Adherex opens Ph III STS trial

US drugmaker Adherex Technologies says that the planned Phase III trial of sodium thiosulfate (STS) in children with liver cancer has opened for patient enrollment in the UK, with centers run by the USA's International Childhood Liver Tumour Strategy Group in up to 33 further countries also expected to participate.

The multicenter, prospective randomized Phase III clinical trial is expected to enroll approximately 100 evaluable children with hepatoblastoma, an orphan disease, being treated with cisplatin. Patients will be randomized to receive either cisplatin alone, a platinum-based drug associated with frequent hearing loss used to treat hepatoblastoma, or cisplatin plus STS. The study, which will be coordinated through the Children's Cancer and Leukaemia Group in the UK, will compare the level of hearing loss associated with cisplatin alone versus the combination of cisplatin plus STS, as well as the safety, tolerability and anti-tumor activity in both arms of the study.

Adherex has received orphan drug designation from the US Food and Drug Administration for the use of STS for the prevention of platinum-induced ototoxicity in pediatric patients.