Successful Type C Meeting with US FDA Regarding Ph 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Announced
“We were very pleased that we made meaningful progress with the FDA on the potential of using immune activation biomarker data as a surrogate endpoint of clinical efficacy and on the proposed design of a confirmatory study design required to be initiated prior to received Accelerated Approval,” said Paul Romness, Chairman & CEO of OS Therapies. “Dr. Anderson’s meaningful contribution helped shape the conversation about the significant unmet medical need and inform the agency about the critical value of Comparative Oncology in potentially helping speed therapies to market in osteosarcoma. We expect not only to have biomarker data from our human clinical study to share with FDA, but also to have additional biomarker data from our canine program in frontline osteosarcoma which is the disease setting that FDA suggested may be suitable to conduct a confirmatory randomized study as part of an agreement with the agency regarding Accelerated Approval.”
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