Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FENC), a specialty pharmaceutical company, has announced a significant clinical research collaboration with Tampa General Hospital (TGH) Cancer Institute. This partnership marks the initiation of a real-world clinical study evaluating the utility of PEDMARK® (sodium thiosulfate injection) in reducing the risk of ototoxicity (hearing loss) in adolescent, young adult (AYA), and adult cancer patients receiving cisplatin-based chemotherapy.

Details of the Clinical Study

• The study focuses on the real-world evaluation of PEDMARK® in preventing hearing loss caused by cisplatin chemotherapy, which is widely used to treat solid tumors.
• Ototoxicity is a major side effect of cisplatin, with 60-90% of patients potentially affected. The resulting hearing loss is often permanent and can significantly impact quality of life, academic performance, career potential, and independence.
• The initiative is led by Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs at TGH Cancer Institute and principal investigator.
• Collaboration includes the USF Health Morsani College of Medicine, further strengthening the study’s academic and clinical rigor.
• The study will utilize real-world clinical data and audiology monitoring, aiming to inform future clinical research and quality efforts in managing ototoxicity.

Regulatory and Clinical Background

• PEDMARK® is the first and only FDA-approved therapy designed to reduce cisplatin-induced ototoxicity in pediatric patients (aged 1 month and older) with localized, non-metastatic solid tumors. It is also recommended by the National Comprehensive Cancer Network (NCCN) with a 2A endorsement for AYA patients.
• Proven efficacy and safety data established through two open-label, randomized Phase 3 clinical studies: COG ACCL0431 and SIOPEL 6.
• Prior to PEDMARK’s approval, there were no preventative agents for this type of hearing loss.
• FDA approval in September 2022, European Commission approval in June 2023, and UK approval in October 2023 (under the brand name PEDMARQSI®).
• Exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for commercialization in Europe, UK, Australia, and New Zealand; PEDMARQSI is commercially available in the UK and Germany.
• PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, with 8+2 years of protection. Patents provide protection until 2039 globally.

Safety and Usage Information

• PEDMARK® is indicated for pediatric patients (1 month and older) with localized, non-metastatic solid tumors.
• Limitations: Safety and efficacy not established for cisplatin infusions longer than 6 hours; not indicated for pediatric patients under 1 month due to risk of hypernatremia or for those with metastatic cancers.
• Adverse reactions include hypersensitivity (8-13%), hypernatremia (12-26%), hypokalemia (15-27%), vomiting, nausea, and decreased hemoglobin. Monitoring of sodium and potassium levels is required.
• Contraindicated in patients with severe hypersensitivity to sodium thiosulfate or its components.

Market Opportunity and Impact

• Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy.
• Ototoxicity remains a substantial unmet need, with a high incidence and long-term impact on quality of life; PEDMARK® is currently the only preventative agent available.
• The expansion of real-world evidence through this study could further validate PEDMARK’s clinical utility, potentially accelerating adoption and supporting reimbursement decisions.
• Positive results and broader recognition of PEDMARK’s effectiveness in diverse patient populations could significantly increase the addressable market and drive revenue growth.
• Licensing and commercialization milestones in Europe, U.K., Australia, and New Zealand, along with patent protection until 2039, bolster Fennec’s competitive position and revenue potential.

Forward-Looking Statements & Risks

• Statements regarding business strategy, commercialization plans, market opportunity, regulatory milestones, and expected benefits are forward-looking and subject to risks.
• Risks include regulatory changes, scientific or manufacturing challenges, market size uncertainties, patent protection challenges, revenue sufficiency for development, capital requirements, and unforeseen global events.

Contact Information

• Investors: Robert Andrade, Chief Financial Officer, Fennec Pharmaceuticals Inc. (+1 919-246-5299)
• Media: Lindsay Rocco, Elixir Health Public Relations (+1 862-596-1304, [email protected])

Analysis for Investors: Potential Share Price Impact

• This clinical collaboration represents a key milestone in expanding real-world evidence and market acceptance of PEDMARK®, potentially increasing its adoption and supporting future growth.
• New data could enhance the value proposition for payers and clinicians, potentially driving increased sales and improving Fennec’s competitive position.
• Milestones achieved in global commercialization, exclusivity, and patent protection provide long-term revenue visibility and may positively influence investor sentiment and share price.
• Risks remain around clinical outcomes, regulatory environments, and commercial execution, but positive developments in this collaboration could be material and price-sensitive for shareholders.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The information is based on press releases and public filings from Fennec Pharmaceuticals Inc. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. Investors should review all relevant filings and consult with professional advisors before making investment decisions.

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