Method for detecting replication or colonization of a biological therapeutic
First Claim
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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.
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Abstract
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.
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Citations
20 Claims
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1. A method for treating cancer and monitoring therapeutic progress in a subject having tumors, said method comprising:
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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; andd) 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification