OS Therapies announces that the last patient enrolled in the AOST-2121 clinical trial NCT04974008 of OST-HER2 in recurred, resected Osteosarcoma OS has completed their final radiographical evaluation at 52 weeks and the treatment period for the clinical trial has now ended. The Company is preparing to request a Type C Meeting with the U.S. Food & Drug Administration FDA and to make any protocol adjustments based on FDA’s recommendations. Following those adjustments, the Company will lock the clinical trial database in preparation for data analysis and topline data readout, expected to be announced in the fourth quarter of 2024…The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T-cells that can eliminate or slow potential micro-metastases that can grow into recurrent Osteosarcoma. T-cell responses target HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent Osteosarcoma in the United States. There have not been any novel therapeutic interventions approved by the FDA in over 40 years.
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