Positive Biomarker Data from Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Announced
“Leveraging the power of Comparative Oncology, we were able to train and test potentially predictive biomarkers from the Canine Metastatic Osteosarcoma Trial in order to form a hypothesis to test in a pre-specified way in the Human Metastatic Osteosarcoma Trial,” said Paul Romness, MHP, Chairman & CEO of OS Therapies. “We believe the confirmation of this pre-specified pathway analysis in humans adds significant resolution to our clinical data, increasing the clinical interpretability of the 2-year overall survival data for regulatory agencies. The confirmation of a pre-specified canine biomarker pathway being upregulated in a comparable human clinical study population leveraged canine biomarker data to a generate hypothesis that was tested in a pre-specified way and confirmed as a surrogate marker of clinical efficacy. This biomarker data strengthens our pending Biologics License Application (BLA) submission.”
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