Translation of genetic knowledge from the Human Genome into disease-specific therapy for untreatable congenital and acquired diseases is now reality. However, the gene therapy vectors currently used in experimental settings can be developed for safe clinical application only if fundamental problems are solved: ie the limitation of vector dose by attachment targeting and expression control and a decrease of non-specific toxicity. Minimisation of vector immunogenicity (stealthing) is necessary to reduce bloodstream and immune-mediated reduction of effective vector concentration. In the GIANT project, targeting and stealthing of both viral and non-viral vectors will be used to select candidates for testing in Phase I clinical studies. GIANT will concentrate firstly on one uniform model system and disease target (prostate carcinoma) for vector testing standardisation and in vitro, preclinical and clinical vector comparison. We will use a clinically approved vector backbone of adenoviral constructs re-targeted to prostate cancer via surface antigens, and hybrid prostate targeted promoters. The consortium includes a GMP vector production facility and clinical facilities with scientific and ethical permission to carry out human cytotoxic gene therapy trials, guaranteeing the immmediate translation of selected vectors into the clinical testing. The biomaterials obtained will serve to develop new assays for vector distribution, efficacy and monitoring of the immune response against various vector systems. The GIANT participants have a long record of EU-based scientific collaboration and expertise in ethically approved clinical vector generation. The SMEs own international patents on retargeting vectors and target discovery methods, providing a technology platform for further exploration of promising targets and innovative approaches to facilitate treatment of...
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