Core Insights - Fennec Pharmaceuticals is initiating a study at Tampa General Hospital to evaluate the clinical utility of sodium thiosulfate injection (PEDMARK) in reducing ototoxicity risk in adolescent and young adult (AYA) and adult patients undergoing cisplatin chemotherapy [1][2] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on combating ototoxicity in cancer patients receiving cisplatin-based chemotherapy [18] - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors [6][10] - The company received FDA approval for PEDMARK in September 2022 and has since expanded its market presence with approvals in Europe and the UK [18][19] Clinical Study and Research - The study at Tampa General Hospital aims to gather real-world clinical data and audiology monitoring to inform future research and quality efforts in managing ototoxicity [2][3] - The evaluation will help demonstrate the clinical utility of PEDMARK across diverse patient populations and tumor types, enhancing understanding of its role in hearing loss protection [3] Ototoxicity Context - Cisplatin and other platinum-based chemotherapies are essential for treating solid tumors but can lead to significant hearing loss, affecting 60-90% of patients depending on treatment specifics [4][5] - Hearing loss from cisplatin treatment can severely impact quality of life, necessitating lifelong hearing aids or cochlear implants for many patients [5][8] Regulatory and Market Position - PEDMARK is recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in AYA patients, indicating its importance in clinical practice [2][7] - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, highlighting a substantial market opportunity for PEDMARK [7]