Challenge
A sponsor organization developed a novel oncolytic viral therapeutic of genetically engineered herpes simplex virus type 1 (HSV-1) targeted to treat glioblastoma. Battelle was contracted to complete a good laboratory practice (GLP), investigational new drug (IND)-enabling study, evaluating the toxicity, biodistribution and efficacy of the therapeutic in a human orthotopic xenograft model.
The Solution
Battelle developed and validated a quantitative polymerase chain reaction (qPCR) assay in mouse blood and tissue matrices using a plasmid construct containing the target as positive control. The validated assay detected as few as five target copies per microgram of DNA with 95% confidence and met other strict criteria for specificity, accuracy and precision.
The test article was administered directly to the brain of immunocompromised preclinical models.
The test article was administered directly to the brain of immunocompromised preclinical models.
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The Outcome
Battelle demonstrated low/no biodistribution of the oncolytic virus outside the target brain tissue.
The FDA approved the IND application and allowed progression of the oncolytic viral therapeutic into phase I clinical trials.
The FDA approved the IND application and allowed progression of the oncolytic viral therapeutic into phase I clinical trials.
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