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28.06.2012

MOLOGEN AG is cooperating with Max Delbrück Centrum und Charité in clinical study on skin cancer

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Preparation for a phase I/II clinical study with MIDGE-based gene therapy of malignant melanom

MOLOGEN AG - Press Release N° 8/2012 of 06/28/2012

Berlin, June 28, 2012 - MOLOGEN AG and the Experimental and Clinical Research Center (ECRC) of CharitéUniversitätsmedizin Berlin, and the Max Delbrück Centrum für Molekulare Medizin, Berlin-Buch (MDC) (Center for Molecular Medicine) have finalized a cooperation agreement. At the initiative and under the aegis of Dr. Peter M. Schlag, director of the Charité Comprehensive Cancer Center (CCCC) and Dr. Wolfgang Walther of the ECRC, the safety and tolerance of a MIDGE®-based gene therapy are to be examined in the treatment of malignant melanoma as part of a clinical study planned at the Charité.

The initial objective of the cooperation is to carry out all of the necessary preparations for the clinical study and to submit an appropriate study application to the relevant authorities and ethics committee. The study will be performed at the Charité and directed by Prof. Dr. Schlag and Private Lecturer Dr. Uwe Trefzer (Skin Cancer Center of the Charité). The MDC will perform the molecular biological analysis of the data yielded by the clinical study. MOLOGEN AG will support the partners in preparing the study application and, as holder of the patent for the underlying MIDGE® platform technology, is responsible for producing the medicinal product MGN1404 under investigation.

Prof. Dr. med. Dr. h.c. Peter M. Schlag, Charité Comprehensive Cancer Center (CCCC) in Berlin: "I hope for further progress in the treatment of cancer derived from the innovative therapy that was tested in preclinical studies in collaboration with Private Lecturer Dr. Walther of the ECRC and MOLOGEN AG. The cooperation is also further proof of the extensive know-how and innovative strength of medical research in Berlin, on the part of both academic institutions and companies located here."

Private Lecturer Dr. Wolfgang Walther of the ECRC: "The MIDGE® vector of MOLOGEN AG is an excellent vector system available for this novel gene therapy. At the same time, the conclusion of the cooperation agreement is the starting signal for the preparatory work that will lead into a phase I/II clinical study. I look forward to the further collaboration."

Private Lecturer Dr. Uwe Trefzer, director of the Skin Cancer Center of the Charité: "If melanomas have developed metastases, there is currently no permanently successful therapy available. I am therefore eagerly and optimistically looking forward to this form of treatment.

Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, adds: "The finalized cooperation agreement is especially worthwhile for us, because our platform technology, the MIDGE® vector, will be clinically used here for the first time. That is why I am especially glad that the longtime collaboration with the Max Delbrück Centrum für Molekulare Medizin (Center for Molecular Medicine), one of the best German institutes in the field of molecular biology, has now also led to a cooperation agreement. We have already been able to show outstanding clinical data this year with our main products, MGN1703 and MGN1601. Now we also have the opportunity to clinically investigate another cancer immunotherapy".

MGN1404 – MIDGE® vector for TNF-alpha expression
Tumor necrosis factor alpha (abbreviated TNF-alpha) is a signaling substance (cytokine) of the immune system. Among other things, 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 MIDGE®-based (non-viral) expression vector. The needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE® vectors directly into the tumor cells. The expression of TNF-alpha is triggered by the MIDGE® vectors, and, lastly, cell death in the tumor cells is induced.

Malignant melanoma
Malignant melanomas are one of the most serious forms of skin cancer. The worldwide occurrence of malignant melanoma in the white population has increased continually and considerably in recent decades. Almost 14,000 people develop malignant melanoma in Germany each year, of whom approximately 8,000 are women and 6,000 are men. The lifetime risk of developing a melanoma is approximately 1:50 in Germany; in Australia, it is already 1:20. Middle-aged people between the ages of 45 and 60 are affected particularly often. Despite the lack of symptoms and a relatively small size, melanomas can metastasize in the lymph nodes and other organs at an early stage.

About the Max Delbrück Centrum für Molekulare Medizin (MDC), Berlin-Buch
The MDC was founded in 1992 to put the results of molecular research into practice for the prevention, diagnosis, and treatment of diseases. The location in the Buch district in northeast Berlin, with its clinics, research institutes, and biotechnology companies, offers an excellent environment for top-level, interdisciplinary, and patient-oriented research. As a result, the MDC has developed into an internationally recognized research institute in recent years. Thomson Reuters ranks the MDC 14th in its list of the 20 best institutes in the world in the field of molecular biology and genetics. The MDC is the only German institute on this list.

Approximately 1,535 employees and guest researchers are currently working at the MDC. The MDC is 90% financed by the federal government and 10% financed by the state of Berlin. External funding totaling millions rounds out the budget. 59 research groups are working in three areas of research focus (cardiovascular and metabolic diseases / cancer systems biology, diseases of the nervous system).

www.mdc-berlin.de

The Experimental and Clinical Research Center (ECRC)
As a joint establishment of the MDC and Charité, the Experimental and Clinical Research Center promotes collaboration between scientists conducting basic research and clinical researchers. Knowledge from the laboratory is utilized as directly as possible at the bedside, and new approaches for the diagnosis, prevention, and treatment of cardiovascular and metabolic diseases, cancer, and neurological diseases are developed and used on patients within a short time.

The ECRC offers an excellent environment for patient-oriented research, including clinical studies. This includes a growing number of university outpatient clinics that offer specialized advice for patients, a ward specifically designed for clinical research, a clean-room production facility for cellular immunotherapy, and access to the most modern procedures in ultra-high-field magnetic resonance imaging.

www.charite.de/forschung/forschungszentren/experimental_and_clinical_research_center_ecrc


Charité Comprehensive Cancer Center (CCCC)
The CCCC's goal is to unify clinical and academic oncology at the Charité, thereby coordinating diagnosis, therapy, medical and psychological issues and follow-up care for patients, as well as to find new approaches to prevention and early diagnosis of disease.

Effective treatment requires a close collaborative effort by specialists from several different areas of expertise starting from the earliest stages of the disease. In recognition of this, and in order to further improve patient care, the Charité founded a Comprehensive Care Center in 2008, establishing one of the first centers in Germany to provide a comprehensive approach to the treatment of tumors.

Through a collaboration of private doctors and hospitals, we aim to improve the care of patients suffering from tumors and their chances for cures.

The CCCC networks all Charité sites involved in tumor therapies and related disciplines in order to ensure holistic, interdisciplinary care of tumor patients. Through the CCCC, each patient should receive access to the most current national and international strategies for care and clinical studies.

The Charité Comprehensive Cancer Center (CCCC) is a Center of Excellence in Oncology, supported by the Deutsche Krebshilfe (German Cancer Aid). It is a member of the Organization of European Cancer Institutes and is certified by the Deutsche Krebsgesellschaft (German Cancer Society).


About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin specializes in the research and development of innovative medications on the basis of DNA structures. The activities focus on numerous product developments which are relevant to the immune system; on the one hand vaccines against infectious diseases and on the other hand cancer medications. MOLOGEN AG is globally one of the few biotechnology companies with well tolerated DNA-based cancer treatment in the clinical development phase.

The stocks of MOLOGEN AG are listed in the Prime Standard of the German stock exchange (ISIN DE0006637200).

www.mologen.com


Memberships in associations:
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® and MOLOGEN® are registered trademarks of MOLOGEN AG.

 

Note about risk for future predictions
Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.

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