« Previous | All Messages |  ADH Message Board Home | recommend post |  Ignore Poster

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

"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.

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.

About Oregon Health & Sciences University (OHSU)

Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government), with 12,400 employees. OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.

This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. Such forward-looking statements include, without limitation, those regarding the development plans of the Company and the expected timing or results of our development. We can provide no assurance that such development will proceed as currently anticipated or that the expected timing or results of such development will be realized. We are subject to various risks, including the uncertainties of clinical trials, drug development and regulatory review, the early stage of our product candidates, our reliance on collaborative partners, our need for additional capital to fund our operations, our history of losses, and other risks inherent to the biopharmaceutical industry. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sedar.com and www.sec.gov.