Fennec Pharmaceuticals Announces Investigator-Sponsored Trial to Be Conducted by City of Hope in Metastatic Testicular Germ Cell Tumors

Executive Summary

• Fennec Pharmaceuticals announced that City of Hope will initiate an investigator‑sponsored Phase I study (NCT07218913) to evaluate PEDMARK® (sodium thiosulfate injection) for preventing cisplatin‑induced ototoxicity in adult men with stage II‑III metastatic testicular germ‑cell tumors.
• The study expands the clinical evidence base of PEDMARK® beyond its current pediatric indication into a metastatic adult population where cisplatin is widely used.
• Fennec highlighted multiple additional investigator‑initiated studies under review, indicating an expanding pipeline of clinical collaborations to strengthen its commercial and development platform.

Key Details

• Study Sponsor: City of Hope (Duarte, California) – Principal Investigator: Dr. Alexander Chehrazi‑Raffle, M.D.
• Title: Testing the Addition of PEDMARK® to Cisplatin Chemotherapy for Reducing Drug‑Induced Ear Damage in Men With Stage II‑III Metastatic Testicular Germ Cell Tumors.
• Design: Phase I, investigator‑initiated trial (NCT07218913) evaluating safety and otoprotective efficacy of PEDMARK® when added to standard cisplatin‑based chemotherapy.
• Target Population: Adult men with stage II‑III metastatic testicular germ‑cell tumors receiving cisplatin‑based regimens.
• Rationale: Up to 90 % of patients treated with cisplatin develop some degree of permanent hearing loss; PEDMARK® is the only FDA‑approved otoprotective agent for pediatric solid‑tumor patients and is NCCN‑endorsed for adolescent/young adult use.
• Regulatory Status of PEDMARK®: FDA approval (Sept 2022); EMA approval (June 2023) and UK approval (Oct 2023) under the brand name PEDMARQSI®. Orphan Drug exclusivity in the U.S.; Pediatric Use Marketing Authorization in Europe with protection through 2039.
• Commercial Arrangement: In March 2024, Fennec entered an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. to commercialize PEDMARQSI® in Europe, the UK, Australia, and New Zealand; product now available in the UK and Germany.
• Future Pipeline: Several additional investigator‑initiated studies have been submitted to Fennec and are at various stages of contracting or evaluation, expected to further expand clinical data and commercial opportunities for PEDMARK®.

Notable Quotes

• “Cisplatin has transformed outcomes… however, as many as four out of five survivors are left with permanent hearing loss.” – Dr. Alexander Chehrazi‑Raffle, City of Hope.
• “The initiation of this study reflects the growing clinical interest in addressing the burden of hearing loss among patients receiving cisplatin‑based chemotherapy.” – Pierre S. Sayad, PhD, M.S., Chief Medical Officer, Fennec Pharmaceuticals.