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MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma initiated

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma
initiated

18.10.2013 / 08:00

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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 Charité - 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 Charité in collaboration with Charité 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 Charité (SCCC). Principial investigator is Dr. med. Felix
Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center
Charité and scientific coordinator is Prof. Wolfgang Walther, ECRC,
Charité.

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.'

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)