Pedmark (sodium thiosulfate injection)

2022: Product Announcement

On September 20, 2022, Fennec Pharmaceuticals announced the launch of Pedmark (sodium thiosulfate injection) to reduce the risk of cisplatin-related ototoxicity in pediatric patients one month and older with localized, non-metastatic solid tumors. Pedmark is the first and only drug in this area with significant unmet medical demand.

Advances in chemotherapeutic therapies for pediatric patients with localized solid tumors continue to improve, resulting in a five-year survival rate of 85% or more for such patients. However, platinum-based chemotherapy, which is still a method of choice in many cases, can be toxic to the ears, and cisplatin treatment often causes permanent and irreversible bilateral hearing loss.

Intravenous Therapy on the Market to Prevent Chemotherapy-Induced Pediatric Hearing Loss

Persistent hearing loss is seen in about 60% of children treated with cisplatin and can be as high as 90%. Until now, hearing restoration techniques such as cochlear implants and hearing aids have only been used after hearing loss has been detected, and these measures do not fully return hearing.

The basis for the opportunity for Pedmark to enter the market was the safety and efficacy data obtained from two Phase 3, multicenter, open-label, randomized controlled trials (SIOPEL 6 and COG ACCL0431) in pediatric patients undergoing chemotherapy that compared Pedmark with cisplatin and cisplatin alone. In both studies, the incidence of hearing loss was consistent and significantly lower in the Pedmark group in combination with cisplatin compared to the cisplatin-only group (21.4% versus 73.3% and 32.7% versus 63% with hearing loss in COG ACCLO431 and SIOPEL6, respectively).

{{quote 'The launch of Pedmark represents an important breakthrough for pediatric patients with localized non-metastatic solid tumors at risk of cisplatin-induced hearing loss. Cisplatin is the most important drug used in standard therapy in the treatment of childhood cancers. Thanks to Pedmark, doctors have a certified treatment option to reduce the risk of cisplatin-induced hearing loss in pediatric patients, said Rosti Raikov, chief executive officer of Fennec Pharmaceuticals^[1] }}

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