Human papillomaviruses (HPV) may cause pre-cancer or cancer in humans, particularly in the genital region or at the anus. More than one million of patients worldwide develop pre-cancer caused by HPV every year. Generally, those lesions are treated with surgery or laser therapy, which may cause considerable side effects in the affected patients. A targeted therapy that may spare normal tissue from damage is currently missing.
We have identified a molecular mechanism by which HPV alters the cells to become malignant and identified a class of drugs that may revert this situation. We are developing a novel treatment strategy with those substances that may be applied to the pre-cancer locally by the patients themselves. Thereby, we intend providing a causally effective therapy against HPV pre-cancer that, at the same time, may reduce treatment side effects in patients.
The aim of ViMREX
The aim of the ViMREX project is to develop a marketable local therapy against HPV-induced precancerous lesions in the anogenital tract using demethylating agents. The study comprises the:
a) conduction of comprehensive laboratory analyses, e.g.:
establishment of a local formulation prototype
determination of treatment effects such as cell death and cellular senescence and transcriptome analyses
development of innovative 3D cultures of HPV-transformed cells such as organotypic co-cultures from HPV-transformed cell lines and normal keratinocytes, long-term cultivation of patient-derived biopsies on dermal equivalents and tumor spheroids to provide a quasi-realistic model for treatment in the preclinical setting
optimization of treatment schedule (concentration, frequency, duration etc.)
b) planning and conduction of regulatorily required preclinical analyses, e.g.:
extensive stability analyses
preclinical toxicity testing on animals
c) planning and conduction of a clinical phase I study followed by a clinical phase IIa study on patients with precancerous HPV-induced vulvar intraepithelial neoplasia.
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