Fennec: Phase I/II Study of PEDMARK in AYA/Adult Cancer

On April 7, 2026, Fennec Pharmaceuticals announced the initiation of an investigator-sponsored Phase I/II study by the University of Arizona Cancer Center. The trial will evaluate PEDMARK (sodium thiosulfate injection) as an otoprotectant in adolescent, young adult (AYA), and adult patients with head, neck, and testicular cancers receiving cisplatin chemotherapy. The study aims to determine the efficacy of intravenous sodium thiosulfate in reducing cisplatin-induced hearing impairment compared to historical control data and will monitor the systemic elimination of unbound cisplatin. PEDMARK is currently FDA-approved to reduce the risk of ototoxicity in pediatric patients (1 month and older) with localized, non-metastatic solid tumors. This new study is part of a broader effort by Fennec to expand real-world validation and support potential label expansion for adult populations. It follows other recently initiated institution-led trials at Tampa General Hospital and City of Hope. The company believes data from these studies will support broader clinical adoption and potential regulatory pathways for label expansion in AYA and adult cancer patients.