Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses
Oncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations. Since these early reports, studies using OV have progressed from anecdotal and controlled infections to specifically selecting or genetically modifying viruses for cancer treatment. OV are intended to replicate selectively in tumour tissue and spread, destroying the tissue without causing excessive damage to normal tissues.
OV can be wild type or naturally attenuated strains of viruses that possess an inherent property of selective replication and lysis of cancer cells. Additionally, viruses can be genetically modified to selectively replicate and lyse cancer cells. These modifications can include 1) the mutation of the viral coding genes that are critical for viral replication in normal cells, 2) the control of early gene expression by using tumour-specific promoters, 3) a change in the viral tissue tropism and/or cell entry process, and 4) the incorporation of transgenes into the viral genome. Examples of OV include adenovirus, measles virus, vesicular stomatitis virus (VSV), reovirus, Newcastle disease virus, herpes simplex (HSV), poxvirus, Sendai virus, and others.
Regulatory authorities represented at the ICH agree that the therapeutic potential of OV will need to be balanced against the risks associated with the use of virus that is replication competent. This document identifies general principles for the clinical development of OV.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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