Case Study

Oncolytic Viral Therapeutic

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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. 
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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.
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