Fennec Pharmaceuticals Reports Positive Results for PEDMARK in Japanese Pediatric Cancer Study
Reuters
Dec 02, 2025
Fennec Pharmaceuticals Reports Positive Results for PEDMARK in Japanese Pediatric Cancer Study
Fennec Pharmaceuticals Inc. has announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial of PEDMARK® (sodium thiosulfate injection) in Japan. The study enrolled 27 pediatric and adolescent patients with non-metastatic solid tumors and demonstrated a significant reduction in cisplatin-induced hearing loss, with hearing loss rates of 16-24% compared to historically reported rates of 56-63% in patients receiving cisplatin alone. No interference with cisplatin's antitumor activity was observed, as evidenced by an approximate 95% clinical response rate. PEDMARK® was well-tolerated, with no adverse events attributed to the drug. Full study results will be presented at a future scientific meeting and submitted for publication. Fennec plans to pursue registration of PEDMARK® in Japan and is exploring partnering or licensing opportunities in the region.
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