MedPacto Initiates Clinical Trial of Bactosertib for Osteosarcoma... First Patient Dosed

MedPacto announced on the 3rd that it has completed the first patient dosing in the Phase 1/2 clinical trial of Batocertinib monotherapy for osteosarcoma being conducted in South Korea and the United States. With the completion of dosing, the Phase 1/2 clinical trial of Batocertinib monotherapy for osteosarcoma has officially commenced.

[Photo by MedPacto]

MedPacto received approval for the Investigational New Drug (IND) application for Batocertinib monotherapy targeting osteosarcoma patients from the U.S. Food and Drug Administration (FDA) in August last year. In February, it also obtained IND approval from the Korea Ministry of Food and Drug Safety.

The clinical trial is being conducted in the U.S. and South Korea on 54 adolescent and adult patients aged 14 and older with recurrent, refractory, or progressive osteosarcoma. MedPacto plans to evaluate the safety, tolerability, pharmacokinetics, and anticancer efficacy of Batocertinib monotherapy in the trial.

Osteosarcoma cannot be completely removed with a single surgery, so continuous chemotherapy is required to eliminate all cancer in the bones. It is common for the cancer to metastasize to the lungs and brain even during chemotherapy, and the 5-year survival rate for metastatic patients is only about 20-30%. Since metastasis to the lungs and brain often leads to death, blocking metastasis alone can improve survival rates.

A MedPacto representative stated, "With successful clinical progress, Batocertinib monotherapy is expected to establish itself as a treatment option for osteosarcoma patients who currently have no adequate therapies."

Meanwhile, Batocertinib monotherapy for osteosarcoma patients has also been designated by the FDA as a Rare Pediatric Disease Drug (RPDD) and a Fast Track development candidate.

This content was produced with the assistance of AI translation services.