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Recombinant human p53 adenovirus for injection, Gendicine® is a genetic engineering-modified, infectious recombinant human p53 adenovirus particle (rAd-p53). It is consisted of defective human adenovirus-5 and normal p53 tumor suppressor gene. The virus particle acts as a vector to carry the p53 gene into a tumor cell, where the p53 plasmid expresses as P53 protein, causing tumor cell growth suppression and induction of apoptosis. Anti-angiogenesis and by-stander tumor cell killing are also affected. Gendicine® was approved to be marketable in 2004 by SFDA as the first gene therapy drug in the world market. To summarize the clinical results, the advantages of Gendicine® in the treatment of cancer are: 1) the biological mechanism is very clear, 2) multiple effect against cancer, 3) wide spectrum anti-tumor type, 4) high safety margin would allow better quality of life for patients, 5) high synergistic effect with other treatment modalities. The basic and clinical sciences studies have confirmed the synergistic effect of Gendicine® in chemo-, radio-, thermotherapy. Pre-surgical use of the drug can shrink the tumor size, structure and area of involvement, and tumor-normal tissue junction injection peri-operatively.
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