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news.The US Food and Drug Administration's (FDA) Pediatric Subcommittee of the Oncologic Drugs Advisory Committee will discuss on Adherex Technologies' Sodium Thiosulfate Injection, USP, 25% (STS) development.
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STS is a chemoprotectant used to reduce or prevent hearing loss in children resulted from the treatments utilizing platinum-based chemotherapy drugs.
STS is currently being studied in two Phase III clinical studies of survival and reduction of ototoxicity.
Children’s Oncology Group (COG) is conducting a randomized Phase III Study ACCL0431 of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children.
The International Childhood Liver Tumour Strategy Group is conducting a multicentre open label randomised phase III trial – SIOPEL 6 designed to assess the efficacy of Sodium Thiosulphate in reducing ototoxicity in patients receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma.
Adherex CEO Rosty Raykov said they look forward to discuss the development and path to approval for STS with the FDA’s Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.