Fennec Pharmaceuticals Presents Real World Data Supporting the Integration and Clinical Use of PEDMARK(TM) in Treating Adults with Head & Neck Cancers

Executive Summary

• Fennec Pharmaceuticals presented real‑world evidence that PEDMARK® can be safely administered ≥ 6 hours after cisplatin in adults with head and neck cancer, preserving cisplatin’s antitumor activity.
• In a retrospective review of 15 high‑risk adult patients, the majority experienced no measurable hearing loss despite baseline impairment; only isolated, self‑limited infusion events were reported.
• The data were showcased as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium, supporting broader clinical adoption of PEDMARK® for otoprotection in adult oncology populations.

Key Details

• Study Design: Multi‑institutional retrospective review; 15 adult HNC patients receiving cisplatin + PEDMARK® ≥ 6 h post‑infusion.
• Primary Endpoint – Feasibility: All patients adhered to the ≥ 6‑hour timing; administration settings included both home and clinic infusions with acceptable chair time.
• Secondary Endpoints:
• Infusion‑related events were limited to isolated, self‑limited reactions; no Grade 3/4 toxicities observed.
• No increase in antiemetic requirements versus cisplatin alone.
• Complete on‑treatment and post‑treatment audiology assessments performed.
• Hearing Outcomes: Majority of high‑risk patients (including those with pre‑existing impairment) showed no measurable hearing loss during or after treatment.
• Safety Profile: Well tolerated; isolated infusion events only; no Grade 3/4 adverse events.
• Regulatory Context: PEDMARK® is FDA‑approved for pediatric solid tumors and carries NCCN 2A endorsement for adolescent/young adult use; not yet approved for adult indications.
• Commercial Implications: Findings bolster the case for expanding PEDMARK® into adult oncology markets, potentially increasing addressable patient population (≈ 500 k U.S. patients annually receiving platinum‑based chemotherapy).
• Presentation Venue: Digital poster at 2026 Multidisciplinary Head and Neck Cancers Symposium (Palm Desert, CA; Feb 19‑21, 2026).

Notable Quotes

“These new findings are critical to demonstrating the feasibility, scalability and long‑term value of PEDMARK® beyond those studied in our pivotal clinical program.” – Pierre S. Sayad, PhD, M.S., Chief Medical Officer, Fennec Pharmaceuticals

“The data support the potential of the drug to address cisplatin‑induced hearing loss… without compromising cisplatin’s proven antitumor activity.” – Maria A. Velez, MD, MS, Co‑author, UCLA Health

Materiality Assessment: Material – Positive (introduces clinically relevant data that could expand the approved use of PEDMARK® into a large adult oncology market).