Cancer Gene Therapy by Viral and Non-viral Vectors -- Copyright -- Contents -- List of Contributors -- Series Foreword -- Preface -- Part I Delivery Systems -- 1 Translational Cancer Research: Gene Therapy by Viral and Non-viral Vectors, -- Adenovirus -- Oncolytic Adenoviruses for Treatment of Cancer -- Vaccinia Virus -- Herpes Virus -- Parvovirus -- Final Remarks -- References -- 2 Retroviruses for Cancer Therapy -- Introduction -- Overview of Retroviral Vectors -- Gammaretroviral and Alpharetroviral Vectors -- Foamyviral (Spumaviral) Vectors -- HIV-1-Derived Lentiviral Vectors -- Evolution of HIV-1-Derived Lentiviral Vectors -- Retroviral Vector-Mediated RNAi Therapy: From Basic Science to Clinical Trial -- Concluding Remarks and Challenges -- Acknowledgments -- References -- 3 DNA Plasmids for Non-viral Gene Therapy of Cancer -- Delivery -- Expression of Transgenes from DNA Plasmid -- Safety -- Therapeutic Applications -- Summary -- References -- 4 Cancer Therapy with RNAi Delivered by Non-viral Membrane/Core Nanoparticles -- Introduction -- Barriers -- Overcoming Delivery Barriers -- Putting it All Together: Model Examples of Innovative and Successful NPs -- Conclusions -- Acknowledgments -- References -- Part II Targeted Expression -- 5 Cancer Gene Therapy by Tissue-specific and Cancer-targeting Promoters -- Introduction -- Cancer-Specific Promoters -- Cancer-Targeting Promoters -- Engineered Systems that Enhance Promoter Activity -- Conclusion -- References -- 6 MicroRNAs as Drugs and Drug Targets in Cancer -- Introduction -- MiRNA and its Functioning Mechanism -- MiRNA and Cancers -- MiRNA in Other Diseases -- MiRNA Therapeutics -- Challenges -- Outlook -- References -- Part III Principles of Clinical Trials in Gene Therapy -- 7 Regulatory Issues for Manufacturers of Viral Vectors and Vector-transduced Cells for Phase I/ II Trials.

Introduction -- Development of Good Manufacturing Practices -- cGMP Requirements -- cGMP Compliance -- Practical Compliance: One Center's Experience -- Conclusions -- Acknowledgments -- References -- 8 US Regulations Governing Clinical Trials in Gene Therapy -- Introduction -- NIH OBA and RAC -- IBC -- IRB -- FDA -- Protocol -- Consent Form -- Multisite Protocols -- Conclusion -- References -- 9 Remaining Obstacles to the Success of Cancer Gene Therapy -- Introduction -- Drug-Development Pathways -- Broadening the Appeal of Complex Biologics -- Clinical Trial Design and Execution -- Conceptual Limitations -- Conclusions -- References -- Index.