An important new collection of clinical and preclinical reports on genetic therapy, this book describes illustrative examples of diseases in which gene-based interventions are presently plausible, and presents case studies of current research using both synthetic oligonucleotides and biological vectors. Combining the insights of over 50 contributors, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors 7furnishes a historical overview of genetic therapy 7highlights official Food and Drug Administration positions on the preparation of oligonucleotides and vectors 7offers…mehr
An important new collection of clinical and preclinical reports on genetic therapy, this book describes illustrative examples of diseases in which gene-based interventions are presently plausible, and presents case studies of current research using both synthetic oligonucleotides and biological vectors. Combining the insights of over 50 contributors, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors 7furnishes a historical overview of genetic therapy 7highlights official Food and Drug Administration positions on the preparation of oligonucleotides and vectors 7offers practical models of agent preparation, animal testing, pharmacokinetics, toxicology, and clinical trials 7discusses both synthetic DNA and biological vector approaches to cancer, viral, and cardiological indications 7illustrates for new practitioners how each stage of genetic therapy is developed 7details genetic treatment of leukemia; lymphoma; cancer of the brain, breast, colon, kidney, and lung; melanoma; HIV; and coronary restenosis 7includes examples of antisense, ribozyme, tumor suppressor, immunostimulation, and gene replacement therapy 7and addresses questions of preparation, delivery, toxicity, mechanism, and specificity.
A Brief History of Genetic Therapy: Gene Therapy Antisense Technology and Genomics James W. Hawkins Preclinical Development of Oligonucleotide Therapeutics for Cancer: Regulatory Aspects Chang-Ho Ahn and Joseph J. DeGeorge Commercial Scale Manufacturing of Oligonucleotides Under Good Manufacturing Practices Jose E. Gonzalez Richard G. Einig Patricia Puma Timothy P.Noonan Paul E. Kennedy Bruce G. Sturgeon Bing H. Wang and Jin-yan Tang The Regulatory Process and Gene Therapy Suzanne L. Epstein Production of Clinical Lots of Gene Therapy Vectors Using Good Manufacturing Practice: Experience in a University Setting Alan R. Davis and Colleen Baker Gene Therapy Clinical Trials for Adenosine Deaminase Deficiency/Severe Combined Immunodeficiency Erlinda M. Gordon and W. French Anderson Development of an Oligodeoxynucleotide Pharmaceutical for the Treatment of Human Leukemia Alan M. Gewirtz and Deborah Lee Sokol Clinical Trials with Anti-p53 DNA OL(1)p53 in Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome Patrick L. Iversen Human Bcl-2 Antisense Therapy for Lymphomas Finbarr E. Cotter Andrew Webb Paul Clarke and David Cunningham Retroviral Gene Transfer in Autologous Bone Marrow and Stem Cell Transplantation Rafat Abonour and Kenneth Cornetta Adenoviral Gene Transfer of the Herpes Virus Thymidine Kinase Gene for Treating Gliomas Jane B. Alavi Jason G. Smith and Stephen L. Eck Distribution and Toxicity of Retroviral Vectors After Intracavitary Delivery in Mouse and Man Patrice S. Obermiller Anne M. Pilaro Carlos L. Arteaga and Jeffrey T. Holt Clinical and Immunologic Responses to Gene Transfer of an Allogeneic Major Histocompatibility Complex Antigen Alison T. Stopeck and Evan M. Hersh Defective Tumor Suppressor Gene Replacement and Oncogene Inactivation for the Treatment of Cancer Jack Roth The Molecular Basis of Bladder Cancer and Prospects for Gene Therapy Using Hammerhead Ribozymes Eric J. Small Mohammed Kashani-Sabet David Y. Bouffard and Kevin J. Scanlon In Situ Gene Insertion for Immunotherapy Using Vaccinia Virus Vectors Edmund C. Lattime Laurence C. Eisenlohr and Michael J. Mastrangelo Antisense Oligonucleotide-Based Therapy for HIV-1 Infection from Laboratory to Clinical Trials Sudhir Agrawal Treatment of Retinitis Induced by Cytomegalovirus Using Intravitreal Fomivirsen (Isis 2922) Stanley T. Crooke Synthetic DNA-Based Compounds for the Prevention of Coronary Restenosis: Current Status and Future Challenges Andrew Zalewski Yi Shi John D. Mannion and Fernando Roqué Prevention of Restenosis by Gene Targeting Michael J. Mann Heiko E. Von der Leyen and Victor J. Dzau
A Brief History of Genetic Therapy: Gene Therapy Antisense Technology and Genomics James W. Hawkins Preclinical Development of Oligonucleotide Therapeutics for Cancer: Regulatory Aspects Chang-Ho Ahn and Joseph J. DeGeorge Commercial Scale Manufacturing of Oligonucleotides Under Good Manufacturing Practices Jose E. Gonzalez Richard G. Einig Patricia Puma Timothy P.Noonan Paul E. Kennedy Bruce G. Sturgeon Bing H. Wang and Jin-yan Tang The Regulatory Process and Gene Therapy Suzanne L. Epstein Production of Clinical Lots of Gene Therapy Vectors Using Good Manufacturing Practice: Experience in a University Setting Alan R. Davis and Colleen Baker Gene Therapy Clinical Trials for Adenosine Deaminase Deficiency/Severe Combined Immunodeficiency Erlinda M. Gordon and W. French Anderson Development of an Oligodeoxynucleotide Pharmaceutical for the Treatment of Human Leukemia Alan M. Gewirtz and Deborah Lee Sokol Clinical Trials with Anti-p53 DNA OL(1)p53 in Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome Patrick L. Iversen Human Bcl-2 Antisense Therapy for Lymphomas Finbarr E. Cotter Andrew Webb Paul Clarke and David Cunningham Retroviral Gene Transfer in Autologous Bone Marrow and Stem Cell Transplantation Rafat Abonour and Kenneth Cornetta Adenoviral Gene Transfer of the Herpes Virus Thymidine Kinase Gene for Treating Gliomas Jane B. Alavi Jason G. Smith and Stephen L. Eck Distribution and Toxicity of Retroviral Vectors After Intracavitary Delivery in Mouse and Man Patrice S. Obermiller Anne M. Pilaro Carlos L. Arteaga and Jeffrey T. Holt Clinical and Immunologic Responses to Gene Transfer of an Allogeneic Major Histocompatibility Complex Antigen Alison T. Stopeck and Evan M. Hersh Defective Tumor Suppressor Gene Replacement and Oncogene Inactivation for the Treatment of Cancer Jack Roth The Molecular Basis of Bladder Cancer and Prospects for Gene Therapy Using Hammerhead Ribozymes Eric J. Small Mohammed Kashani-Sabet David Y. Bouffard and Kevin J. Scanlon In Situ Gene Insertion for Immunotherapy Using Vaccinia Virus Vectors Edmund C. Lattime Laurence C. Eisenlohr and Michael J. Mastrangelo Antisense Oligonucleotide-Based Therapy for HIV-1 Infection from Laboratory to Clinical Trials Sudhir Agrawal Treatment of Retinitis Induced by Cytomegalovirus Using Intravitreal Fomivirsen (Isis 2922) Stanley T. Crooke Synthetic DNA-Based Compounds for the Prevention of Coronary Restenosis: Current Status and Future Challenges Andrew Zalewski Yi Shi John D. Mannion and Fernando Roqué Prevention of Restenosis by Gene Targeting Michael J. Mann Heiko E. Von der Leyen and Victor J. Dzau
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