MedPacto is set to launch a Phase 2 investigator-initiated clinical trial evaluating vactosertib, their TGF-β inhibitor anti-cancer drug, in pediatric osteosarcoma patients. The study will be conducted in collaboration with prestigious U.S. medical institutions, including Stanford University and Case Western Reserve University Hospitals.
Understanding the Unmet Need
Osteosarcoma, a malignant tumor originating in bones or cartilage, represents one of the most prevalent pediatric cancers, particularly affecting children and adolescents. The disease carries a severe prognosis, with approximately 50% of patients developing fatal lung metastasis. Current immunotherapy approaches have shown limited effectiveness, highlighting the critical need for innovative treatment strategies.
Clinical Trial Design and Development
The announcement was made during the Pediatric Oncology Experimental Therapeutics Investigators Consortium (POETIC) Winter Meeting in Los Angeles. Dr. Kristen Vanheyst from Case Western Reserve University's UH Rainbow Babies and Children's Hospital and Dr. Allison Pribnow from Stanford University's Children's Hospital presented the therapeutic potential of vactosertib.
The upcoming Phase 2 trial will focus on relapsed pediatric osteosarcoma patients, with vactosertib administered as monotherapy. The study builds upon encouraging results from preclinical and Phase 1 trials, where the drug demonstrated safety and potential efficacy in inhibiting both osteosarcoma cell growth and lung metastasis.
Collaborative Research Network
The trial will be conducted across 12 research institutions under the POETIC consortium, a North American organization that facilitates collaboration between pediatric oncology physicians, scientists, and pharmaceutical companies. POETIC's involvement underscores the significance of this research initiative in advancing pediatric cancer treatment.
"MedPacto was the only Korean company invited to the POETIC conference, reflecting North America's keen interest in our osteosarcoma clinical trials," stated MedPacto President Woo Jong-won. "We are excited about collaborating with top-tier U.S. university hospitals and have high expectations for the trial's outcome."
The trial is scheduled to commence within the year, marking a significant step forward in addressing the therapeutic challenges of pediatric osteosarcoma.
