University of Arizona Cancer Center has launched a Phase I/II open-label study evaluating intravenous sodium thiosulfate injection (PEDMARK®) in adolescent and young adult patients with head and neck or testicular cancers receiving cisplatin. The trial will assess otoprotection efficacy based on hazard ratio risk reduction compared to historical controls and measure systemic elimination of unbound cisplatin up to six hours post infusion under principal investigators Lisa Davis and Alejandro Recio-Boiles.

In the past six months, Fennec has supported two additional investigator-sponsored studies: a trial at Tampa General Hospital evaluating PEDMARK®’s real-world clinical utility in preventing cisplatin-induced hearing loss in AYA and adult cancer patients and a City of Hope study assessing otoprotection in adult men with metastatic testicular germ cell tumors. Several further submissions are under review to explore PEDMARK® in additional tumor types and patient cohorts.

Fennec aims to leverage the data generated from these independent trials to engage regulatory authorities on potential label expansion for PEDMARK®. The company believes accumulated real-world evidence will validate PEDMARK®’s benefit beyond pediatric indications, strengthening its positioning as the first FDA-approved otoprotectant for platinum chemotherapy.

Cisplatin use in solid tumors often causes permanent ototoxicity in 60-90% of patients, leading to lifelong hearing impairments requiring assistive devices. By mitigating irreversible hearing loss, PEDMARK® has the potential to improve quality of survivorship and reduce long-term healthcare costs associated with cochlear implants and hearing aids.