MOLOGEN AG: Skin cancer study with MGN1404 approved

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Evaluation of safety and tolerability
Further product candidate ready for phase I clinical study
Study under the direction of the Charité Universitätsmedizin

The Paul-Ehrlich Institute has granted approval for a phase I clinical study of a gene therapy with MGN1404 for the treatment of melanomas (Press release Mologen, APR 15, 2013, View Source [SID:1234501173]). The study is entitled "Phase I trial of TNF-alpha expressing MIDGE-vector non-viral gene transfer in skin metastases of melanoma." The study will be conducted by collaborative partners Charité Comprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical Research Center of the Charité (ECRC), the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the Charité (Hauttumorcentrum, HTCC).

The study will examine whether the MIDGE vector is safe and well tolerated when applied by intra-tumor jet injector, and whether the application leads to efficient expression of the hTNF-alpha gene. Further, the magnitude and extent of gene expression and the distribution of the MIDGE vector within and outside the injected tumor will be examined. Three different doses of the MIDGE vector will be used. This study is a first step towards the clinical use of local gene therapy for malignant melanomas.