Berlin, Germany, December 14, 2010 / b3c newswire / - The Charité - Medical
MOLOGEN AG, which has since the outset been building its research activities on a diversified product pipeline, has also achieved a decisive milestone in an additional product segment with the start of the clinical study for the renal cancer medication MGN1601.
The primary goal of this study is the investigation of the safety and tolerability of the medication. In addition effectiveness data is recorded, which contain the clinical, immunological and radiological parameters of the patients.
As a leading research company in DNA medicine and cell-based medicine, MOLOGEN AG is consistently pursuing its goal of developing highly effective and safe medications for the treatment of cancer illnesses.
The procedures developed by MOLOGEN AG for cell-based gene therapy against renal cancer involve a therapeutic vaccination to combat advanced tumors of the kidneys and the prevention of their reappearance after operations and medical treatment.
The basis of the therapy is human renal cancer cells. MOLOGEN itself has established a unique renal cancer cell line for this purpose. These cancer cells which are foreign (allogenic) for the patient are "gene-modified" with the help of MIDGE® DNA vectors with additional genetic information and combined with MOLOGEN's own DNA immune modulator dSLIM® as effectiveness enhancer (adjuvant).
The active principle of the cell-based gene therapy consists of provoking a cross-reaction of the immune system of the patients against their own cancer cells after the immune system has learned by the reaction against the gene-modified, foreign cancer cells how cancer cells typically appear. In preclinical investigations, the preparation has already exhibited outstanding tolerability and effectiveness.
Dr. Marina Tschaika, director of the clinical development department at MOLOGEN AG, explains: "With MGN1601 we hope to have developed a cancer therapy with few side effects, which will lead to long-term relief of cancer suffering and, at the same time, to a clear improvement in the quality of life for patients with advanced renal cancer. I am convinced that we are on the right track with this".
Study director PD Dr. Steffen Weikert, Charité Berlin
The clinical study is being directed by Dr. Steffen Weikert, assistant director of the clinic for Urology at the Charité of Berlin.
PD Dr. Steffen Weikert, an expert in the area of renal cancers, comments about the start of the study: "The ASET study with the preparation MGN1601 is an extremely interesting and promising study for us, because it builds on an advanced concept of therapeutic vaccination against renal cancer cells. We hope to continue to improve the prognosis for patients with advanced renal cancer with this therapeutic approach. This study will also open up to our patient perspectives for a better quality of life since the vaccination can be considered as low in side effects according to the current state of the art. We are pleased that the first patients can now be accepted for the study at Charite“.
With the Charité as a test centre, this clinical study can fall back on a wealth of expertise. This is because the Charité Comprehensive Cancer Center comprehensively organizes and coordinates holistic collaboration in the area of tumor medicine among the various Charité centers. Thanks to the close cooperation and involvement of the entire medical, psycho-oncological and social care chain as well as innovative research projects and clinical studies, a comprehensive and modern therapy for tumor patients is sustainably supported. The
As additional test centers MHH -
Study hotline / study portals
The study is listed on all relevant Internet portals.
A study hotline of MOLOGEN AG on MGN1601 informs interested medical specialists and patients individually at: +49 (0)800 1601 646.
About renal cancer
Renal cancer is the most frequently occurring malignant tumor of the kidneys with 200,000 incidences annually throughout the world. According to the Robert Koch Institute, there are 15,000 patients affected with this illness in
Orphan Drug Status
The cell-based gene therapy against renal cancer has received the Orphan Drug Status from the European Medical Agency (EMA). This allows MOLOGEN AG to have a 10-year marketing exclusivity of the product within the European Union. The Orphan Drug Program of the European Union should promote the development of therapies for rare and serious illnesses.
About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in
MOLOGEN AG shares are listed on the Prime Standard of the German Stock Exchange
(ISIN DE 0006637200).
Memberships and 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
MIDGE®, dSLIM® and MOLOGEN® are registered trademarks of MOLOGEN AG.
Prof. Peter W. Hübner
Head of Corporate Communications
D - 14195 Berlin
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
Tel: +49 - 30 - 84 17 88 - 13
External Investor Relations
Kirchhoff Consult AG
Janina Wismar M.A.
Tel: +49 - 40 - 60 91 86 - 50
Fax: +49 - 40 - 60 91 86 - 16
Disclaimer with regard to statements regarding future events
Certain information in this release contains forward-looking statements or relevant statements that are negated or versions that deviate from this or comparable terminology - these are called "forward-looking statements." In addition, all information presented here that refers to planned or future developments in business areas, key figures, financial results or other financial numbers or statistical statements contains such forward-looking statements. The company advises discerning investors not to rely on these forward-looking statements as predictions regarding the future occurrence or development of real future events. The company does not commit to updating the forward-looking statements and refuses any liability in this regard. The forward-looking statements only reflect the status on the day the statement is released.
[ Note: need to ensure Disclaimer covers