RESEARCH TRIANGLE PARK, N.C. — March 4, 2026 — Leads & Copy — The Tampa General Hospital (TGH) Cancer Institute is launching a study to assess the clinical utility of sodium thiosulfate injection (PEDMARK®) in reducing ototoxicity risk in adolescent, young adult, and adult cancer patients undergoing cisplatin treatment, Fennec Pharmaceuticals Inc. announced today.
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FRX), is a specialty pharmaceutical company. PEDMARK® is FDA-approved for pediatric patients one month and older with localized non-metastatic solid tumors. It also has a 2A recommendation from the National Comprehensive Cancer Network for use in adolescent and young adult patients.
Dr. Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs at the TGH Cancer Institute and the initiative’s principal investigator, said the TGH Cancer Institute, in collaboration with the USF Health Morsani College of Medicine, is committed to advancing otoprotective strategies to preserve auditory function in patients receiving cisplatin chemotherapy. He added that the evaluation will examine real-world clinical data and audiology monitoring to inform future clinical research and quality efforts in assessing, preventing, and managing ototoxicity.
Dr. Pierre S. Sayad, chief medical officer of Fennec Pharmaceuticals, said that real-world evidence demonstrates PEDMARK®’s clinical utility across diverse patient populations and tumor types. He added that as more institutions generate data outside controlled trials, clinicians will gain a clearer picture of PEDMARK®’s role in providing hearing loss protection for patients receiving cisplatin.
Cisplatin and other platinum-based chemotherapies are commonly used to treat solid tumors and have improved survival rates. However, these treatments often cause permanent hearing loss, also known as ototoxicity.
Studies indicate that 60-90% of patients treated with cisplatin may develop hearing loss, depending on the dosage and duration of chemotherapy. Many require lifelong hearing aids or cochlear implants, which can be costly and do not reverse the hearing loss. Treatment-induced hearing loss can reduce quality of life, impacting speech and language skills, academic performance, social-emotional development, career potential, and the ability to live independently.
PEDMARK® (sodium thiosulfate injection) is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients one month and older with localized, non-metastatic, solid tumors. It is a sodium thiosulfate formulation in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK has proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, COG Protocol ACCL0431 and SIOPEL 6.
Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with platinum-based chemotherapy. Before PEDMARK’s FDA approval, there were no preventative agents for this hearing loss. Patients with hearing loss from cancer treatment have a statistically significant worse quality of life compared to those without hearing loss.
PEDMARK has been studied in two Phase 3 clinical studies of survival and ototoxicity reduction, COG ACCL0431 and SIOPEL 6. COG ACCL0431 enrolled children with cancers typically treated with intensive cisplatin therapy, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
PEDMARK is contraindicated in patients with a history of severe hypersensitivity to sodium thiosulfate or any of its components. Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Patients should be monitored for hypersensitivity reactions, and antihistamines or glucocorticoids should be administered (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite, which can cause hypersensitivity reactions in sulfite-sensitive individuals.
PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers. Hypernatremia occurred in 12% to 26% of patients in clinical trials, while hypokalemia occurred in 15% to 27% of patients. Serum sodium and potassium levels should be monitored at baseline and as clinically indicated. Antiemetics should be administered prior to each PEDMARK administration.
The most common adverse reactions in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK® at: www.PEDMARK.com.
Fennec Pharmaceuticals Inc. is focused on commercializing PEDMARK® to reduce platinum-induced ototoxicity risk in cancer patients. PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI.
In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. to commercialize PEDMARQSI® in Europe, U.K., Australia, and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany.
PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe. Fennec has patents providing protection for PEDMARK until 2039 in the U.S. and internationally.
Tampa General Hospital is a 1,530-bed not-for-profit hospital and outpatient services network spanning across Florida. USF Health is dedicated to making life better through research, education and patient care.
Source: Fennec Pharmaceuticals
