Bethesda, MD, March 26 (AScribe Newswire) -- The Children's Oncology Group (COG), a pediatric cancer research collaborative in conjunction with the National Cancer Institute (NCI), and Adherex Technologies Inc., announced today the activation of a Phase III trial with sodium thiosulfate (STS), a drug being developed to protect against hearing loss caused by cisplatin, a commonly used platinum-based chemotherapy.
The goal of this multi-center study, entitled "A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children (ACCL0431)," is to evaluate whether STS is an effective and safe means of preventing hearing loss in children receiving cisplatin chemotherapy for newly diagnosed germ cell tumors, hepatoblastoma, medulloblastoma, neuroblastoma or osteoscarcoma. The study is expected to enroll approximately 120 children between 1 and 18 years of age in up to 230 COG institutions located in the United States, Canada, Australia and Europe.
"We have made significant improvements in the cure rates for many childhood cancers, but the side effects of the treatment can significantly affect the long-term quality of life. Cisplatin is a valuable cancer drug but is unfortunately associated with severe and permanent hearing loss in up to 60 percent of children treated. This can result in learning disabilities, social and behavioral issues and cognitive dysfunction," 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. "STS holds great promise for these kids with cancer by reducing or preventing hearing loss and the associated quality of life issues."
"The Children's Oncology Group is committed to eradicating childhood cancer. Increasingly, we are turning our attention to the long-term complications of therapy such as the hearing loss that this study addresses," said Dr. Gregory Reaman, Chairman, Children's Oncology Group. "It is an important part of our goal in improving the outcomes for all children with cancer and their families."
Approximately 60 percent of children with cancer receiving cisplatin therapy will develop some form of hearing loss. In excess of 800 children with these cancers are enrolled in Children's Oncology Group trials and based on 2007 National Cancer Institute data related to the number of children diagnosed with cancer, it is estimated that as many as 2,000 children are at risk to develop chemotherapy-related hearing loss annually.
"We have long believed that STS will be able to address this important problem in the treatment of cancer and are very pleased to launch with the Children's Oncology Group this clinical trial aimed at establishing the proper role for STS," said Dr. William P. Peters, Chairman and CEO, Adherex Technologies Inc. "We are in the business of solving problems for patients with cancer and are proud to participate with the Children's Oncology Group in helping children live more productive lives."
Patients will be randomized to receive either cisplatin alone, a platinum-based drug associated with frequent hearing loss, or cisplatin plus STS. The study will compare the level of hearing loss (ototoxicity) associated with cisplatin alone versus the combination of cisplatin plus STS. Efficacy of STS will be determined through comparison of hearing sensitivity at follow-up relative to baseline measurements using standard audiometric techniques. Hearing loss will be defined using published criteria from the American Speech-Language-Hearing Association (ASHA). It is hypothesized that the proportion of subjects with hearing loss will be reduced by 50 percent (in relative terms) in the STS group as compared to the control (the non-STS group)
About Children's Oncology Group:
The Children's Oncology Group is the world's largest cooperative childhood cancer research organization, treating more than 90 percent of children with cancer in the United States. The Children's Oncology Group includes more than 5,000 medical experts in childhood cancer research and treatment, located at more than 200 leading healthcare institutions in North America.
About Adherex Technologies:
Adherex Technologies Inc. is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics. We are in the business of solving problems for patients with cancer. We have multiple products in the clinical stage of development, including eniluracil, ADH-1 and sodium thiosulfate (STS). Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, is being developed to improve the tolerability and effectiveness of 5-fluorouracil (5-FU), one of the most widely used oncology drugs in the world. ADH-1 is a biotechnology compound which selectively targets N-cadherin, a protein present on certain tumor cells and the blood vessels of solid tumors. STS is a chemoprotectant being developed to reduce or prevent hearing loss that may result from treatment with platinum-based chemotherapy drugs. With a diversified portfolio of unique preclinical and clinical-stage cancer compounds and a management team with expertise in identifying, developing and commercializing novel cancer therapeutics, Adherex aims to become a leader in developing innovative treatments that address important unmet medical needs in cancer. For more information, please visit our website at www.adherex.com.
Taken from: newswire.ascribe.org
