Fennec Pharmaceuticals Announces Clinical Research Collaboration with Tampa General Hospital Cancer Institute

Executive Summary

• Tampa General Hospital Cancer Institute, in partnership with USF Health Morsani College of Medicine, has launched a real‑world study to evaluate PEDMARK® (sodium thiosulfate) for reducing cisplatin‑induced ototoxicity in adolescent, young adult and adult cancer patients.
• The study will collect clinical utility data and audiology monitoring results to inform future research, guideline updates, and quality‑of‑care initiatives.
• PEDMARK® is already FDA‑approved for pediatric patients and carries a NCCN 2A recommendation for AYA use; the new data could expand its perceived value across broader patient populations.

Key Details

• Study Sponsor: Tampa General Hospital (TGH) Cancer Institute, collaborating with USF Health Morsani College of Medicine.
• Principal Investigator: Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs, TGH Cancer Institute.
• Therapeutic Agent: PEDMARK® (sodium thiosulfate injection).
• FDA‑approved for pediatric patients ≥1 month old with localized non‑metastatic solid tumors.
• NCCN 2A recommendation for adolescent and young adult (AYA) patients.
• Objective: Evaluate real‑world clinical utility of PEDMARK® in reducing ototoxicity risk among AYA and adult cancer patients receiving cisplatin‑based chemotherapy.
• Data Collection: Real‑world clinical outcomes, audiology monitoring, safety observations; intended to support future clinical research and quality‑improvement efforts.
• Company Comment (Chief Medical Officer): Pierre S. Sayad, PhD, M.S., highlighted the importance of real‑world evidence for demonstrating PEDMARK®’s role in protecting hearing across diverse patient groups.
• Background Context:
• Cisplatin ototoxicity affects 60–90 % of patients, often leading to permanent hearing loss and lifelong device dependence.
• Prior Phase 3 trials (COG ACCL0431, SIOPEL 6) demonstrated efficacy in pediatric populations; the current study extends investigation to older cohorts.
• Regulatory Status: PEDMARK® holds U.S. FDA approval (Sept 2022), European Commission approval (June 2023), and UK approval (Oct 2023).

Notable Quotes

“Real‑world evidence plays a critical role in demonstrating the clinical utility of PEDMARK® across diverse patient populations and tumor types,” – Pierre S. Sayad, PhD, M.S., Chief Medical Officer, Fennec Pharmaceuticals

“This evaluation will examine real‑world clinical data and audiology monitoring that will help inform future clinical research and quality efforts in assessing, preventing and managing ototoxicity.” – Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs, TGH Cancer Institute