Adherex Announces Phase III Trial With STS in Collaboration With the Children’s Oncology Group

Adherex Technologies Inc. (AMEX:ADH, TSX:AHX), a biopharmaceutical company devoted to solving problems for patients with cancer, announced today the activation of a Phase III trial with sodium thiosulfate (STS) to prevent hearing loss in children receiving cisplatin-based chemotherapy in collaboration with the Children’s Oncology Group (COG).



“The great progress that has been made in the curative treatments of childhood cancer is often marred by the significant long-term hearing disability that can result from the necessary cisplatin treatment. The activation of this Phase III trial of STS with the Children’s Oncology Group is an important step in our efforts to solve this problem for kids with cancer,” said Dr. William P. Peters, Chairman and CEO of Adherex. “Through this Phase III trial and our ongoing Phase III trial with the International Childhood Liver Tumour Strategy Group (known as SIOPEL), we aim to globally recruit as many eligible children with cancer as quickly as possible to help prevent the hearing loss that these children and their parents have had to accept as part of their cancer treatment.”



“As many as 2,000 children with cancer are at risk for platinum chemotherapy related hearing loss annually,” said Dr. David Freyer, Professor of Medicine, Childrens Hospital Los Angeles, Keck School of Medicine of the University of Southern California and principal investigator for the trial. “This hearing loss often leads to long-term learning and developmental issues for these children. With over 5,000 medical experts and over 200 participating children’s and university hospitals worldwide, the Children’s Oncology Group is very proud to offer its significant expertise and resources to help improve the quality of life for children with cancer.”



“The clinical consequences of cisplatin related hearing loss are frequent and significant,” said Dr. Edward Neuwelt, Professor of Neurosurgery, Oregon Health & Science University. “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. It is common for these children to be 2-4 years behind their peers in school. Younger children have been shown to have difficulty acquiring language skills. I have been involved in the development of STS for over a decade and am thrilled to see it entering late-stage development. I believe that this drug may have the ability to dramatically improve the long-term outcomes for these children.”



The goal of this Phase III study is to evaluate in a multi-centered, randomized trial whether STS is an effective and safe means of preventing hearing loss in children receiving cisplatin chemotherapy for newly diagnosed germ cell, liver (hepatoblastoma), brain (medulloblastoma), nerve tissue (neuroblastoma) or bone (osteosarcoma) cancers. Eligible children will be 1 to 18 years of age who are scheduled to receive cisplatin according to their disease-specific regimen and, upon enrollment onto this study, will be randomized to receive STS or placebo. Efficacy of STS will be determined through comparison of hearing sensitivity at follow-up relative to baseline measurements using standard audiometric techniques. 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 providing drug and drug distribution for the study and will have exclusive use of the results for regulatory submissions. Adherex exclusively licensed intellectual property rights directed to the use of STS as a chemoprotectant from Oregon Health & Science University (OHSU) and received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the use of STS for the prevention of platinum-induced ototoxicity in pediatric patients. Investigators at OHSU have previously conducted Phase I and Phase II studies with STS, which have shown that STS can reduce the hearing loss associated with platinum-based chemotherapy.



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), a multi-disciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology (SIOP), with centers in up to 33 countries expected to participate.
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