Fennec Pharmaceuticals announced the initiation of a new investigator-sponsored study at the University of Arizona Cancer Center to evaluate the use of PEDMARK in adolescent, young adult, and adult patients undergoing cisplatin chemotherapy for head and neck and testicular cancers.
The Phase I/II open-label trial will examine whether PEDMARK (sodium thiosulfate injection) can reduce cisplatin-induced ototoxicity, a form of permanent hearing loss that affects a significant portion of cancer patients receiving platinum-based treatments. The study will also assess how the drug influences systemic elimination of unbound cisplatin up to six hours after infusion.
PEDMARK is currently approved in the United States for pediatric patients with localized, non-metastatic solid tumors and has received a 2A recommendation from the National Comprehensive Cancer Network for use in adolescent and young adult populations. The new study reflects broader efforts to expand clinical evidence supporting its use in older patient populations.
This trial builds on additional institution-led research initiatives. In March 2026, the Tampa General Hospital Cancer Institute launched a study evaluating PEDMARK’s real-world effectiveness in reducing ototoxicity in AYA and adult patients. Earlier, in December 2025, City of Hope initiated a study focused on preventing cisplatin-induced hearing loss in adult men with metastatic testicular cancer.
Cisplatin-based chemotherapy remains a cornerstone of treatment for many solid tumors, but it carries a high risk of irreversible hearing loss, with studies indicating that between 60 percent and 90 percent of patients may be affected depending on dosage and duration. This adverse effect can significantly impact quality of life, including communication abilities, academic and professional outcomes, and long-term independence.
PEDMARK is the first and only FDA-approved therapy designed to reduce the risk of cisplatin-induced ototoxicity. Its approval was supported by two Phase 3 clinical trials, including the Children’s Oncology Group ACCL0431 and SIOPEL 6 studies, which demonstrated efficacy and safety in pediatric populations.
The ongoing expansion of investigator-initiated studies is expected to generate additional real-world evidence across broader tumor types and patient populations, potentially supporting future regulatory pathways for label expansion and wider clinical adoption.
KEY QUOTES:
“At Fennec, we are committed to supporting independent research efforts, which help build real-world evidence and expand understanding of how PEDMARK may benefit patients beyond the populations studied in our pivotal trials. Within the last few months, we have announced the initiation of three new studies with leading and highly respected academic and community oncology centers. We believe that data and insights generated through these studies – and others to come – will help support broader clinical adoption of PEDMARK to prevent ototoxicity, or permanent hearing loss, in AYA and adult cancer patients receiving cisplatin-based treatment. We look forward to continued dialogue with regulatory authorities regarding the potential pathways for PEDMARK label expansion as our growing body of evidence-based data matures.”
Pierre S. Sayad, Chief Medical Officer, Fennec Pharmaceuticals Inc.
