Fennec Pharmaceuticals Announces Major Clinical Expansion for PEDMARK® in New Patient Populations

Key Highlights from Latest Corporate Update

• Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX) announced a new investigator-sponsored study at the University of Arizona Cancer Center, aiming to expand the use of PEDMARK® (sodium thiosulfate injection) in adolescent, young adult (AYA), and adult patients with solid tumors receiving cisplatin, including head and neck and testicular cancers.
• PEDMARK® is currently the only FDA-approved therapy for reducing the risk of ototoxicity (hearing loss) in pediatric patients 1 month and older with localized, non-metastatic solid tumors. It also has a 2A recommendation from the National Comprehensive Cancer Network (NCCN) for use in AYA patients.
• Fennec has recently initiated or supported three new independent, institution-led clinical studies, marking significant real-world validation and potential label expansion opportunities for PEDMARK®.

Details of New Clinical Studies

• University of Arizona Cancer Center Study:
  • Title: Phase I/II Open-Label Trial of Intravenous Sodium Thiosulfate (PEDMARK®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy
  • Principal Investigators: Lisa Davis / Alejandro Recio-Boiles
  • Aim: To determine the efficacy of PEDMARK® in reducing hearing impairment from cisplatin and measure systemic elimination of unbound cisplatin post-infusion.
• Other Recent Studies:
  • Tampa General Hospital Cancer Institute: Study initiated in March 2026 to evaluate the real-world clinical utility of PEDMARK® in reducing ototoxicity in AYA and adult patients on cisplatin-based regimens.
  • City of Hope (December 2025): Study in adult men with stage II-III metastatic testicular germ cell tumors to assess PEDMARK® for prevention of cisplatin-induced ototoxicity.
  • Additional investigator-initiated studies for new tumor types and patient groups have been submitted and are under review.

Potential Impact for Investors and Shareholders

• Potential for Label Expansion: The company is actively generating real-world data supporting the use of PEDMARK® beyond its current approval in pediatric patients, including AYA and adult populations. Expanding the label could significantly increase the addressable market, which currently stands at approximately 500,000 U.S. patients annually who receive platinum-based chemotherapy.
• Broader Clinical Adoption: Fennec sees these studies as pivotal for supporting regulatory discussions and the potential for PEDMARK® to become standard of care for otoprotection in a much larger patient population.
• Strategic Partnerships and Global Reach:
  • PEDMARK® received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 (under the brand name PEDMARQSI®).
  • In March 2024, Fennec entered an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for commercialization in Europe, U.K., Australia, and New Zealand. PEDMARQSI® is now commercially available in the U.K. and Germany.
  • PEDMARK® enjoys Orphan Drug Exclusivity in the U.S. and equivalent pediatric use protection in Europe, ensuring market protection for up to 10 years.
• Market Opportunity: Until PEDMARK®, there were no approved preventative agents for cisplatin-induced hearing loss. Studies indicate 60–90% of patients receiving cisplatin may develop ototoxicity, resulting in significant quality-of-life burdens and long-term costs for survivors.
• Pipeline and Regulatory Risk: The company notes ongoing regulatory interactions about potential label expansion, but also highlights risks related to regulatory changes, market size, ability to penetrate new markets, and sufficient data for expanded indications.

Clinical Background and Safety Profile

• PEDMARK® is a unique, ready-to-use sodium thiosulfate formulation with proven efficacy and safety in two open-label, randomized Phase 3 studies (COG ACCL0431 and SIOPEL 6).
• Indication: Approved for pediatric patients (≥1 month old) with localized, non-metastatic solid tumors receiving cisplatin.
• Safety: Most common adverse reactions include vomiting, nausea, decreased hemoglobin, hypernatremia, and hypokalemia. PEDMARK® is contraindicated in patients with severe hypersensitivity to sodium thiosulfate and not for use in patients under 1 month or with metastatic cancers.
• See full prescribing information at www.PEDMARK.com.

Management Commentary

“At Fennec, we are committed to supporting independent research efforts, which help build real-world evidence and expand understanding of how PEDMARK® may benefit patients beyond the population studied in our pivotal trials… We believe that data and insight generated through these studies – and others to come – will help support broader clinical adoption of PEDMARK® to prevent ototoxicity, or permanent hearing loss, in AYA and adult cancer patients receiving cisplatin-based treatment. We look forward to continued dialogue with regulatory authorities regarding the potential pathways for PEDMARK® label expansion as our growing body of evidence-based data matures.”
— Pierre S. Sayad, PhD, M.S., Chief Medical Officer

Contact Information

• Investors: Robert Andrade, Chief Financial Officer, +1 919-246-5299
• Media: Lindsay Rocco, Elixir Health PR, +1 862-596-1304, [email protected]

Disclaimer

This article contains forward-looking statements based on current information and management’s expectations. Actual results may differ due to regulatory, clinical, market, or other risks. Investors should review Fennec Pharmaceuticals’ filings with the SEC and SEDAR for more details. This article is for informational purposes only and does not constitute investment advice. Please consult your financial advisor before making investment decisions.

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