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MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma initiated

- Phase I trial to evaluate safety and tolerability

- Trial is under supervision of Charit - Universitaetsmedizin Berlin

Berlin, October 18, 2013 - The phase I clinical trial with the cancer immune therapy MGN1404 has been started. The trial evaluates the safety and tolerability of MGN1404 for the treatment of malignant melanoma. Furthermore data on the mechanism of action will be collected. MGN1404 will be applied in different dosages needle-free by jet-injection into skin metastases. It is planned to overall enroll nine patients in the trial. The study is a translational project for non-viral gene therapy and will be conducted by Charit in collaboration with Charit Comprehensive Cancer Center (CCCC), Experimental and Clinical Research Center (ECRC), Max Delbrueck Center for Molecular Medicine Berlin-Buch (MDC) as well as Skin Cancer Center Charit (SCCC). Principial investigator is Dr. med. Felix Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center Charit and scientific coordinator is Prof. Wolfgang Walther, ECRC, Charit.

Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, 'With this study the third drug candidate from our broad pipeline of cancer immune therapies is entering the clinical development phase. I am especially glad that the longtime collaboration with the Max Delbrueck Center for Molecular Medicine, one of the best German institutes in the field of molecular biology, has now led to this trial. MGN1404 is addressing a severe disease with high unmet medical need. We are looking forward to the outcome of the trial.'

http://www.mologen.com

Additional information:

MGN1404 - MIDGE(R) vector for TNF-alpha expression Tumor necrosis factor alpha (abbreviated TNF-alpha) is a signaling substance (cytokine) of the immune system. 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 minimalistic, non-viral DNA expression vector encoding for TNF-alpha, based on MOLOGEN'S proprietary MIDGE(R) platform technology. The needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE(R) vectors directly into the tumor cells. The expression of TNF-alpha is triggered there by the MIDGE(R) vectors aiming to induce cell death in the tumor.

Malignant melanoma Malignant melanomas are one of the most malignant forms of skin cancer. The worldwide occurrence of malignant melanoma in the white population has increased continually and considerably in recent decades. Approximately 77,000 people in the USA and 100,000 people in Europe develop malignant melanoma each year. Despite the lack of symptoms and a relatively small size, melanomas can metastasize early in the lymph nodes and other organs. If diagnosed when there are already distant metastases the five-year survival rate is approximately 10-20%. Treatments of late stage malignant melanoma include chemotherapy, immunotherapy or radiation therapy.

Read more from the original source:
DGAP-News: MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma initiated

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