Durham, NC — Adherex Technologies Inc has announced that it is meeting with the FDA’s Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to discuss the development of Sodium Thiosulfate Injection, USP, 25% (STS) on November 1, 2011.
STS is a chemoprotectant that is being developed to reduce or prevent hearing loss in children that may result from the treatment of platinum-based chemotherapy drugs.
Thus far, STS has received Orphan Drug Designation in the United States for the prevention of platinum-induced ototoxicity in pediatric patients. In addition, Adherex has licensed from Oregon Health & Science University intellectual property rights for the use of STS as a chemoprotectant.
STS is a water-soluble thiol compound that acts as a chemical reducing agent. Currently, it is approved for the treatment of cyanide poisoning. It is thought that hearing loss caused by platinum chemotherapy compounds results from the deposits of protein-bound platinum in the cochlea. STS is known to bind to platinum/protein complexes, thereby potentially minimizing their toxicity.
STS is currently being studied in two Phase III clinical studies of survival and reduction of ototoxicity. The first, a randomized Phase III study being conducted by the Children’s Oncology Group (COG), is expected to enroll 135 patients with diagnoses of one of five childhood cancers typically treated with intensive cisplatin therapy.
The second trial is a multi-center randomized Phase III trial for reducing ototoxicity in patients receiving cisplatin for hepatoblastoma. The trial is being conducted by The International Childhood Liver Tumour Strategy Group, which is expected to enroll 102 patients.
SOUCE: Adherex Inc