Abstract
Many types of oncolytic viruses, wild-type virus, attenuated viruses and genetically-modified viruses, have been developed as an innovative cancer therapy. The strategies, nature, and technologies of oncolytic virus products are different from the conventional gene therapy products or cancer therapy products. From the regulatory aspects to ensure the safety, efficacy and quality of oncolytic viruses, there are several major points during the development, manufacturing, characterization, non-clinical study and clinical study of oncolytic viruses. The major issues include 1) virus design (wild-type, attenuated, and genetically engineered strains), 2) poof of concept in development of oncolytic virus products, 3) selectivity of oncolytic virus replication and targeting to cancer cells, 4) relevant animal models in non-clinical studies, 5) clinical safety, 6) evaluation of virus shedding. Until now, the accumulation of the information about oncolytic viruses is not enough, it may require the unique approach to ensure the safety and the development of new technology to characterize oncolytic viruses.
Keywords: Gene therapy, cancer therapy, replicating virus
Current Cancer Drug Targets
Title: Regulatory Aspects of Oncolytic Virus Products
Volume: 7 Issue: 2
Author(s): Teruhide Yamaguchi and Eriko Uchida
Affiliation:
Keywords: Gene therapy, cancer therapy, replicating virus
Abstract: Many types of oncolytic viruses, wild-type virus, attenuated viruses and genetically-modified viruses, have been developed as an innovative cancer therapy. The strategies, nature, and technologies of oncolytic virus products are different from the conventional gene therapy products or cancer therapy products. From the regulatory aspects to ensure the safety, efficacy and quality of oncolytic viruses, there are several major points during the development, manufacturing, characterization, non-clinical study and clinical study of oncolytic viruses. The major issues include 1) virus design (wild-type, attenuated, and genetically engineered strains), 2) poof of concept in development of oncolytic virus products, 3) selectivity of oncolytic virus replication and targeting to cancer cells, 4) relevant animal models in non-clinical studies, 5) clinical safety, 6) evaluation of virus shedding. Until now, the accumulation of the information about oncolytic viruses is not enough, it may require the unique approach to ensure the safety and the development of new technology to characterize oncolytic viruses.
Export Options
About this article
Cite this article as:
Yamaguchi Teruhide and Uchida Eriko, Regulatory Aspects of Oncolytic Virus Products, Current Cancer Drug Targets 2007; 7 (2) . https://dx.doi.org/10.2174/156800907780058790
DOI https://dx.doi.org/10.2174/156800907780058790 |
Print ISSN 1568-0096 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-5576 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Functional Imaging Techniques for the Evaluation of Hepatocellular Carcinoma Using Dynamic 11C-Acetate PET Imaging
Current Medical Imaging Hepatocarcinogenesis and Ceramide/Cholesterol Metabolism
Anti-Cancer Agents in Medicinal Chemistry Anticancer and Cytotoxic Activities of [Cu(C6H16N2O2)2][Ni(CN)4] and [Cu(C6H16N2O2)Pd(CN)4] Cyanidometallate Compounds on HT29, HeLa, C6 and Vero Cell Lines
Anti-Cancer Agents in Medicinal Chemistry Defensins: Key Molecules in Ocular Surface Protection
Current Immunology Reviews (Discontinued) Players in ADP-ribosylation: Readers and Erasers
Current Protein & Peptide Science New Strategies in the Discovery of Novel Non-Camptothecin Topoisomerase I Inhibitors
Current Medicinal Chemistry Effect of Doxycycline on Atherosclerosis: From Bench to Bedside
Recent Patents on Cardiovascular Drug Discovery Fluorine-18 Labeled Amino Acids for Oncologic Imaging with Positron Emission Tomography
Current Topics in Medicinal Chemistry Deciphering the Systems Biology of mTOR Inhibition by Integrative Transcriptome Analysis
Current Pharmaceutical Design Complexity in Clinical Trials: Blind Spots, Misleading Criteria, Winners and Losers
Clinical Cancer Drugs Identification of Drug Candidates for Breast Cancer Therapy Through Scaffold Repurposing: A Brief Review
Current Drug Research Reviews Chemopreventive Properties of Tolfenamic Acid: A Mechanistic Review
Current Medicinal Chemistry Vasoactive Intestinal Peptide Receptors: A Molecular Target in Breast and Lung Cancer
Current Pharmaceutical Design Drug Delivery Strategies Based on Nanotechnology for Cancer Immunotherapy
Current Organic Chemistry The Smart Targeting of Nanoparticles
Current Pharmaceutical Design CARING (CAncer Risk and INsulin analoGues): The Association of Diabetes Mellitus and Cancer Risk with Focus on Possible Determinants - A Systematic Review and a Meta-Analysis
Current Drug Safety Regulation of Arylamine N-Acetyltransferases
Current Drug Metabolism UCLA’s Molecular Screening Shared Resource: Enhancing Small Molecule Discovery with Functional Genomics and New Technology
Combinatorial Chemistry & High Throughput Screening A Point of View: The Need to Identify an Antigen in Psyconeuroimmunological Disorders
Current Pharmaceutical Design Cisplatin Properties in a Nanobiotechnological Approach to Cancer: A Mini-Review
Current Cancer Drug Targets