Adherex Technologies Inc., a biopharmaceutical company specializing in discovery and development of cancer therapeutics, has begun a Phase III trial for sodium thiosulfate (STS), a drug to prevent hearing loss in children receiving chemotherapy.
Research Triangle Park-based Adherex is running the trial in collaboration with the Children's Oncology Group (COG). COG is the world's largest and most recognized pediatric cancer research collaborative with more than 5,000 members located at more than 200 leading children's hospitals, university hospitals and cancer centers in North America.
Hearing loss is a significant side effect associated with platinum-based chemotherapies, such as cisplatin, used to treat many childhood cancers. Currently, there are no commercially available drugs to prevent this type of hearing loss.
"The clinical consequences of cisplatin related hearing loss are frequent and significant," said Dr. Edward Neuwelt, Professor of Neurosurgery, Oregon Health & Science University, who has been involved in the development of STS for over a decade. "Our studies have demonstrated that over 60 percent of children with cancer receiving cisplatin therapy will develop some hearing loss, many will require lifelong hearing aids, and some will become deaf."
The trial is expected to enroll up to 120 patients over approximately three years in up to 230 COG centers in the United States, Canada, Australia and Europe.
Adherex is also conducting a Phase III trial of STS in children with liver (hepatoblastoma) cancer in collaboration with the International Childhood Liver Tumour Strategy Group (known as SIOPEL), with centers in up to 33 countries expected to participate.