Abstract
Safety data were collected from 445 patients treated with Advexin® (adenoviral p53) gene therapy for cancer in 14 clinical trials (Phase I, II and III). Advexin gene therapy was used as monotherapy in 11 trials and in combination with chemotherapy or radiation in 3 clinical studies. The treated patients had advanced cancers, primarily lung and squamous cell head and neck cancers, but also included patients with prostate cancer, colorectal cancer, and other solid tumors. Most patients were treated with multiple cycles of therapy by an intratumoral route of administration, while 17 patients were treated intravenously. Overall, greater than 3,000 injections of Advexin were administered.
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