-arm multicenter and multinational trial evaluates the efficacy and safety of MGN1703 for the treatment of extensive disease small cell lung cancer. Coordinating 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 study
The trial 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 after four cycles of standard first line therapy with chemotherapeutics. It is planned to screen approximately 110 patients in order to enroll 100 patients in the study. Eligible patients randomized to the experimental arm will receive treatment with MGN1703 until renewed progression of the cancer disease.
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 prognosis for extensive disease SCLC is still very poor: median overall survival is less than 12 months and only few patients survive for more than two years. Thus there is a high unmet medical need for new treatment options.
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 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.
SOURCE: Mologen
Post Views: 316
