Method for detecting replication or colonization of a biological therapeutic

摘要

Methods for detecting replication in or colonization of a host by a biological therapeutic, such as an oncolytic virus, cells administered for cell therapy and gene therapy vectors, are provided. In the methods, a product produced by the biological therapeutic is detected in a sample of tissue or body fluid distinct from the administered therapy or locus thereof, thereby permitting assessment of the therapy and/or monitoring its progress.

主权项

1. A method for treating cancer and monitoring therapeutic progress in a subject having tumors, said method comprising:
a) administering to said subject an oncolytic virus encoding a β-glucuronidase, wherein said oncolytic virus targets and treats cancer and the β-glucuronidase activity indicates oncolytic viral colonization or replication in said cancer; b) obtaining a sample from a subject, wherein said sample is a body fluid or tissue sample that is not a tumor sample; c) detecting β-glucuronidase activity in the sample, wherein said detection is by the addition of a substrate for β-glucuronidase; and d) determining the presence of a product catalyzed by the reaction of the β-glucuronidase with the substrate, wherein the detection of the product indicates that the oncolytic virus has colonized or is replicating in a tumor tissue or cell in the subject and is treating said tumor tissue or cell and oncolytic viral therapy be continued.