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PEDMARK is an investigational drug and has not yet been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

About Pedmark

PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) is a water-soluble thiol compound and acts as a chemical reducing agent. Delayed administration (4–8 h) of high dose PEDMARKTM (16–20 g/m²) protects against platinum-induced ototoxicity in animal models and in patients.

Mechanism of Action

PEDMARKTM has the potential to prevent chemotherapy-induced hearing loss and be the first available agent approved for this condition.

PEDMARKTM was studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. The cancers being studied in the two studies are very rare, although the burden of ototoxicity is disproportionate among affected children due to the efficacy of cisplatin in these diseases. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients.

 DOWNLOAD A PRESENTATION demonstrating the hearing differences for those on PEDMARKTM

The Opportunity

Currently, there are no commercially available drugs to prevent cisplatin-induced hearing loss.

Fennec Pharma has received Orphan Drug Designation in the U.S. for the use of PEDMARKTM in the prevention of platinum-induced ototoxicity in pediatric patients, providing seven and a half years of market exclusivity upon regulatory approval. Orphan Drug Designation does not indicate regulatory approval.

In August 2018, Fennec was advised that PEDMARKTM is eligible for submission of an application for a Pediatric Use Marketing Authorisation (PUMA). The PUMA is a dedicated marketing authorization covering the indication and appropriate formulation for medicines developed exclusively for use in the pediatric population and provides data and market protection up to 10 years for PEDMARK. PUMA does not indicate regulatory approval.


Fennec Pharma licensed one US and 9 foreign patents from Oregon Health and Science University for STS. The STS methods of use patents expire in Europe and Japan in 2021 and are currently pending in the US.

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